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Prostate CancerInnovations 2015

Peter D. Sershon, M.D.Metropolitan Urologic Specialists, P.A.

Chief of Surgery, United HospitalMedical Director, Robotic Surgery Program, United Hospital

MISSION

To Give Hope and

Alleviate Suffering

“Nice To meet You Doctor”

“Please Don’t Miss Something Bad” Mission

To Prevent Suffering and

Dying From Prostate Cancer

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Prostate CancerWhich Is True?

1. A slow growing cancer which is not life threatening

2. The second leading cause of cancer death in men

3. Never needs treatment

4. If not caught early is not curable

5. All of the above

EpidemiologyU.S. - Most common non-skin malignancy in men

Prostate Breast217,730 cases/yr 207,090 cases/yr

28% of new cancer cases 28% of new cancer cases

32,050 deaths 39,840 deaths

1/6 chance of dvlp. 1/8 chance of dvlp.

Hormone dependent Hormone dependent

American Cancer Society. Cancer Facts and Figures 2010

American Cancer Society 2011

240,890 New Cases

33,720 Deaths

RISKS:

AGE- 97% occurs in men 50 and older

FAMILY HISTORY

RACE/ETHNICITY

African-American men have one of the highest prostate cancer incidence rates in the world, and a death rate more than twice that of white males.

Epidemiology

30% of Men in Their 30s have Microfoci of Prostate Cancer

80% of Men in Their 80s have Prostate Cancer

Is This Prostate Cancer CLINICALLY SIGNIFICANT

Prostate Cancer DetectionNo Spread – No SymptomsYou Must Screen.

Annual Exam :-Prostate Specific Antigen (PSA)-Digital Rectal Exam (DRE)

PSAAdvantagesDetection of non-palpable cancerEarly sign of progressive disease

Disadvantage

Confusing

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PSA

Specific to the Prostate (Almost)

Not a Cancer Marker

Change Indicates “Trauma” to the Prostate

Same Age Same PSA

THE PSA ERAHow Has it Gone?

75 Percent Reduction in Presentation with Metastatic Prostate Cancer.

42 Percent Reduction in Age-Adjusted Prostate Cancer Mortality Over the Most Recent 20 Years.

SEER DATA

Prostate Cancer DetectionCons

1. Have to Screen Too Many Men-Weak Risk: Just an Annual PSA and DRE

2. Have to Biopsy Too Many Men-Moderate Risk: Infection,Pain,Anxiety-Room for Improvement

3. Have to Treat Too Many Men-High Risk: Permanent Negative Change-Room for Improvement

PROSTATE CANCERFacts

Not all men need to be screened for prostate cancer.

Not all abnormal PSA tests need a biopsy

Not all prostate cancers need treatment

BUT: If CLINICALLY SIGNIFICANT Prostate Cancer is not detected early it is INCURABLE

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Clinically Significant Prostate CancerThe Goal is to Diagnose and Treat Clinically Significant

Cancer:

“A Cancer that if Left Undetected will Decrease Survival and/or Significantly Decrease Quality of

Life”

This Decision Has to be Customized at an Individual Level

Prostate Cancer Treatment

Cancer Stage is the Most Important Criteria

If Metastatic - No Chance for Cure

Only Effective Option is Castration

Surgical or Medical Suppression of Testosterone

Cancer Will Become Resistant

Mission

To Prevent Suffering and

Dying From Prostate CancerWhile Reducing Risk From Diagnosis and Treatment

Prostate Cancer- Diagnosis

Must have tissue diagnosis

Prostate biopsyUltrasound guided or DigitalComplicationsBleedingInfectionDiscomfort

Prostate Cancer-Diagnosis

Tissue Diagnosis- why?

Volume of cancer- number of cores positiveGrade of cancer

Prostate Cancer- TreatmentMust CUSTOMIZE therapy to

patient

Criteria:Age HealthLife expectancyCancerStage and Grade

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Prostate Cancer-Treatment

Cancer StageMost important criteria If metastatic—no chance for cureOnly effective option is castrationSurgical or medical suppression of

testosteroneCancer will become resistant

Prostate Cancer- Treatment

Radical Prostatectomy

Radiation Therapy

Hormonal Therapy

Cryotherapy

Chemotherapy

HIFU

Observation

PC - Treatment

Robotic Assisted Lap Radical Prostatectomy

A computer enhanced surgical system

Surgeon operates at the console

Assistant surgeon is next to the patient

What is the da Vinci® Surgical System?

Urologic Robotic Procedures

Radical prostatectomy

Pyeloplasty

Psoas hitch, Boari flap

Ureteral reimplantation

Cystectomy, neobladder

Renal transplantation

Adrenalectomy

Nephrectomy

Goal of Prostate Cancer Treatment

The Trifecta or Home Run

Cancer (PSA) Control: patient does not die from prostate cancer

Continent with normal urinary function

Potent with preservation of erectile function

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Prostate CancerRisk Reduction

Two New Improvements:

1. Biomarkers

2. Prostate MRI

Prostate Cancer Biomarkers

Blood

Urine

Tissue

Prostate Cancer BiomarkersWhether to Biopsy

PSA- blood

PHI- blood

PCA3- urine

Whether to Re-Biopsy

PCA3- urine

ConfirmDX- tissue

Whether to Treat

OncotypeDx- tissue

Prolaris- tissue

Prostate Cancer-Treatment

Active Surveillance- ”watchful waiting” This is a treatment decisionAt least 50% will require therapyDo not observe healthy men with a good

life expectancy and a clinically significant tumor

Cannot predict time of metastasis

Surveillance is Under-utilized

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Adapted from Cooperberg MR, et al. BJU Int;2013

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mb

er o

f p

atie

nts

(%

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CAPRA score

100

80

60

40

20

00 2 3 4 5 6 7 8 9 101

AS/WW RP Brachy EBRT Cryo ADT

8.52.0 6.5 5.8 4.4 2.9 2.6 3.3

24.733.6

44.549.951.7

56.759.7

90.0

16.117.8

7.0

11.1

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13.714.0

1.0

5.22.86.0

8.1

3.68.9

12.8

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11.5

12.3

5.7

14.0

16.0

5.2

21.1

20.2

5.6

27.0

2.6 2.59.0

4.1

15.5

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20.0

5.0

12.6

6.0

19.2

5.3

72.267.3

54.3

7.4

20.9

5.7

38.0

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NCCN Guidelines : Active Surveillance for

Very Low and Low Risk Patients

37NCCN Clinical Practice Guidelines in Oncology™, Prostate Cancer v2.2013. © National Comprehensive Cancer Network, 2013NCCN is a registered trademark of the National Comprehensive Cancer Network which does not endorse any product or

Prostate Cancer “Low Risk Patients”

Men with low-risk features at biopsy who undergo surgery:

30-40% will have high grade, high stage disease or both

There is currently no way to select them out

Clear Need and Opportunity to Improve 

Prostate Cancer Management

Significant driver of over treatment is limited accuracy of low risk classification based on measures available today

Despite low (3%) risk of disease progression1 and modest treatment benefit2, >90%3 of low risk men receive immediate treatment

1. Boorjian SA, et al. Urol Oncol 2008; 2. Wilt TJ, et al. N Engl J Med. 2012; 3. Cooperberg MR et al. J Clin Oncol 2010; 4. Otis W. Brawley, MD, American Cancer Society

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“We desperately need the ability to predict which patient has a localized cancer that is going to metastasize and cause suffering and death, and which patient has a cancer that is destined to stay 

in the patient's prostate for the remainder of his life.”‐American Cancer Society4

The Oncotype DX® Prostate Cancer Assay

WHAT is the test? A tumor gene expression assay which produces a

Genomic Prostate Score (GPS) to help guide initial treatment decisions at the time of biopsy

WHO is the test for? Newly diagnosed men with low to

low-intermediate risk prostate cancer (GS 3+3, low volume 3+4)

WHY do the test? To improve risk stratification by incorporating

individual underlying tumor biology To identify appropriate patients for Active

Surveillance (AS) or immediate treatment

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Overwhelming and growing evidence of diagnostic accuracy for multi-parametric prostate MRI1

Positive predictive values (PPVs) above 90% in recent articles1

Correlation of MRI performed with whole-mount histopathologic specimens

Volume of published literature, increasing clinical evidence and “buzz” echoes breast MRI of 10 years ago

Prostate ImagingMagnetic Resonance Imaging (MRI)

1 Chen M. et al. Prostate cancer detection: comparison of T2-weighted imaging, diffusion-weighted imaging, proton magnetic resonance spectroscopic imaging, and the three techniques combined. Acta Radiol. 2008 Jun;49(5):602-10

Prostate MRIDynaCAD V3.0

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UroNav Fusion Biopsy System

Integrated mobile workspot

Full DynaCAD integration of MR data

DICOM compliant device

EM tracking system

Imaging system interface

QA phantom & accessories

Exporting diagnostic 3D information from a prior MRI exam; prostate gland & MR-suspicious lesions

Registering the diagnostic MR exam data with real-time TRUS

Using TRUS to guide the biopsy needle to the visible suspicious MR lesions

MRI / Ultrasound Fusion

What is it, exactly?

Prostate MRI May allow visualization of high volume and possible

high grade disease in potential observation candidate

May be useful for directed prostate biopsies

May allow FOCAL THERAPY

Goal of Prostate Cancer Treatment

The Trifecta or Home Run

Cancer (PSA) Control: patient does not die from prostate cancer

Continent with normal urinary function

Potent with preservation of erectile function

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High Intensity Focused Ultrasoundwith the Sonablate® 500 Sonablate® 500 System

10 - 12mm

3ON/3ON/3OFF

Prostate Focal Therapy

Will require precise energy source

For the select patient: Prostate cancer Management, not Cure

This is a new discussion

Summary Predictive models and technologies are improving to

allow more accurate prediction of who requires treatment of prostate cancer

Diagnostic capabilities are improving with these same technologies

Prostate cancer treatment is at the doorstep of low risk, effective therapies

All of this is only useful if men are screened for prostate cancer so……….

Prostate CancerPlease Be Screened