Radiation Oncology/RTOG Trials/9902


  • Title: A Phase III Protocol of Androgen Suppression (AS) and Radiation Therapy (RT) vs. AS and RT Followed by Chemotherapy With Paclitaxel, Estramustine, and Etoposide (TEE) for Localized, High-Risk Prostate Cancer
  • Objective: To assess the relative efficacy of the combination of androgen suppression + RT followed by androgen suppression vs. AS + RT followed by TEE chemotherapy + androgen suppression in a population of patients with clinically-localized prostate cancer with unfavorable prognostic factors. The primary endpoint will be survival, but biochemical control (freedom from PSA failure), local control, disease free survival, and freedom from distant metastasis will also be assessed.
  • Protocol:
    • Arm 1: AS x 8 weeks followed by 70.2 Gy RT + concurrent AS x 16 weeks
    • Arm 2: AS x 8 weeks followed by 70.2 Gy RT + concurrent AS x 16 weeks + TEE x 4 cycles (start 28 days after completion of RT)
  • Eligibility:
    • (any cT and GS >=7 and PSA 20-100) or
    • (>=cT2 and GS >=8 and PSA <100)
    • N0M0
  • Enroll Target: 1440
  • Activation: January 11, 2000
  • Closed: October 4, 2004
    • This closure is for patient safety due to the observance of increased thromboembolic toxicity due to Emcyt.