RTOG 534 A Phase III Trial Of Short Term Androgen Deprivation With Pelvic Lymph Node Or Prostate Bed Only Radiotherapy (SPPORT) In Prostate Cancer Patients With A Rising PSA After Radical Prostatectomy
Subjects for this study will be enrolled by the Moncrief Radiation oncology Department at the Simmons Cancer Center. intensity Modulated RT (iMRT) is allowed for this study.
arm 1: Prostate bed radiotherapy alone: PBRT 64.8-70.2 Gy (1.8 Gy per fraction). Radiotherapy will
start within 42 days (+/-14 days) after registration.
arm 2: Prostate bed radiotherapy 60 days (+/-14 days) after starting neoadjuvant and concurrent short-term androgen deprivation: PBRT 64.8-70.2 Gy (1.8 Gy per fraction) + neoadjuvant and concurrent short-term androgen deprivation for 120-180 days
arm 3, Pelvic lymph node + prostate bed radiotherapy 60 days (+/-14 days) after starting neoadjuvant and concurrent short-term androgen deprivation: PLnRT to 45 Gy (1.8 Gy per fraction) and PBRT to 64.8-70.2 Gy
(1.8 Gy per fraction) + neoadjuvant and concurrent short-term androgen deprivation for 120-180 days,
Short term androgen deprivation will begin from the start of luteinizing hormone releasing hormone agonist injection within 6 weeks after registration, and will consist of total androgen deprivation, using a combination of antiandrogen and luteinizing hormone releasing hormone agonist therapy for a total of 4-6 months. The antiandrogen will be either flutamide at 250 mg p.o. TiD or bicalutamide at 50 mg p.o. QD. antiandrogen therapy should begin at approximately the same time as LHRH agonist injection but may be started up to two weeks earlier. LHRH agonist injection will consist of analogs approved by the FDa (or by Health Canada for Canadian institutions), e.g., leuprolide, goserelin, buserelin, or triptorelin and may be given in any possible combination.
The RToG Required Sample Size is 1764. a total of 22 patients will be required to complete the study locally. The maximum number of patients to be consented is 18, allowing for screen failures and early withdrawls. The expected time to completion of enrollment is 24 months.
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