Protocols for Advanced Prostate Cancer and/or Local Failure After Radical Prostatectomy
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Transcript of Protocols for Advanced Prostate Cancer and/or Local Failure After Radical Prostatectomy
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Protocols for Advanced Prostate Cancer and/or Local Failure After
Radical Prostatectomy
Isaac Powell, MD
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ARS
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Case Presentation
• Local spread outside of the prostate gland with or without positive surgical margins after radical prostatectomy
• Detectable PSA or rising PSA after surgery
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Post-op advanced stage
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Prostate Cancer-Specific Survival
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D'Amico A, et al. Prostate cancer mortality based on PSADT after
surgery. JNCI 2003
Prostate cancer specific mortality
<2 mo.
<3
<4
<6
<12
PSADT
Per
cent
Dea
d of
Pro
stat
e C
ance
r
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A RANDOMIZED, OPEN LABEL, MULTICENTER, PHASE III, 2-ARM STUDY OF
ANDROGEN DEPRIVATION WITH LEUPROLIDE, +/- DOCETAXEL FOR
CLINICALLY ASYMPTOMATIC PROSTATE CANCER SUBJECTS WITH A RISING PSA
FOLLOWING DEFINITIVE LOCAL THERAPY
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Schematic of Trial Design
• Rising PSA following radical prostatectomy
• PSA doubling time of <9 months
• Minimum PSA of 1• Testosterone >100ng/ml
RA
ND
OM
IZE
•Docetaxel 75 mg/m2 q 3 weeks x 10 cycles
•GnRH agonist x 18 months
•Bicalutamide x 4 weeks
•GnRH agonist x 18 months•Bicalutamide x 4 weeks
Arm A
Arm B
The hypothesis of the study is that Progression Free Servival probability will increase from 50% to 65% a minimum 36 months following randomization.
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Additional Eligibility
• Subjects in this group may have no radiographic findings that are clinically suspicious for metastatic disease.
• Salvage Radiotherapy is allowable and encouraged where appropriate (for example, biochemical recurrence with a positive margin)
Version 3.0 / March 24, 2008 Amendment #2
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Primary Objective
• Progression Free Survival within the period of 18 months of therapy and at least 18 months follow-up.
• Progression Free Survival is determined as the time from randomization to:– the first documentation of detectable PSA or – radiographic progression or – to death
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Secondary Objectives
• To evaluate cancer specific survival
• To compare overall survival between the 2 treatment groups
• Molecular correlates with clinical outcomes– Tissue blocks– Serum/DNA
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Radiotherapy Protocol After Surgery (closed)
Adjuvant Radiotherapy for Pathological T3N0M0 Prostate Cancer Significantly Reduces Risk of Metastases and Improves Survival: Long-Term Followup of a Randomized Clinical Trial
Ian M. Thompson,*,† Catherine M. Tangen, Jorge Paradelo, M. Scott Lucia,Gary Miller,‡ Dean Troyer, Edward Messing, Jeffrey Forman, Joseph Chin,Gregory Swanson, Edith Canby-Hagino and E. David Crawford
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Materials and Methods: A total of 431 men with pT3N0M0 prostate cancer wererandomized to 60 to 64 Gy adjuvant radiotherapy or observation. The primarystudy end point was metastasis-free survival.
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Figure 1 Metastasis-free survival by treatment arm
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Conclusions: Adjuvant radiotherapy after radical prostatectomy for a man withpT3N0M0 prostate cancer significantly reduces the risk of metastasis and increasessurvival.
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Lymph node metastasis
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Conclusion
• Locally advanced prostate cancer plus early aggressive combination therapy equal long term survival and possibly “cure”.