PCORI Prostate Special Study Instructions

Data Collection Instructions for

Non-FORDS Standard Data Items

Special Study of Post-Active Treatment Surveillance in

Prostate Cancer

Version 1

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Page 1 of 86

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Web Form Instructions

Table of Contents Control-Click on the text below to navigate directly to each section

Table of Contents ...................................................................................................................................2

Overview ................................................................................................................................................3

Web form instructions............................................................................................................................5

Data collection instructions..................................................................................................................18

INSTRUCTIONS FOR PROSTATE STUDY ......................................................................................................... 19

NCDB Clinical Information

Comorbidities

Additional Clinical Information

Surveillance

PSA

Testosterone

Scan

Biopsy

Recurrence

New Cancer Diagnosis

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Overview The purpose of this study is to analyze data from the National Cancer Database (NCDB) to assess optimal post-

treatment surveillance PSA testing for the detection of cancer recurrence in patients treated with either primary

surgery or primary radiation for prostate cancer. In addition, we are looking for ways to improve the collection of

critical variables such as recurrence and comorbidity in order to increase the value of the NCDB for answering

research questions pertaining to outcomes for patients diagnosed with cancer.

The purpose of this document is to define standards for the collection of data elements that will be collected as a

part of the American College of Surgeons/Commission on Cancer Special Study. This document describes the

items for data collection, the codes to be used, and the instructions for coding, including recommended sources

for collecting each data item in the patient medical record.

All data items should be collected as defined in these instructions for selected cases of patients who were

diagnosed with prostate cancer. Medical record information should be collected beginning at the surveillance start

date (indicated in the web form in the “Patient Data” section that appears at the top of each page). The

surveillance period is the 8 years following the “surveillance start date” OR the date the selected patient

experiences a distant recurrence, as defined in this data dictionary, OR the date of death, whichever is first.

Definition of first treatment (only 2 possible treatments): either radical prostatectomy or radiation treatment,

whichever is the first treatment administered after diagnosis. Radiation treatment includes external beam radiation

and/or brachytherapy. Note: androgen deprivation therapy (ADT) is not considered first treatment. For patients

receiving treatment in the following order: 1) ADT, 2) surgery, 3) radiation, the primary treatment is surgery.

Definition of surveillance start date: For patients undergoing surgery as first course treatment, this date will be

the date of the radical prostatectomy surgery. For patients undergoing radiation treatment as first course treatment,

this will be the last date of external beam radiation or brachytherapy (if patient had both types of radiation, choose

the later date).

Definition of end of surveillance period: 8 years from the time of the surveillance start date or when the selected

patient experiences a distant recurrence, as defined in this data dictionary, or until their date of death, whichever is

first.

Dates at which to stop abstraction for different data fields:

1. PSA, Testosterone, Scan, and Biopsy tabs: stop entering data at end of surveillance period (defined above)

2. Treatments for Recurrence tab: stop entering data after the date of distant metastasis + 180 days. [e.g. if the

date of distant metastasis was 5/1/2008, then stop abstraction on 11/1/2008]

The collection of follow-up PSA tests, imaging and recurrence information is particularly critical to the

success of this study. The primary method for cancer surveillance after primary prostate cancer treatment

is PSA testing – so it is critical to obtain all PSA dates and values for this study, irrespective of where a

patient is receiving their follow-up care. The study must be able to ascertain 1) how often patients are

receiving PSA testing after primary treatment and 2) when a recurrence occurs (as defined by the PSA test

result). Patients often receive follow-up care outside of the institution where their cancer was diagnosed or

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initially treated, including other hospitals or physicians’ offices. As a result, it is likely that for many

patients, registrars will need to go outside their institution to other providers or hospitals to collect patient

medical records in order to comprehensively capture patient health care use following active treatment for

their cancer. The CoC has provided a letter template for this study that can be utilized to contact these

providers for patient information. Feedback from a pilot study and the 2015 special study looking at post-

treatment surveillance in breast, colorectal and lung cancers indicated that it is helpful to request as many

outside records for patients as necessary at the outset for data collection efficiency and to ensure you have

enough time to enter the data prior to the special study deadline.

If you find that any of the information in the patient’s NCDB record is incorrect, please update your registry

database. That will ensure the case will automatically be selected for submission to the NCDB during the next

Call for Data because of the change being made. For variables defined by FORDS manual standards and listed in

this document, registrars are to use the American College of Surgeons, Commission on Cancer Facility Oncology

Registry Data Standards (FORDS), Revised for 2016.

Note: The NCDB through the Commission on Cancer is a covered entity and uses follow-up information for

quality improvement purposes. Quality improvement is covered under health care operations with the Health

Insurance Portability and Accountability Act (HIPAA). Therefore, IRB approval is not necessary for this study.

Your efforts are critical to the success of the study and we are appreciative of your participation and time.

Email [email protected] or call (312) 202-5685 with questions or comments.

mailto:[email protected]

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Please note: Internet Explorer Version 8 or higher is the recommended browser for data entry on the web form.

On the Datalinks homepage, registrars and co-registrars will see the heading “Commission on Cancer Special Study.”

Underneath this heading, there is a link entitled “NCDB: Post-treatment surveillance in prostate cancer- PCORI.” When

you click on that link, you will be directed to our web form for the Special Study.

On the first page of the web form, each registrar will enter a username and password; this is the same login information

used to access Datalinks.

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On the second page of the web form, each registrar will see a dropdown list of the institution(s) with which he/she is

affiliated (this only applies if the registrar works for multiple institutions). Click on the institution. Alternatively, you can

type the facility name into the blank space.

When you click “Submit,” you will be taken to a page with the list of 12 patients for whom you need to collect data. Each

patient’s accession number, Special Study Patient ID, sequence number, date of diagnosis, date of most definitive surgery,

and age at diagnosis from current NCDB records and the surveillance start date are shown. The surveillance start date has

been calculated for you. This is the date that you should start collecting and recording information (PSA, imaging scans,

biopsies, recurrence, etc.) for the patient as the focus of the study concerns tests and recurrence/death events that take

place after this time.

Additionally, we have included a Special Study Patient ID. This is a randomly generated unique identifier given to each

patient. This should be used if you need to contact the study staff with a question about a specific patient. No patient or

provider information, including the accession number, should be sent to the study staff to ensure patient confidentiality.

More than one registrar per facility can be logged into the web form at the same time. However, registrars should not

access or enter information for the same patient at the same time as the data may not save properly.

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Once you have selected your facility, you will be taken to a page similar to what is shown below. The first section of this

page entitled “Patient Data to be Submitted” contains information for the 12 randomly selected patients whose data need

to be abstracted and submitted. Select a patient by clicking “Start,” as shown in the image below by the arrow.

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The web form for a selected test patient is shown below. Starting with the Determination of Eligibility tab, use the drop-

down feature to answer “Yes” or “No/Unknown” on each of the three eligibility questions. Each of these questions must

be answered “Yes” in order for that patient to be eligible (see more information on eligibility on page 18 of this

document). If a patient does not meet eligibility, answer “No” to each question and click Submit. By clicking Submit, the

ineligible patient will automatically be removed from the list of patients and another patient will auto-populate in the

patient list until you have 12 eligible patients total. Once it is determined that the patient is eligible and all three questions

are answered “Yes” in the Determination of Eligibility, the rest of the form will be accessible to enter data. Press the

“Save” button at the bottom of the screen to save your work.

Some facilities may not have 12 patients meeting eligibility criteria. In this case, all eligible patients will be shown on

the Prostate Patient List screen. If a patient does not meet eligibility, answer “No” to each question and click Submit. By

clicking Submit, the ineligible patient will automatically be removed from the list of patients. No additional patients will

auto-populate for these facilities having less than 12 patients meeting eligibility criteria.

The only way to go back to the previous screen/tab is by clicking on the “Back to Patient Selection” button at the bottom

(see arrow in the image below). The back button on the browser will not work.

Note that the web form will time out after 3 hours of inactivity.

Please make sure to save your work regularly.

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The NCDB Clinical Information Tab will auto-populate with data that has been entered for that patient and stored in the

NCDB warehouse. Please confirm that the data that had previously been submitted is correct. If it is not correct, enter the

updated corrected value.

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Clicking “Submit” (indicated by the black arrow below) after you have entered all required data automatically

submits the patient record to the NCDB. If you have not entered all required data or if you have entered data in an

incorrect format, you will not be able to submit the patient and will receive the error message shown below.

For the PSA, Testosterone, Scan, and Biopsy tabs, click the Add a New Test button to add PSA results, testosterone results,

imaging scans or biopsies performed in the surveillance period. Use the drop downs to enter data for the required fields

(dates, provider ordering the test, value of the test, etc).

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Once a patient’s information has been submitted, you will still be able to view the patient record by clicking on the

specific patient in your patient list. Submitted patients’ records are stored at the bottom of the page under the section

entitled “Patient data previously submitted” (see image below). If there are changes you need to make to the patient’s

record after it has been submitted, you will need to contact study staff by clicking on the “Contact” link to send an email

to the study team including the patient’s Study Specific Patient ID. The study team can then reset the record for you so

that you can make changes and resubmit the patient’s information. It is recommended to wait to submit cases, especially

if you are waiting on the arrival of external medical records.

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Please do not send any identifiable patient information over email or via this Contact link. This includes any date

(e.g. date of birth, date of surgery, date of chemotherapy, etc.), accession number, name, and medical record number. The

Study Specific Patient ID is a random number that will allow study staff to match the patient with the associated accession

number. Additionally, do not send the National Provider Identifier (NPI) or any information about a specific physician or

hospital.

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You can collapse the Patient Data section at the top of the page if you need more room by clicking on the vertical arrows

on the right (indicated by the black arrow below). If you do this, the accession number for each patient will still be shown

at the top of this section (indicated by the blue arrow below).

NOTE: Do not refresh the page or you will lose all data and be redirected to the login screen. Be sure to save your

work before closing or refreshing. The save button is located at the bottom of the screen and is indicated by the arrow in

the image below.

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At the top right of the screen, you will see the hospital with which you are working (indicated by the black arrow in the

image below). If you will be working with more than one hospital, this will be particularly helpful for you as you collect

the data.

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On the top of the screen there are two links to data collection instruction documents (see image below). These two links

include the same information that was mailed to you via email and US mail.

The “General Web Form Instructions” document gives you general information about the web form. The other document,

“Prostate Form Instructions,” is specific to the prostate study data collection elements. When you click on the link, a new

web page will open with a PDF of each document.

There are brief instructions under each tab (see below), but please refer to data abstraction instruction documents while

collecting data as they provide significantly more detailed information. This will increase the reliability of abstraction

across CoC facilities.

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Also on the top of the screen is a “Contact” link (indicated by black arrow in image above). Please use this link to email

study staff at the American College of Surgeons Clinical Research Program with any technical difficulties or questions

regarding data collection. Again, please do not send any identifiable patient or provider information over email or

via this Contact link. Use the Special Study Patient ID if your questions refer to a specific patient.

Once you click the “Contact” button, a separate page will open where you will be able to enter your name, email address,

subject of the message, and your question/comment. When you click “Submit,” your message will be sent to

[email protected] and you will be copied on the message. If you would prefer to email directly from your inbox,

send all emails to [email protected]. These e-mails will be directed to the study staff individuals who are familiar

with the data elements in this study. You can also call Eileen Tonner (312) 202-5685.

Please do not send questions to general NCDB staff, as they are not familiar with the data collection processes for

the special study. Study staff individuals are specifically trained to answer questions about these data items.



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Instructions for Prostate Study

Data Collection Instructions

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Determination of Eligibility

Rationale: These questions will help determine whether sufficient medical records are available for a selected

patient prior to a registrar starting the abstraction process. A patient must meet all criteria to be included in the

study. If a patient does not meet the screening criteria, please respond “No” to each of the following questions,

click “Submit” at the bottom of the screen, and move on to the next sampled patient. The ineligible patient will

be replaced with another patient in order to ensure 12 patients total are submitted per facility.

In the rare circumstance that your facility does not have 12 patients that meet the eligibility criteria, please enter

data for the patients shown on your list in the web form. If a patient does not meet eligibility, answer “No” to each

question and click Submit. By clicking Submit, the ineligible patient will automatically be removed from the list

of patients. No additional patients will auto-populate for these facilities having less than 12 patients meeting

eligibility criteria.

Is there evidence that medical records are available for this patient for at least 5 years from the time of the

surveillance start date or until distant recurrence or death (whichever is first)?

Please include patients who have records available or obtainable until distant recurrence (event) or death

(event), even if these events occur before 5 years.

Because prostate cancer is often a slow growing disease, it is necessary to abstract each patient’s medical

record information (including PSA tests, imaging, biopsy, recurrence, etc.) for at least 5 years from the

surveillance start date or until distant recurrence or death. If it is clear as you are reviewing medical

records that a patient has been lost to follow-up and that it is unlikely long-term records could be

obtained, please answer “No” to the eligibility questions, submit the patient, and move on to the next

patient.

Please note: the 5-year requirement for medical record availability is for eligibility criteria only and

separate from the 8-year surveillance period.

For patients who received primary radical prostatectomy, can you identify a patient’s urologist and primary care

physician involved in the patient’s care at the time of prostatectomy?

Or

For patients who received primary radiotherapy, can you identify the patient’s radiation oncologist and urologist

and primary care physician at the time of the radiotherapy?

Most prostate cancer patients after treatment receive surveillance (including PSA testing) from their

urologist, radiation oncologist (if radiation was part of the treatment), and/or primary care provider.

Therefore, the study will need to collect PSA tests and other records from all sources of follow-up care.

If it is impossible to identify who these providers/facilities are, please move on to the next patient.

Did the patient have at least 1 PSA test result in the first 2 years of the surveillance period and do you feel

confident about capturing PSA information for a minimum of 2 years at the beginning of the surveillance period?

PSA is the primary test used to monitor prostate cancer after primary treatment. The intent of this

screening question is to ensure that the registrar feels confident that for a particular patient, there is

sufficient and reliable PSA information that can be collected for this study.

Examples

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If a patient had a prostatectomy in 2006, had 2 PSAs drawn in the same year, and returns in 2008 with

elevated PSA (recurrence) after being lost to follow up for 2 years, he would be considered ineligible.

Even if it is documented that the patient was lost for part of the surveillance time period, but then

returned, the patient is ineligible since this is not a complete record. It is important to have confidence in

capturing the frequency of PSA checked after first treatment.

If there is no mention of a PCP in the available record from the urologist/radiation oncologist, the patient

is ineligible.

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Web Form Section: NCDB Clinical Information

Data Element: PSA at Diagnosis

Rationale: This section was created to confirm key clinical information located in the NCDB.

Note: recently there has been a systematic error noted in the SEER registries regarding PSA results. This is

due to the web entry form omitting the decimal point, which has caused confusion. For example, a patient

with PSA of 12.0 should be entered as “120” – but could be entered erroneously as “12” which actually

represents a PSA of 1.2. It is quite possible that such a systematic error could exist in the NCDB as well.

Variable to Confirm:

1. PSA at diagnosis (CS Site Specific Factor 1)

Guidelines for Data Collection:

Please consult the patient’s medical record (not the hospital registry database) to confirm that the data in the

NCDB for each selected patient (as entered into the “NCDB Clinical Information” section) is correct.

Collect this field in a manner consistent with the FORDS manual NAACCR item referenced.

1. If the information provided in the web form is correct, please verify by selecting the ‘Yes’ option.

2. If you find that the information is incorrect, please select the ‘No’ option and record the correct value

in the field provided.

Additional Information: If values need to be updated, this information will also need to be updated in your

registry database so that it can be corrected at the next time of data collection for the NCDB Call for Data.

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Data Element: Primary Biopsy Gleason Score

Data Element: Secondary Biopsy Gleason Score

Rationale: This section was created to confirm the aggressiveness of the prostate cancer, which is critical for this

project. It is also important to distinguish biopsy vs. prostatectomy/surgery Gleason scores ensuring there are no

errors in data submitted to the NCDB.

Variables to Confirm:

1. Primary Biopsy Gleason Score (NAACCR Item Number #2920)

2. Secondary Biopsy Gleason Score (NAACCR Item Number #2920)


Please consult the patient’s medical record (not the hospital registry data) to confirm that the data are correct in

the NCDB for each selected patient (as entered into the “NCDB Clinical Information” section).

Collect these fields in a manner consistent with the FORDS manual NAACCR item referenced.


2. If you find that the information is incorrect, please select the ‘No’ option, and record the correct value

in the field provided using the drop down menu. The response categories included in the drop-down

box reflect values from the FORDS manual and should be collected accordingly.


registry database to be corrected at the next time of data collection for the Call for Data.

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Data Element: Prostatectomy Gleason Score (Primary)

Data Element: Prostatectomy Gleason Score (Secondary)

Data Element: Prostatectomy Gleason Score (Tertiary), if reported

*Note: these data elements are only reported if patient received radical prostatectomy as

their first treatment.

Rationale: This section was created to confirm the aggressiveness of the prostate cancer, which is critical for this

project. It is important to distinguish biopsy vs. prostatectomy Gleason scores to ensure reliability of abstraction

in data submitted to the NCDB.

Variables to Confirm or Enter:

1. Primary Prostatectomy Gleason Score (NAACCR Item Number #2863)

2. Secondary Prostatectomy Gleason Score (NAACCR Item Number #2864)

3. Tertiary Prostatectomy Gleason Score (NAACCR Item Number #2865)



the NCDB for each selected patient (as entered into the “NCDB Clinical Information” section).








Note: Prostatectomy Gleason Score was not a required field in the NCDB until 2010. If these fields are

empty on the web form but the data is included on the pathology report, please select “No” in the

“Information in NCDB Confirmed Correct” column and enter the data elements accordingly.

Note: Tertiary Gleason score can be missing/not reported on pathology reports. If this is the case, please leave the

first column blank and select the “Yes” option. This will indicate the Tertiary Gleason score is missing/not

reported.

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Data Element: Clinical N Stage

Rationale: This section was created to confirm clinical staging of the prostate cancer.


1. Clinical N Stage (NAACCR Item #950)



the NCDB for each of the selected patients (as entered into the “NCDB Clinical Information” section).








Note: If the value currently in the NCDB is “T2” and you are able to find more detailed information (e.g. T2a),

please make this update.

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Data Element: Pathologic T Stage

Data Element: Pathologic N Stage

*Only relevant for patients who received first treatment = radical prostatectomy.

Rationale: This section was created to confirm pathologic staging of the prostate cancer.


1. Pathologic T Stage (NAACCR Item #880)

2. Pathologic N Stage (NAACCR Item #890)











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Data Element: Receipt of Radiation Treatment (External Beam and/or Brachytherapy)

Rationale: This field is being abstracted to confirm key first course treatment elements.


1. Receipt of Radiation (NAAACR Item Number #1360)




Collect fields in a manner consistent with the FORDS manual NAACCR item referenced.






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Data Element: Radiation Start Date

Data Element: Radiation End Date



1. Radiation Start Date (NAACCR Item Number #1210)

2. Radiation End Date (NAACCR Item Number #3220)





2. If you find that the information is incorrect, please select the ‘No’ option, and follow the directions below to

record the correct value in the field provided.

Recording Dates in the Web form:

Please note: The Radiation Start Date and Radiation End Date that are shown in this section have been

taken directly from the NCDB warehouse. However, should you need to update any dates in the “Correct

Value” column, please follow the date guidelines for the special study, as specified below.

Record as YYYYMMDD where MM is two-digit month, DD is two-digit day, and YYYY is four-digit

year (example: June 15, 2007 = 20070615).

If only month and year is known, enter as YYYYMM99 (example: June, 2007 = 20070699).

If only the year when the patient underwent radiation therapy is known enter as YYYY9999 (example

2007: 20079999).

Enter “99999999” if it is known that a patient underwent radiation, but the date is completely unknown.

Enter “77777777” if it is unknown if a patient underwent radiation.

Enter “00000000” if it is known that no radiation was performed.

Note: 99999999 is entered in the first column if it is unknown whether a patient underwent radiation therapy.

Please update this field according to the guidelines above.



NCDB Call for Data Note: When you update these date fields in your registry software, the dates will be in the

interoperable format, which may be CCYYMMDD, and every date field has an associated date field flag.

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Additionally, in the vendor software unknown date fields are left blank instead of being shown as 99999999. You

will need to adjust the entry format when updating these fields in your registry software.

Note: The time period between radiation start date and radiation end date must be <180 days.

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Data Element: Receipt of Hormone Therapy (aka Androgen Deprivation Therapy)



1. Receipt of Hormone Therapy (NAACCR Item #2880)










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Data Element: Start date of Hormone Therapy (aka Androgen Deprivation Therapy)



1. Start Date of Hormone Therapy (NAACCR Item #2890)





2. If you find that the information is incorrect, please select the ‘No’ option, and follow the directions below to

record the correct value in the field provided.

Recording Dates in the Web form:

Please note: The Hormone Therapy Start Date that is shown in this section has been taken directly from the NCDB

warehouse. However, should you need to update any dates in the “Correct Value” column, please follow the date

guidelines for the special study, as specified below.

Record as YYYYMMDD where MM is two-digit month, DD is two-digit day, and YYYY is four-digit

year (example: June 15, 2007 = 20070615).


If only the year when the patient underwent radiation therapy is known enter as YYYY9999 (example

2007: 20079999).

Enter “99999999” if it is known that a patient underwent hormone therapy, but the date is completely

unknown.

Enter “77777777” if it is unknown if a patient underwent hormone therapy.

Enter “00000000” if it is known that no hormone therapy was performed.

Note: 99999999 is entered in the first column if it is unknown whether a patient underwent hormone therapy.

Please update this field according to the guidelines above.



NCDB Call for Data Note: When you update these date fields in your registry software, the dates will be in the

interoperable format, which may be CCYYMMDD, and every date field has an associated date field flag.

Additionally, in the vendor software unknown date fields are left blank instead of being shown as 99999999. You

will need to adjust the entry format when updating these fields in your registry software.

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Data Element: Receipt of Other Therapy



1. Receipt of Other Therapy (NAACCR Item Number #1420)



the NCDB for each of these patients (as entered into the “NCDB Clinical Information” section).








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Data Element: Date of Last Contact or Death

Data Element: Vital Status

Rationale: This section was created to confirm and/or update key clinical information located in the NCDB.


1. Date of Last Contact or Death (NAACCR Item #1750)

2. Vital Status (NAACCR Item #1760)


Please consult the patient’s medical record (not the hospital registry database) to confirm that the data in the

NCDB for each patient (as entered into the “NCDB Clinical Information” section) are correct.



2. If you find that the information is incorrect, please select the ‘No’ option and record the correct value


box reflect values from the FORDS manual and should be selected accordingly.


registry database so that it can be corrected at the next time of data collection for the NCDB Call for Data.

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Web Form Section: Comorbidities

Data Element: Comorbidities

Definition: Patients with cancer often have other chronic conditions in addition to their diagnosed cancer that can

impact long-term health. These conditions are referred to as “comorbidities.”

Rationale: The web form contains a list of chronic conditions (“comorbidities”) that prior research has shown to

be associated with increased mortality risk among patients with cancer. We are specifically looking for chronic

conditions that a patient had around the time of the treatment date.

High Yield Locations in Medical Record

Because we are looking for chronic conditions a patient had around the time of a patient’s first treatment

for their prostate cancer (as recorded in “patient data” section), high yield locations in the medical record

would include:

Pre-treatment history and physical (at the time of first surgery or first radiotherapy for the initial

cancer)

Pre-treatment anesthesia report (at the time of first surgery of first radiotherapy for the initial

cancer)

Notes from clinic or consult visits (include primary care provider (PCP/APP); radiation

oncologist; urologist; other provider)

Allowable Values

Check the boxes corresponding to each condition or indicate whether none of the referenced

comorbidities are included in the high yield locations in the medical record within 30 days before and

up to 90 days after the start of first treatment. Please check all conditions that apply to the selected

patient.

If relevant records are not included in the medical record, it is very important that you check

“Comorbidity Information Not Available in the Medical Record.” This allows investigators/NCDB staff

to differentiate “no comorbidities” from “no information available.”

Guidelines for Data Collection

Select all conditions that are included in any of the high yield locations in the medical record listed above

within 30 days before and up to 90 days after the patient’s start of first treatment.

If relevant records are missing from the medical record, please check the box next to “Comorbidity

Information Not Available in the Medical Record.”

If none of the referenced comorbidities below are included in medical record, please check the box next to

“None of the Below Comorbidities Listed in the Medical Record.”

The instructions for collecting each of the identified conditions are included below.

Whatever the source of your information, make sure the comorbidities are present within 30 days before

and up to 90 days after the patient’s start of first treatment.

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Terms that constitute a diagnosis of a comorbid ailment:

o Compatible with

o Probable

o Consistent with

o Suspect

o Most likely

o Suspicious

o Presumably

Terms that do not constitute a diagnosis of comorbid ailment:

o Equivocal

o Suggests

o Possible

o Worrisome

o Questionable

o Rule Out

o “Claims to be"

Chronic Conditions

o Coronary Artery Disease Myocardial infarction (MI), Non-ST Elevation MI [NSTEMI], Acute MI [AMI], Acute

ST Elevation MI [ASTEMI], Demand MI, ‘Troponin Leak,’ Unstable Angina, CAD,

Coronary Artery Disease

o Congestive Heart Failure CHF, Cardiomyopathy [ICM, CM])

o Peripheral Vascular Disease PVD, Claudication, Peripheral Arterial Disease [PAD], Arterial Atherosclerosis, Aortic

Aneurysm [AAA], Arterial Embolism

o Cerebrovascular Vascular Disease CVD, Stroke, Transient Ischemic Attack [TIA], Subarachnoid Hemorrhage, Intracerebral

Hemorrhage

o Hemiplegia/Paraplegia Spinal Cord Injury, Hemiparesis from Stroke

o Chronic Pulmonary Disease COPD, Chronic Bronchitis, Emphysema, Asthma, Asbestosis, Restrictive Lung Disease,

Interstitial Lung Disease

o Dementia includes patients with chronic cognitive deficit

o Other Neurologic Conditions Parkinson’s Disease; Uncontrolled Seizures, or Syncope without identified

cause/treatment

o Diabetes End-Organ Damage Present Chronic Renal/Kidney Disease, Nephropathy, Neuropathy, Retinopathy

o Diabetes Type 1, Type 2, Insulin Dependent

o Moderate or Severe Renal Disease Hemodialysis, End-Stage Renal Disease [ESRD], Peritoneal Dialysis, Chronic Kidney

Disease, Glomerulosclerosis, Glomerulonephritis, Acute Renal Failure

o Moderate/Severe Liver Disease

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Acute Viral Hepatitis, Acute Liver Necrosis, Acute Hepatic Failure, Liver Abscess,

Cirrhosis WITH Complications

o Mild Liver Disease Cirrhosis WITHOUT Complications, Cystic Liver Disease, Hepatomegaly, Fatty Liver

o Gastrointestinal Ulcer Disease Peptic Ulcer, Duodenal Ulcer, Gastric Ulcer, Esophageal Ulcer

o Connective Tissue Disease Rheumatologic Disease, Rheumatoid Arthritis [RA], Lupus [SLE], Gout [CPD, CPPD],

Polymyalgia Rheumatica

o Psychiatric Depressed mood/state; Adjustment Disorder, Dysthymia, Suicide Attempt, Active

Schizophrenia, Bipolar Disorder

o Substance Abuse

Includes alcoholism (i.e., delirium tremens, history of or active alcohol abuse even if not

presently drinking) and illicit drugs (i.e., acute withdrawal syndrome, history of or active

substance abuse)

Note: substance abuse does not include tobacco use.

o Height (inches)

Enter “999” if height is missing

o Weight (pounds)

Note: as with other comorbidities, please capture weight within 30 days before and up to

90 days after the patient’s start of first treatment.

Enter “999” if weight is missing

35


Web Form Section: Additional Clinical Information

Information Found on the Biopsy Pathology Report:

This information should be abstracted for all sampled patients.

Number of cores taken on initial biopsy (initial diagnosis) This information comes from the biopsy pathology report that is dated closest to the date of diagnosis.

Please count/sum the total number of cores from all the regions of the prostate.

Common result: around 6 or 12. Expected range of results: 1 to 30.

If information is missing, enter “999”

Number of cores which contain cancer diagnosis (with a Gleason score given) This information should be included in the biopsy pathology report as referenced above.

Please count/sum the total number of cores with cancer (a Gleason score is given). Do not count the cores

that do not have an accompanying Gleason score.

This number cannot be greater than the number of cores taken on initial biopsy.

If information is missing, enter “999”

36


Web Form Section: Additional Clinical Information

Data Element: If the patient received hormone therapy as part of primary treatment,

what was the intended total duration of hormone therapy?

Definition: Hormone therapy could be used along with primary radical prostatectomy or primary radiation

treatment.

Rationale: If the patient received hormone therapy along with primary radical prostatectomy or primary radiation

treatment, the hormone therapy can affect subsequent PSA results and assessment of recurrence. Therefore,

knowing the intended total duration of hormone therapy is important.


Notes from clinic or consult visits (include radiation oncologist; urologist; medical oncologist) from date

of diagnosis through 1 year after primary treatment end date.

Allowable Values

Number of months of intended hormone therapy (commonly between 3-36 months)

0 if no hormone therapy was given along with primary radical prostatectomy or primary radiation

999 if hormone therapy was given but duration was unknown


Please look in physician notes to record the intended duration of hormone therapy.

This should be entered as the number of months intended for hormone therapy.

37


Information Found on the Radical Prostatectomy Pathology Report:

Did the Patient have Radical Prostatectomy as Primary Treatment? Yes/No

o If No, the following fields will disable on this “Additional Clinical Information” page. Please

save and continue.

This information should be abstracted only for patients who had primary radical

prostatectomy.

If the patient had radical prostatectomy as first treatment: how many lymph nodes total

were reported in the surgical pathology report? This information comes from the pathology report from radical prostatectomy (date of this pathology

report should be the same as the date of radical prostatectomy or very close to it). This is different than

the biopsy pathology report above.

Please count/sum the total number of nodes reported on the entire pathology report from all nodal regions.

Expected range of results: 0 to 60.

If unknown, enter 999.

If the patient had radical prostatectomy as first treatment: how many lymph nodes

contained cancer in the surgical pathology report? This information comes from the pathology report from radical prostatectomy (date of this pathology

report should be the same as the date of radical prostatectomy or very close to it).

Please count/sum the total number of nodes containing cancer on the entire pathology report from all

nodal regions.

Expected range of results: 0 to 60.


Note: This number should not be larger than the previous answer to “If the patient had radical

prostatectomy as first treatment: how many lymph nodes total were reported in the surgical pathology

report?”

If the patient had radical prostatectomy as first treatment: was there “perineural invasion”

on the surgical pathology report? Please examine the radical prostatectomy pathology report for indications of these features


If patient had radical prostatectomy as first treatment: was there “lymphovascular

invasion” (also called LVI, angiolymphatic invasion) on the surgical pathology report? Please examine the radical prostatectomy pathology report for indications of these features


If the patient had radical prostatectomy as first treatment: was any surgical margin

positive on the surgical pathology report? Please examine the radical prostatectomy pathology report for indications of positive surgical margin(s)

If any surgical margin was positive, please record “yes” for this question

38


If the pathology indicates that margin is “close,” please record “no.” (close margin = negative margin)


If the patient had radical prostatectomy as first treatment: was there seminal vesicle

involvement with cancer on the surgical pathology report? Tumor has invaded either one or both seminal vesicle

This is the same as pT3b stage


If the patient had radical prostatectomy as first treatment: was there extracapsular

extension or invasion beyond the capsule (i.e. T3a stage) on the surgical pathology

report? Tumor extended through the prostate capsule (one side or both sides)

This is the same as pT3a stage

o Unless there is also simultaneous seminal vesicle invasion; in that case pT3b stage trumps


39


Web Form Section: Surveillance Data

Data Element: What is the NPI of the urologist?

Data Element: What is the NPI of the radiaton oncologist?

Data Element: What is the NPI of the medical oncologist?

Data Element: What is the NPI of the primary care provider?

Definition: Physicians involved in the patient’s prostate cancer treatment and/or monitoring. Primary care

provider could be nurse practitioner or physician assistant.

Rationale: These are the providers most likely to be involved in doing prostate cancer monitoring after primary

treatment, and patient medical records will be needed from these providers for this study.

Guidelines for Data Collection: It is possible that each patient may have more than one urologist, more than one radiation oncologist,

more than one medical oncologist, and/or more than one primary care provider. NPI is needed for all of

these providers involved in the care of patients throughout the surveillance period.

Primary care includes geriatricians, family physicians, and internal medicine physicians. Primary care

provider could also be nurse practitioner or physician assistant.

40


Web Form Section: PSA

Data Element: Date PSA Test Performed

Definition: Prostate specific antigen (PSA) blood test is the primary test used to monitor patients for recurrence

after primary treatment. Please record PSA performed during the surveillance period (8 years starting from the

surveillance start date or until the time of distant recurrence or death, whichever comes first).

Rationale: The number and timing of PSA tests performed is a primary question being asked by this study. The

PSA result is how prostate cancer recurrence is most commonly defined.


Laboratory values (your institution and correspondence with outside institutions), from the urologist,

radiation oncologist, medical oncologist, and primary care provider.

Notes from clinic and consult visits (include primary care provider (PCP/APP); medical oncologist;

radiation oncologist; urologist; other providers).

Allowable Values:

YYYYMMDD

00000000 if no PSA tests were performed

99999999 if a PSA test was performed, but the date is completely unknown

77777777 if it is unknown whether a PSA test was performed


Enter the date corresponding with each of the PSA tests performed.

It is likely for patients to have 4 or more PSA tests during each year.

Recording Dates

o Record as YYYYMMDD where MM is two-digit month, DD is two-digit day, and YYYY is

four-digit year (example: June 15, 2007 = 20070615).

o If only month and year is known, enter as YYYYMM99 (example: June, 2007 = 20070699).

o If only the year when the PSA test was performed is known enter as YYYY9999 (example 2007:

20079999).

Enter “99999999” if it is known that a PSA test was performed, but the date of the test is completely

unknown.

41



Data Element: Who Ordered PSA


after primary treatment. Please record the specialty of the provider who ordered the PSA performed during the

surveillance period (8 years starting from the surveillance start date or until the time of distant recurrence or

death, whichever comes first).

Rationale: Knowing which provider ordered the PSA will be important when studying practice patterns around

recurrence.





radiation oncologist; urologist; other providers)

Allowable Values:

U= urologist

R = radiation oncology

M = medical oncology

P = primary care

O=others


If it is unknown who ordered the PSA, please code (U, R, M, P, O) based on which physician office the

PSA result information was obtained/abstracted.

Examples of “other” specialties include cardiology, emergency medicine, etc.

42



Data Element: PSA Result


after primary treatment. Please record PSA performed during the surveillance period (8 years starting from the

surveillance start date or until the time of local/regional/distant recurrence, new primary cancer diagnosis or

death, whichever comes first).

Rationale: The number of PSA tests performed is the primary question being asked by this study. The PSA result

is how prostate cancer recurrence is most commonly defined. This information is critically important for this

study.





radiation oncologist; urologist; other providers)

Allowable Values:

PSA result will be entered per FORDS standards, using the unit ng/mL. For example:

If PSA result is 12.0 enter 120




If PSA result is <0.1 or <0,01 enter 0

If a PSA was checked but the exact value is unknown, please enter:

E: elevated, actual value unknown

N: normal, actual value unknown

X: no known information about the value of the PSA

Note: recently there has been a systematic error noted in the SEER registries regarding PSA results, due to

the web entry form omitting the decimal point, causing confusion. For example, a patient with PSA of 12.0

should be entered as “120” – but could be entered erroneously as “12,” which actually represents a PSA of

1.2. It is quite possible that such a systematic error could also exist in the NCDB.

43



Data Element: Is the Patient on Hormone Therapy at the Time of the PSA Test?

Definition: Hormone therapy could be used along with primary radical prostatectomy or primary radiation

treatment, or for treatment of prostate cancer recurrence.

Rationale: Hormone therapy can affect PSA results and assessment of recurrence.



radiation oncologist; urologist; other provider)

Allowable Values (is the patient on hormone therapy at the time of this PSA test?)

1. Yes: indicate “yes” if hormone therapy was given within 180 days prior to the date of this PSA test

2. No

3. Unknown


Please answer yes/no or unknown corresponding to each PSA date

44



Data Element: How confident are you that all medical records related to PSA

for this patient are available for you to review? Definition and Rationale: These fields will provide an opportunity for registrars to communicate with

investigators about the completeness of the medical record for the assessment of PSA tests for the selected

patient. This information is vital for the determination of whether or not comprehensive information is collected

about the PSA tests performed following cancer treatment.

Allowable Values

0-100% confidence that all medical record information related to PSA tests is available for the selected

patient during the surveillance period for review.

45


Web Form Section: Testosterone

Data Element: Date of Total Testosterone Test

Data Element: Testosterone Result

Definition: Please abstract each total testosterone test that is performed during the surveillance period (8 years

starting from the surveillance start date or until the time of distant recurrence or death, whichever comes first).

Do not record “free testosterone” or “bioavailable testosterone”

Rationale: Some physicians routinely check testosterone levels in prostate cancer patients as part of monitoring

after primary treatment. Low testosterone level can affect subsequent PSA results and assessment of recurrence.






Allowable Values (date total testosterone test performed)

YYYYMMDD

00000000 if no testosterone tests were performed

99999999 if a testosterone test was performed, but the date is completely unknown

77777777 if it is unknown whether a testosterone test was performed


Enter the date corresponding with each of the total testosterone tests performed for a period of 8 years

between the surveillance start date and the time of a local/regional/distant recurrence, new primary cancer

diagnosis or death (whichever comes first).

Recording Dates



o If only month and year is known, enter as YYYYMMDD (example: June, 2007 = 20070699).

o If only the year when the total testosterone test was performed is known enter as YYYY9999

(example 2007: 20079999).

Enter “99999999” if it is known that a total testosterone test was performed, but the date of the test is

completely unknown.

If there is no indication of testosterone tests in the patient’s record, enter Add New Test and use the

following coding instructions as necessary:

o Enter 77777777 if it is truly unknown whether a testosterone test was performed.

o Enter 00000000 if it is known that no testosterone tests were performed.

Allowable Values (total testosterone result)

Total testosterone result will be entered using the unit ng/mL. Please enter a whole number (no decimal).

Normal level of total testosterone is 250-1100.

46


Web Form Section: Scan

General Coding Principles

The collection of follow-up information, including imaging study data, is vital to the success of this study.

Registrars will likely need to go outside their institution to other providers or hospitals for

information pertaining to health care utilization and health outcomes for patients. The CoC has

provided a letter template for this study that can be utilized to contact these providers for patient

information.

Please collect information relating to imaging studies performed beginning on the surveillance start date

(indicated at the top of the web form in the “patient data” section as shown in the picture below) for a

period of 8 years or until the date of a patient's first distant recurrence or death, whichever comes first.

This information is critical for a comprehensive assessment of follow-up studies and how they may

influence the detection of new prostate cancer events (local/regional/distant recurrence or new primary

cancer). Please collect each data element according to the Special Study Data Collection Guidelines that

follow.

For each imaging study, enter the date the study was performed, the type of scan, the indication for study,

the result of scan, additional imaging recommended, and biopsy recommended according to the

instructions detailed below.

Imaging information should continue to be abstracted for a period of 8 years starting from the time of the

surveillance start date until the time of a documented distant recurrence or death (whichever is first).

Surveillance Start Date

47


Selecting “Add a New Test” (see image below) adds an additional row for each study performed. Scans

do not need to be added in the order of occurrence. If you find a test that was missed, you can add it even

if it is not in chronological order by time.

For more space, click on the vertical arrows (see black arrow in image below) to collapse the instructions.

If an imaging study is added in error, selecting the “delete” button will remove the row associated with

the extra imaging study (see above). You must delete any unused rows or rows with incomplete data

prior to submitting the patient’s data, or you will get an error message when trying to submit the patient’s

information.

48


If it is not clear how to collect the indication or result of a particular imaging study, please click the

“Contact” link (indicated by black arrow below) so the investigator and the study staff individuals

can provide clarification and feedback.

49



An imaging study is defined as performed scans (CT, MRI, PET or PET/CT, bone scan, ultrasound, X-

ray) no later than 8 years from the time of the surveillance start date until the time of distant recurrence or

death (whichever is first). This could be performed as routine screening/follow-up to primary prostate

cancer treatment, as a follow-up to new signs/symptoms of recurrence, follow up of elevated PSA tests, or

for non-cancer related issues.

Examples of recurrence signs/symptoms include but are not limited to:

Worsening back, bone, or joint pain

Numbness/weakness in part of body

Physical exam by the physician indicating possible recurrence (e.g. prostate nodule)

Please note: Imaging scans do not need to be entered in chronological order.

Dates can be entered in YYYYMMDD format.

If there is no indication of imaging in the patient’s record, enter Add New Test and use the following

coding instructions as necessary:

o Enter 77777777 if it is truly unknown if a scan was performed.

o Enter 00000000 if it is known that no scans were performed.

50



Data Element: Date of Scan

Definition: Date when imaging study was performed.

Rationale: This field will allow for further understanding of the timing of imaging studies and the detection of

prostate cancer recurrence.

Suggested High Yield Locations in Medical Record

Radiology/Imaging Reports (at your institution or correspondence from other institutions)



Allowable Values

YYYYMMDD

00000000 if no imaging studies were performed

99999999 if an imaging study was performed, but the date is completely unknown

77777777 if it is unknown whether an imaging study was performed


Enter the date corresponding with each of the imaging studies that are performed for a period of 8 years

between the surveillance start date and the time of a distant recurrence or death (whichever comes first).

Please include imaging studies that may have been done for other reasons. We have included an

indication for study that reflects imaging studies that are not cancer related for this purpose.

Recording Dates



o If only month and year when the study was performed is known, enter as YYYYMMDD

(example: June, 2007 = 20070699).

o If only year when study was performed is known, enter as YYYY9999 (example: 2007 =

20079999).

Enter “00000000” if it is known that no scans were performed.

Enter “99999999” if it is known that an imaging study was performed but the complete date is completely

unknown.

Enter “77777777” if it is unknown whether an imaging study was performed.

Relevant imaging studies include:

o Abdomen/Pelvis CT

o Abdomen/Pelvis MRI

o Chest CT or MRI

o PET or PET/CT (any type of PET scan, any location)

o Bone scan

o Ultrasound

o X-ray

o Other

51



Data Element: Type of Scan

Definition: Type of imaging study performed during the surveillance period.

Rationale: This field will allow for further understanding of the type and timing of imaging studies and the

detection of prostate cancer recurrence.





Allowable Values

1. Abdomen/Pelvis CT

2. Abdomen/Pelvis MRI

3. Chest CT or MRI

4. PET or PET/CT (any type of PET scan, any location)

5. Bone scan

6. Ultrasound

7. X-ray

8. Other


Please include imaging studies that may have been done for other reasons. We have included an

indication for study that reflects imaging studies that are not cancer related for this purpose.

A CT-Chest/Abdomen/Pelvis should be coded as separate tests (Chest CT and Abdomen/Pelvis CT)

52



Data Element: Indication for Study

Definition: Indication for ordering each imaging study during the surveillance period.

Rationale: This field will allow for further understanding of surveillance imaging by seeking to identify why a

particular imaging study was performed. Our goal is to determine whether the patient had symptoms that led to

the study or whether the study was routinely ordered regardless of whether not the patient was symptomatic.

If after reading the instructions it is not clear how to collect the indication of a particular imaging study,

please click the “Contact” link on the web form so investigators and study staff members can provide

clarification and feedback.


Primary: Radiology/Imaging Reports (at your institution or correspondence from other institutions).

Secondary: Notes from clinic and consult visits (include primary care provider (PCP/APP); medical

oncologist; radiation oncologist; urologist; other provider)

Please pay particular attention to reminders for scheduling during clinic visits (for example: a study that

was performed as a result of an instruction in the clinic notes to “schedule scan/study and visit within 6

months” would be considered surveillance imaging in absence of new sign/symptom).

Allowable Values:

1. Surveillance imaging in absence of new sign/symptom (asymptomatic)

2. Follow up of abnormal or rising PSA

3. Follow up for patient-reported new sign/symptom

4. Follow up of new physical exam finding by physician/practitioner

5. Immediate follow-up (1 month or less) for suspicious finding on other imaging

6. Short interval follow-up (greater than 1, less than 6 months) for suspicious finding on imaging

7. Other/unrelated to prostate cancer

8. Unable to determine


We suggest you start by looking at the Radiology/Imaging Reports (at your institution or correspondence

from other institutions) and identifying the listed indication for the study.

If the indication shows “routine” or “personal history of prostate cancer” or other non-specific indication,

review clinic notes to determine if this is a routine scan by making sure it was not ordered because of a new

sign or symptom and select “1.”

If the indication shows “suspected prostate cancer recurrence” or “elevated PSA,” please review clinical notes

and PSA results to confirm and select “2.”

If the indication includes symptoms (see site-specific list of symptoms below), confirm new symptoms are

present by reviewing clinic notes (include primary care provider (PCP/APP); medical oncology; radiation

oncology; urology; other provider) if available and select “3.”

53


Possible signs or symptoms for response “3”: o Pain in back or bones/joints

o Numbness/weakness in part of body

o Shortness of breath or pain with breathing

o Headache, mental status changes, or other new neurologic changes

o Fatigue

o Unexplained weight loss

If the indication is “suspected prostate cancer recurrence,” please review clinical notes to confirm if there was

a physical exam finding which led to suspected recurrence. If so, select “4.”

If the indication is “follow-up for suspicious finding on other imaging” or similar, look at previous imaging

reports and confirm there was an abnormality seen and confirm in the clinic notes that this was the reason for

the study.

o If immediate follow-up (within 1 month after suspicious finding on prior imaging), select “5”

o If short interval follow-up (after 1 month and less than 6 months after suspicious finding on prior

imaging), select “6”

o Examples:

Pulmonary nodule found on imaging with recommendation to follow-up with chest CT in

6 months.

Vertebral fracture or rib fracture seen on chest x-ray with bone scan recommended.

If the indication does not appear to be cancer related, select “7.” Examples include trauma, diverticulitis, etc.

Select “8” if there is no information regarding the intention of the imaging study in the medical record.

54



Data Element: Result of Scan

Definition: Results from each imaging study.

Rationale: This field will allow for further understanding of surveillance by identifying the results of performed

studies.

If after reading the instructions it is not clear how to collect the result of a particular imaging study, please

click the “Contact” link on the web form so investigators and study staff members can provide clarification

and feedback. Imaging information is particularly critical for this study.





Allowable Values:

1. Negative/benign

2. New finding - Indeterminate

3. New finding – Suspicious or consistent with locoregional recurrence

4. New finding – Suspicious or consistent with distant recurrence

5. Unable to determine


Select “1” if there are no findings on imaging to indicate a local/regional or distant recurrence or a new

prostate cancer.

o This category includes:

Study was done, results were normal.

Study was done and the medical record specifies the result was abnormal, but not cancer

related (e.g., hernia, liver hemangioma, stable pulmonary nodules).

Select “2” if there is an indeterminate finding whereby malignancy cannot be ruled out.

o Examples of an indeterminate finding include: pulmonary nodule or liver lesion for which

interval follow-up imaging was recommended.

Select “3” if there is a finding that is suspicious for malignancy.

o Local recurrence includes: prostate, seminal vesicles, bladder, rectum

o A scan which shows recurrence in the prostate bed should be coded as local recurrence.

o Regional recurrence includes: nodes of the true pelvis, which essentially are the pelvic nodes

below the bifurcation of the common iliac arteries. They include the following groups: pelvic

NOS, hypogastric, obturator, iliac (internal, external, NOS), sacral (lateral, presacral, promontory

[Gerota’s] or NOS)

Select “4” if there is a finding that is suspicious for malignancy.

o Distant recurrence is any recurrence outside local and outside regional, e.g. bone (most common),

lung, liver.

Select “5” if the medical record indicates that the test was done but it is not possible to find information

on the test result in the medical record.

Please do not go back and change the indication of the study based on findings from the imaging study.

55



Data Element: Follow-up/Additional Imaging Recommended?

Definition: Please look at the radiology/imaging report and the clinic visit notes to see if further imaging is

recommended (either immediately or a few months later) to further assess finding(s) of the current scan.

Rationale: This field will allow for further understanding of downstream consequences of imaging studies which

may lead to more imaging studies.





Allowable Values:

1. No additional imaging was recommended

2. Immediate follow-up with additional imaging (within 1 month)

3. Short-interval follow-up (greater than 1 month, less than 6 months)

4. Unknown

56



Data Element: Biopsy Recommended?

Definition: Please look at the radiology/imaging report and the clinic visit notes to see if biopsy is recommended

to further assess finding(s) of the current scan (suspected recurrence or new cancer).

Rationale: This field will allow for further understanding of downstream consequences of imaging studies which

may lead to more tests (biopsies)



Pathology reports (at your institution or correspondence from other institutions)



Allowable Values:

1. Yes

2. No

3. Unknown

57



Data Element: How confident are you that all medical records related to

imaging for this patient are available for you to review? Definition and Rationale: These fields will provide an opportunity for registrars to communicate with

investigators about the completeness of the medical record for the assessment of imaging studies for the selected

patient. This information is vital for the determination of whether or not comprehensive information is collected

about the imaging studies performed following cancer treatment.

Allowable Values

0-100% confidence that all medical record information related to imaging studies is available for the

selected patient during the surveillance period for review.

58


Web Form Section: Biopsy


For each biopsy observed in the medical record from the time of the surveillance start date for a period of

8 years or until the time of a distant recurrence or death (whichever comes first), please enter the date the

biopsy was performed, the site of the biopsy, the indication for biopsy, and the result of the biopsy.

Selecting “Add a New Test” (see below) will add an additional row that allows for the information

referenced above to be collected for each biopsy.

If you add a new biopsy in error, selecting the “Delete” button will remove the row associated with the

biopsy entered in error (see below). Biopsies do not need to be added in chronological order.

If there is no indication of a biopsy in the patient’s record, enter Add New Test and use the following

coding instructions as necessary:

o Enter 77777777 if it is truly unknown if a biopsy was performed.

o Enter 00000000 if it is known that no biopsy was performed.

59



Data Element: Date of Biopsy

Definition: Date associated with all performed biopsies from the time of the surveillance start date for a period of

8 years or until the time of a distant recurrence or death (whichever comes first).

Rationale: This field will allow for further understanding of the consequence of PSA and imaging tests and the

detection of new prostate cancer events and distant recurrence.


Pathology Reports (at your institution or correspondence from other institutions)

Radiology Reports (at your institution or correspondence from other institutions)

Operative Reports (at your institution or correspondence from other institutions)



Allowable Values

YYYYMMDD

00000000 if no biopsy was performed

99999999 if it is known that a biopsy was performed, but the date is completely unknown

77777777 if it is unknown whether a biopsy was performed


Enter the date corresponding with each biopsy performed

Recording Dates



o If only month and year of the biopsy is known, enter as YYYYMM99 (example: June, 2007 =

20070699).

o If only year of the biopsy is known, enter as YYYY9999 (example: 2007 = 20079999).

Enter “99999999” if it is known that a biopsy was performed but the date is completely unknown.

Enter “77777777” if it is unknown if a biopsy was performed.

Enter 00000000 if it is known that no biopsies were performed.

60



Data Element: Indication for Biopsy

Definition: The reason for performing the biopsy.

Rationale: To differentiate whether the biopsy was performed to assess a suspected cancer recurrence, or for a

non-cancer reason.

Suggested High Yield Locations in Medical Record for Information






Allowable Values

1. Suspect cancer (either prostate cancer recurrence or new cancer)

2. Not cancer related

3. Unknown


Please review the clinical notes around the time of the biopsy to determine whether the indication is

cancer related (Select #1) or not cancer related (Select #2).

61



Data Element: Location of Biopsy

Definition: Identify the site of performed biopsies.

Rationale: Collection of information related to site of biopsy/biopsies allows for an assessment of consequences

associated with post-treatment surveillance PSA and imaging testing.

Suggested High Yield Locations in Medical Record for Information:






Allowable Values:

1. Prostate (if patient never had prostatectomy)

2. Prostate bed (if patient had prostatectomy)

3. Regional nodes

4. Other lymph nodes (non-regional)

5. Bone

6. Liver

7. Lung

8. Brain

9. Other


Regional nodes are nodes of the true pelvis, which essentially are the pelvic nodes below the bifurcation

of the common iliac arteries. They include the following groups: pelvic NOS, hypogastric, obturator, iliac

(internal, external, NOS), sacral (lateral, presacral, promontory [Gerota’s] or NOS)

62



Data Element: Biopsy Result

Definition: Identify the result of each biopsy as specified on the biopsy report or in the clinic notes.

Rationale: Collection of information related to the result of performed biopsies allows for an assessment of

consequences associated with post-treatment surveillance PSA and imaging testing.

Suggested High Yield Locations in Medical Record for Information:






Allowable Values:

1. Benign

2. Malignant

3. Indeterminate

4. Unknown


Select “1” if the biopsy determined a benign finding or no malignancy.

Select “2” if the biopsy shows cancer (prostate cancer or other cancer) or indicates “consistent” with

cancer

Select “3” if biopsy findings were indeterminate or non-diagnostic (including “suspicious” but non-

diagnostic).

Select “4” if the results from the biopsy procedure are not known or are not included in the medical

record.

63


Web Form Section: Recurrence


A recurrence is defined as a tumor that is found during the surveillance period (starting at the end of primary

treatment).

If the medical records state there was a biochemical recurrence, this recurrence should be entered in the web

form

Please enter the following information:

Did the Patient have a Recurrence

Date of First Recurrence Detection (by any method)

Date of First Detection of Local Recurrence

Date of First Detection of Regional Recurrence

Did the Patient Develop Distant Metastatic Disease

Date of First Detection of Distant Recurrence

Distant Recurrence Type

Did the Patient have Surgery to Treat Recurrence

Date of Surgery

Anatomic Location of Surgery

Did the Patient have Radiation to Treat Recurrence

Date of Radiation Start

Date of Radiation End

Anatomic Location of Radiation

Did the Patient have Hormone Therapy to Treat Recurrence

Date of Hormone Therapy Start

Did the Patient have Chemotherapy to Treat Recurrence

Date of Chemotherapy Start

Did the Patient have other types of Treatment for Recurrence

Total Dose of Radiation

Medical records should continue to be reviewed for recurrence for a period of 8 years starting from the time

of the surveillance start date or until a documented distant recurrence, or death (whichever is first).

Dates can be entered in YYYMMDD format.

Recorded treatments are those performed for curative or non-curative/palliative intent

Once a distant recurrence is detected, continue to enter treatment for the recurrence for a period of 180 days

starting from the date of first detection of distant recurrence.

In the current special study, it is critical to be able to differentiate between a patient without a

documented recurrence in the medical record as opposed to a patient with unknown cancer status (no

reliable recurrence information available).

64


If the work up to a recurrence diagnosis is done during the surveillance window but the recurrence is not

found until after the window has ended, please enter the recurrence information.

If after reviewing these instructions the coding of recurrence is not clear, please click on the “Contact” link to

obtain feedback from study investigators and the study staff members.

65



Data Element: Did the Patient have a Recurrence?

Definition: Record if the patient had prostate cancer recurrence or not; often though not always, this will be by

elevated PSA. For patients who received primary radical prostatectomy, the date of recurrence may occur

immediately after the radical prostatectomy (e.g. patients with elevated PSA after radical prostatectomy).

Rationale: This study requires information on when recurrence is detected after primary treatment.


Urologist, radiation oncologist (if patients received radiation treatment), and primary care provider

(PCP/APP) are the most likely physicians/providers to monitor a patient after primary treatment.

Allowable Values:

1. Yes

2. No

3. Unknown


If No or Unknown, the following fields on the Recurrence tab will disable on this page. Please click Save

and continue.

o Date of First Recurrence Detection (by Any Method)

o Date of First Detection of Local Recurrence

o Date of First Detection of Regional Recurrence

o Did the Patient Develop Metastatic Disease

o Date of First Detection of Distant Recurrence

o Distant Recurrence Type

o Did the Patient have Surgery to Treat Recurrence

o Date of Surgery

o Anatomic Location of Surgery

o Did the Patient have Radiation to Treat Recurrence

o Date of Radiation Start

o Date of Radiation End

o Anatomic Location of Radiation

o Did the Patient have Hormone Therapy to Treat Recurrence

o Date of Hormone Therapy Start

o Did the Patient have Chemotherapy to Treat Recurrence

o Date of Chemotherapy Start

o Did the Patient have Other Types of Treatment for Recurrence

o Total Dose of Radiation

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Data Element: Date of First Recurrence Detection: either by PSA, Scans, Biopsy, or any

Other Method

Definition: Record date of the first detection of prostate cancer recurrence; often though not always, this will be

by elevated PSA. For patients who received primary radical prostatectomy, the date of recurrence may occur

immediately after the radical prostatectomy (e.g. patients with elevated PSA after radical prostatectomy).



Urologist, radiation oncologist (if patients received radiation treatment), and primary care provider

(PCP/APP) are the most likely physicians/providers to monitor a patient after primary treatment.

Allowable Values:

YYYYMMDD

00000000 (No recurrence)

99999999 (Patient was diagnosed with a recurrence but the date of the recurrence is completely unknown)

77777777 (Unknown if patient had a recurrence)


Recording Dates

Record as YYYYMMDD where MM is two-digit month, DD is two-digit day, and YYYY is



If only year of the local/regional recurrence is known enter as YYYY9999 (example 2007:

20079999).

Enter “99999999” if it is known that a patient had a recurrence but the date of the recurrence is completely

unknown.

Enter “77777777” if it is unknown whether the selected patient had a recurrence.

Enter 00000000 if the patient did not have a recurrence.

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Data Element: Date of First Detection of Local Recurrence

Definition: Record date of the first local recurrence diagnosis found in a patient’s medical record during the

surveillance period.

Local recurrence is defined as recurrence in the prostate or prostate bed.

This is defined by biopsy of the prostate or prostate bed, and pathology from this biopsy showing

recurrent prostate cancer. Date of local recurrence = date of this biopsy.

Alternatively, if biopsy is not done or information not available, local recurrence in the prostate or

prostate bed can be defined using imaging (date of local recurrence = date of imaging scan)







Allowable Values:

YYYYMMDD

00000000 (No local recurrence)

99999999 (Patient was diagnosed with a local recurrence but the date of the recurrence is completely unknown)

77777777 (Unknown if patient had a local recurrence)


Recording Dates




If only year of the local recurrence is known enter as YYYY9999 (example 2007: 20079999).

Enter “99999999” if it is known that a patient had a local recurrence but the date of the local recurrence is

completely unknown.

Enter “77777777” if it is unknown whether the selected patient had a local recurrence.

Enter 00000000 the patient did not have a local recurrence.

Use the following for determining dates of recurrence: 1. Pathology date: Record the date that the recurrence was pathologically confirmed. If there

is no pathology report in the medical record but there is documentation in the medical record

of a procedure yielding pathological confirmation of cancer, the procedure date or the date

of the record in the chart should be entered.

2. If information on #1 is not available, local recurrence in the prostate or prostate bed can be

defined using imaging (date of local recurrence = date of imaging scan)

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Data Element: Date of First Detection of Regional Recurrence

Definition: Record date of the first detection of regional recurrence found in a patient’s medical record during the

surveillance period. Regional nodes are nodes of the true pelvis, which essentially are the pelvic nodes below the

bifurcation of the common iliac arteries. They include the following groups: pelvic NOS, hypogastric, obturator,

iliac (internal, external, NOS), sacral (lateral, presacral, promontory [Gerota’s] or NOS)






Allowable Values:

YYYYMMDD

00000000 (No regional recurrence)

99999999 (Patient was diagnosed with a regional recurrence but the date of the recurrence is completely

unknown)

77777777 (Unknown if patient had a regional recurrence)


Recording Dates




If only year of the regional recurrence is known enter as YYYY9999 (example 2007: 20079999).

Enter “99999999” if it is known that a patient had a regional recurrence but the date of the regional recurrence

is completely unknown.

Enter “77777777” if it is unknown whether the selected patient had a regional recurrence.

Enter 00000000 if the patient did not have a regional recurrence.

This is usually detected by imaging (e.g. CT, MRI, PET scan). Biopsy of nodes seen on imaging is optional.

Date of regional recurrence = date of imaging that showed regional recurrence.

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Data Element: Did the Patient Develop Distant Metastatic Disease?

Definition: Record whether a patient had distant recurrence/metastasis during the surveillance period. Distant

recurrence/metastasis is recurrence that is not local and not regional.







Allowable Values:

1. Yes

2. No

3. Unknown


Distant recurrence/metastasis is recurrence that is not local and not regional.

Distant metastatic disease is usually detected by imaging (e.g. CT, MRI, PET scan, bone scan), visible

recurrence that is not a regional node. Examples of distant recurrence include:

Bone (including bone marrow) – this is the most common metastasis for prostate cancer

Brain (including choroid, CNS, pituitary gland, leptomeningeal, and frontal sinus)

Liver

Lung (including lymphangitic carcinomatosis) (does not include pleura or pleural effusion)

Distant nodal (nodes beyond the regional nodes as defined by AJCC)

a. Regional nodes are defined as: Regional nodes are nodes of the true pelvis, which essentially

are the pelvic nodes below the bifurcation of the common iliac arteries. They include the

following groups: pelvic NOS, hypogastric, obturator, iliac (internal, external, NOS), sacral

(lateral, presacral, promontory [Gerota’s] or NOS).

Other (including other organs not elsewhere classified)

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Data Element: Date of First Detection of Distant Recurrence/Metastasis

Definition: Specifies the date of the *FIRST* documented distant recurrence/metastasis during the surveillance

period. Distant recurrence/metastasis is recurrence that is not local and not regional.







Allowable Values:

YYYYMMDD

00000000 (No distant recurrence)

99999999 (Patient was diagnosed with a distant recurrence but the date of the recurrence is completely unknown)

77777777 (Unknown if patient had a distant recurrence)


Record the first detection of a distant recurrence/metastasis. This is usually the date of the first imaging scan

which showed any site of distant metastasis. Sometimes the imaging is followed by a biopsy, but the date of

biopsy is not important (date of biopsy is to be used only if the date of imaging is unknown).

Recording Dates




If only year of the distant recurrence is known enter as YYYY9999 (example 2007: 20079999).

Enter “99999999” if it is known that a patient had a distant recurrence but the date of the distant recurrence is

completely unknown.

Enter “77777777” if it is unknown whether the selected patient had a distant recurrence.

Enter 00000000 if the patient did not have a distant recurrence.

Only record the sites of distant metastasis at first detection of distant metastasis and within 180 days after this

time.


recurrence that is not a local or regional recurrence. Examples of distant recurrence include:

Bone (including bone marrow) – this is the most common metastasis for prostate cancer


Liver


Distant nodal (nodes beyond the regional nodes as defined by AJCC).

Regional nodes are defined as: Regional nodes are nodes of the true pelvis, which essentially are

the pelvic nodes below the bifurcation of the common iliac arteries. They include the following

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groups: pelvic NOS, hypogastric, obturator, iliac (internal, external, NOS), sacral (lateral,

presacral, promontory [Gerota’s] or NOS).

Other (including other organs not elsewhere classified)

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Data Element: Distant Recurrence Type

Definition: Type of distant recurrence (select all that apply).

Rationale: This study requires information on whether recurrence is detected after primary treatment.






Allowable Values:

1. No distant recurrence

2. Brain (including choroid, CNS, pituitary gland, leptomeningeal, and frontal sinus)

3. Liver

4. Lung (including lymphangitic carcinomatosis) (does not include pleura or pleural effusion)

5. Bone (including bone marrow)

6. Distant nodal (nodes beyond the regional nodes as defined by AJCC)

7. Other (including other organs not elsewhere classified)

8. Unknown (patient known to have distant metastases but site or sites unknown)


Please select all that apply (a patient can have multiple areas of distant metastasis simultaneously)

Only record the sites of distant metastasis at first detection of distant metastasis and within 180 days after

this time.


recurrence that is not a local or regional recurrence. Examples of distant recurrence include:


Liver


Bone (including bone marrow)

Distant nodal (nodes beyond the regional nodes as defined by AJCC)

Regional nodes are defined as: Regional nodes are nodes of the true pelvis, which

essentially are the pelvic nodes below the bifurcation of the common iliac arteries. They

include the following groups: pelvic NOS, hypogastric, obturator, iliac (internal, external,

NOS), sacral (lateral, presacral, promontory [Gerota’s] or NOS).

Other (including other organs not elsewhere classified such as adrenal gland, kidney, skin)

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Data Element: Did the Patient have Surgery to Treat Recurrence?

Definition: Surgery could be used to treat any of the defined local, regional, or distant sites of recurrence as

defined in previous pages.

Rationale: This measure allows for an assessment of whether the detected recurrence resulted in a diagnosis that

was treated. Only surgery performed/administered within 180 days of the documented local/regional/distant

recurrence should be recorded.


Operative reports (at your institution or correspondence from other institutions)

Hospital discharge summaries (at your institution or correspondence from other institutions)


radiation oncologist; urologist; other surgeon; other provider

Allowable Values:

1. Yes

2. No

3. Unknown


This answer to this question should be “yes” if the patient had surgery performed for his local, regional,

or distant recurrence.

Only record the sites of first surgery for recurrence.

Only surgery performed/administered within 180 days of the documented local/regional/distant


Do not include simple biopsy as surgery.

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Data Element: Date of First Surgery for Recurrence











Allowable Values:

YYYYMMDD

00000000 (No surgery was performed for recurrence or no recurrence)

99999999 (Surgery was performed for recurrence but the date of the surgery is completely unknown)

77777777 (Unknown if patient had surgery for a recurrence)


Record the first surgery performed for a recurrence. Do not include simple biopsy as surgery.

Recording Dates




If only year of the surgery is known enter as YYYY9999 (example 2007: 20079999).

Enter “99999999” if it is known that a patient had surgery for recurrence but the date of the surgery is

completely unknown.

Enter “77777777” if it is unknown whether the selected patient had surgery for a recurrence.

Enter 00000000 if no surgery was performed for recurrence.

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Data Element: Anatomic Location of First Surgery for Recurrence











Allowable Values:

1. No surgery was done for recurrence

2. Prostate with or without nodal dissection

3. Nodal dissection only

4. Bone

5. Lung

6. Liver

7. Other


Only record the sites of first surgery for recurrence.

Only surgery performed/administered within 180 days of the documented local/regional/distant


Do not include simple biopsy as surgery.

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Data Element: Did the Patient have Radiation to Treat Recurrence?

Definition: Radiation (external beam radiation and/or brachytherapy) could be used to treat any of the defined

local, regional, or distant sites of recurrence as defined in previous pages.


was treated. Radiation treatment can occur at any time after detection of recurrence.


Radiation treatment summary note.


radiation oncologist; urologist; other provider

Allowable Values:

1. Yes

2. No

3. Unknown


Record the first radiation performed for a recurrence.

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Data Element: Date of Radiation Start

Data Element: Date of Radiation End









Allowable Values (date of radiation start and end):

YYYYMMDD

00000000 (No radiation was performed for recurrence or no recurrence)

99999999 (Radiation was performed for recurrence but the date of the radiation is completely unknown)

77777777 (Unknown if patient had radiation for a recurrence)


This information is most easily found on the radiation treatment summary note


Recording Dates




If only year of the radiation is known enter as YYYY9999 (example 2007: 20079999).

Enter “99999999” if it is known that a patient had radiation for recurrence but the date of the radiation is

completely unknown.

Enter “77777777” if it is unknown whether the selected patient had radiation for a recurrence.

Enter 00000000 if no radiation was performed for recurrence.

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Data Element: Anatomic Location of First Radiation for Recurrence






Radiation treatment summary note



Allowable Values:

1. Prostate bed (for patients who had prior prostatectomy)

2. Prostate (if patient still has a prostate)

3. Abdominal/pelvic lymph nodes

4. Bone

5. Lung

6. Liver

7. Other

8. No radiation was done to treat recurrence or unknown if radiation was used


This information is most easily found on the radiation treatment summary note. Record the first radiation performed for a recurrence.

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Data Element: Did the Patient have Hormone Therapy to Treat Recurrence?

Data Element: Date of Hormone Therapy Start

Definition: Hormone therapy (aka “androgen deprivation therapy”) could be used to treat any of the defined

local, regional, or distant sites of recurrence as defined in previous pages. Hormone therapy here is defined in an

identical way as hormone therapy for initial treatment (which is a standard data element for NCDB).


was treated. Hormone therapy can occur at any time after detection of recurrence.




Allowable Values (did the patient have hormone therapy to treat recurrence?):

1. Yes

2. No

3. Unknown

Allowable Values (date of hormone therapy start for recurrence):

YYYYMMDD

00000000 (No hormone therapy was performed for recurrence)

99999999 (Hormone therapy was performed for recurrence but the date of the hormone therapy is unknown)

77777777 (Unknown if patient had hormone therapy for a recurrence)


Record the date of first hormone therapy given after first detection of recurrence

Recording Dates




If only year of the hormone therapy is known enter as YYYY9999 (example 2007: 20079999).

Enter “99999999” if it is known that a patient had hormone therapy for recurrence but the date of the hormone

therapy is completely unknown.

Enter “77777777” if it is unknown whether the selected patient had hormone therapy for a recurrence.

Enter 00000000 if no hormone therapy was performed for recurrence.

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Data Element: Did the Patient have Chemotherapy to Treat Recurrence?

Data Element: Date of Chemotherapy Start

Definition: Chemotherapy could be used to treat any of the defined local, regional, or distant sites of recurrence

as defined in previous pages.


was treated. Chemotherapy can occur at any time after detection of recurrence.




Allowable Values (did the patient have chemotherapy to treat recurrence?):

1. Yes

2. No

3. Unknown

Allowable Values (date of chemotherapy start):

YYYYMMDD

00000000 (No chemotherapy was performed for recurrence)

99999999 (Chemotherapy was performed for recurrence but the date of the chemotherapy is completely

unknown)

77777777 (Unknown if patient had chemotherapy for a recurrence)


Record the date of first chemotherapy given after first detection of recurrence

Recording Dates




If only year of the chemotherapy is known enter as YYYY9999 (example 2007: 20079999).

Enter “99999999” if it is known that a patient had chemotherapy for recurrence but the date of the

chemotherapy is completely unknown.

Enter “77777777” if it is unknown whether the selected patient had chemotherapy for a recurrence.

Enter 00000000 if no chemotherapy was performed for recurrence.

Additional Instructions for Data Collection:

Consistent with FORDS guidelines for collecting chemotherapy administration from patient medical

records, please refer to the SEER*Rx Interactive Drug Database (http://seer.cancer.gov/) for a list of

chemotherapeutic agents.

http://seer.cancer.gov/

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Data Element: Did the Patient have Other Types of Treatment for Recurrence?

Definition: “Other” treatment is not surgery, not any type of radiation, not any type of hormone therapy, and not

any type of chemotherapy.

Examples could include (not exhaustive): ablation, cryotherapy, HIFU (high intensity focused ultrasound)

Other treatment could be used to treat any of the defined local, regional, or distant sites of recurrence as



was treated. Other treatment can occur at any time after detection of recurrence.



radiation oncologist; radiologist; urologist; other provider

Allowable Values (did the patient have other types of treatment for recurrence?):

1. Yes

2. No

3. Unknown

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Data Element: Total Dose of Radiation









Allowable Values:

1 to 200 Gy

00000000 (No radiation was performed for recurrence)

77777777 (Unknown if radiation was performed for recurrence)

99999999 (Radiation was performed for recurrence but the dose of the radiation is unknown)


This information is most easily found on the radiation treatment summary note.

Please note the unit of radiation dose. Gy = 100 cGy. Record all doses in Gy for this study.


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Web Form Section: New Cancer Diagnosis

Data Element: Did the Patient Develop a New Cancer (Not Related to Prostate Cancer)?

Data Element: Date of New Primary Diagnosis

Definition: Record the date of the first pathologically-confirmed or clinically-confirmed new primary diagnosis

found in a patient’s medical record during the surveillance period.

New primary caner is a different type of cancer (not prostate cancer).

Do not count prostate cancer local, regional, or distant metastasis.

Rationale: This data item is an important endpoint of the study and is used to assess the role of surveillance on

the detection of new primary cancers.



radiation oncologist; urologist, surgical oncologist; other provider)


Biopsy/Pathology Reports (at your institution or correspondence from other institutions)


Allowable Values (did the patient develop a new cancer?):

1. Yes

2. No

3. Unknown

Allowable Values (date of new primary diagnosis):

YYYYMMDD

99999999 (Patient was diagnosed with a new primary cancer but the date of the new primary is completely

unknown)


Reminder: Non-melanoma skin cancers should not be included as new primary cancers

Recording Dates



o If only month and year is known, enter as YYYYMM99 (example: June, 2007 = 20070699).

o If only year of the new primary cancer diagnosis is known, enter as YYYY9999 (example 2007:

20079999).

Enter “99999999” if it is known that a patient had a new primary cancer but the date of the new primary

cancer diagnosis is completely unknown.

Use the following hierarchy for determining dates of new primary:

1. Pathology date: If there is no path report in the medical record but there is documentation in the

medical record of a procedure yielding pathological confirmation of lung cancer (for example), the

procedure date or the date of the record in the chart should be entered.

2. Date of imaging study used to confirm suspected new primary cancer.

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3. Date of clinical diagnosis: Statement in doctor’s note of new primary cancer.

Note: It could be difficult to differentiate between a new primary cancer and a recurrence/metastasis of

prostate cancer. Registrars should look in the medical record for a note from the physician to see how the

cancer was classified.

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Web Form Section: New Cancer Diagnosis

Data Element: New Cancer Type

Definition: Site of first diagnosis of a new cancer other than prostate, not including metastatic prostate cancer or

non-melanoma skin cancer.

Rationale: This data item is an important endpoint of the study and is used to assess the role of surveillance on

the detection of new primary cancers.



radiation oncologist; urologist, surgical oncologist; other provider)


Biopsy/Pathology Reports (at your institution or correspondence from other institutions)


Allowable Values:

Code using ICD-O-3 Topography Codes in a manner consistent with the Ford’s Manual (see “Primary Site,”

NAACCR Item #400).


Reminder: Non-melanoma skin cancers should not be included as new primary cancers

When the date of the first new non-prostate primary cancer diagnosis is entered, a drop-down box will

open up. Enter the ICD-O-3 code corresponding to the site of the new primary cancer. ICD-O-3

Topography codes are indicated by a “C” preceding the three-digit code number. Do not record the

decimal point.

It is important that the site of a metastatic prostate cancer not be included here.

Consult the physician advisor to identify the primary site or the most definitive site code if the medical

record does not contain that information.

Follow the Instructions for Coding in ICD-O-3, pages 20-40 and in the current SEER Multiple Primary

and Histology Coding Rules to assign site for solid tumors.

Follow the instructions in Hematopoietic and Lymphoid Neoplasm Case Reportability and Coding

Manual and the Hematopoietic and Lymphoid Neoplasms Database (Hematopoietic DB) for assigning

site for lymphomas, leukemia and other hematopoietic neoplasms.

PCORI Prostate Special Study Instructions

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Transcript of PCORI Prostate Special Study Instructions