Survey
* Your assessment is very important for improving the workof artificial intelligence, which forms the content of this project
* Your assessment is very important for improving the workof artificial intelligence, which forms the content of this project
Protocols for Advanced Prostate Cancer and/or Local Failure After Radical Prostatectomy Isaac Powell, MD ARS ? ? 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 Post-op advanced stage Prostate Cancer-Specific Survival Prostate cancer specific mortality PSADT Percent Dead of Prostate Cancer <2 mo. <3 <4 <6 <12 D'Amico A, et al. Prostate cancer mortality based on PSADT after 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 Schematic of Trial Design RANDOMIZE • Rising PSA following radical prostatectomy • PSA doubling time of <9 months • Minimum PSA of 1 • Testosterone >100ng/ml Arm A •Docetaxel 75 mg/m2 q 3 weeks x 10 cycles •GnRH agonist x 18 months •Bicalutamide x 4 weeks Arm B •GnRH agonist x 18 months •Bicalutamide x 4 weeks The hypothesis of the study is that Progression Free Servival probability will increase from 50% to 65% a minimum 36 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 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 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 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, Gary Miller,‡ Dean Troyer, Edward Messing, Jeffrey Forman Gregory Swanson, Edith Canby-Hagino and E. David Crawfo Materials and Methods: A total of 431 men with pT3N0M0 prostate cancer were randomized to 60 to 64 Gy adjuvant radiotherapy or observation. The primary study end point was metastasis-free survival. Figure 1 Metastasis-free survival by treatment arm Conclusions: Adjuvant radiotherapy after radical prostatectomy for a man with pT3N0M0 prostate cancer significantly reduces the risk of metastasis and increases survival. Lymph node metastasis Conclusion • Locally advanced prostate cancer plus early aggressive combination therapy equal long term survival and possibly “cure”.