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Protocols for Advanced Prostate Cancer and/or Local Failure After Radical Prostatectomy

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

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Protocols for Advanced Prostate Cancer and/or Local Failure After Radical Prostatectomy

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  1. Protocols for Advanced Prostate Cancer and/or Local Failure After Radical Prostatectomy Isaac Powell, MD

  2. ARS ? ??

  3. 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

  4. Post-op advanced stage

  5. Prostate Cancer-Specific Survival

  6. Prostate cancer specific mortality PSADT <2 mo. <3 Percent Dead of Prostate Cancer <4 <6 <12 D'Amico A, et al. Prostate cancer mortality based on PSADT after surgery. JNCI 2003

  7. 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

  8. Schematic of Trial Design Arm A RANDOMIZE • Rising PSA following radical prostatectomy • PSA doubling time of <9 months • Minimum PSA of 1 • Testosterone >100ng/ml • 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 months following randomization.

  9. 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

  10. 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

  11. 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

  12. 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

  13. 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.

  14. Figure 1 Metastasis-free survival by treatment arm

  15. Conclusions:Adjuvant radiotherapy after radical prostatectomy for a man with pT3N0M0 prostate cancer significantly reduces the risk of metastasis and increases survival.

  16. Lymph node metastasis

  17. Conclusion • Locally advanced prostate cancer plus early aggressive combination therapy equal long term survival and possibly “cure”.

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