Intergroup (NCIC, SWOG) Phase III Randomized Trial Comparing Intermittent Versus Continuous Androgen Suppression for Patients with Prostate-Specific-Antigen Progression in the Clinical Absence of Distant Metastases Following Radiotherapy for Prostate Cancer

Pt must have histologic or cytologic confirmed adenocarcinoma of the prostate prior to initiation of RT. Pt must have previous pelvic radiotherapy for PC (either post radical prostatectomy or as primary management). Pts tx'd w/brachytherapy w/curative intent are eligible provided that the date of the implant is > 30 mos prior to rand. W/in 28 days prior to randomization, pt must have serum PSA greater than 3 ng/ml & higher than the lowest level recorded previously since the end of RT. Pt must have serum testosterone greater than 5 nmol/L w/in 28 days prior to randomization. Pt must have no definite evidence of metastatic disease. Pts may have clinical evidence of local disease. Chest x-rays, bone scan w/in 56 days prior to randomization which are negative for mets. Pt must have no RT w/in the 12 mos preceding randomization. Hormonal tx rec'd w/and either prior to, during or immediately post radical radiotherapy or prostatectomy must have been rec'd for a maximum duration of 12 mos and completed at least 12 mos prior to randomization. Pt must have ECOG PS of 0 or 1. Pt must be able and willing to complete the QOL questionnaires in either English or French and have already completed the baseline assessment. Pt must have bilirubin, SGOT/SGPT, LDH and Creatinine of less than/equal 1.5 x IULN w/in 28 days prior to randomization. Pt must not have chronic liver disease.

CANCER CONTROL CREDIT: 0.5
TREATMENT CREDIT: 1.0