Radiation Oncology/RTOG Trials/0011

RTOG 00-11 (PROSTATE)

• Title: Phase III Randomized Study of Adjuvant Therapy for High Risk pT2-3N0 Prostate Cancer
• Objective: The revised study design will test if the addition of androgen suppression to radiation therapy in patients with unfavorable pathologic stage pT3N0M0 prostate cancer leads to better overall survival than radiation therapy alone.
• Protocol:
  • Arm 1: RP followed by AS x 2 years + 63.0 - 66.6 Gy RT
  • Arm 2: RP followed by 63.0 - 66.6 Gy RT
  • Arm 3: RP followed by AS x 2 years (CLOSED EARLY DUE TO NON-ACCRUAL)
• Eligibility:
  • Status post RP
  • (pT2 and GS 7-10 and preop PSA > 10 and +SM) or
  • (pT3 and GS 7-10 and (PSA > 10 or +SM or SVI) or (pT3 and GS <7 and 2 of above risk factors)
• Enrollment Target: 1398 patients
• Activation: July 13, 2001
• Terminated: May 7, 2004 DUE TO NON-ACCRUAL