Adjuvant radiation, androgen deprivation, and docetaxel for high-risk prostate cancer post-prostatectomy: Results of RTOG 0621.

5031 Background: Phase III trials have shown benefit in progression-free survival and in some cases overall survival with adjuvant radiation therapy (ART) in men with adverse pathologic findings at radical prostatectomy (RP). Despite ART, a high-risk group of patients has been defined with 50% risk of progression at 3 years, a risk factor for prostate cancer specific mortality. RTOG 0621 is a single-arm phase II trial that assessed whether addition of androgen deprivation (ADT) and docetaxel to ART would increase freedom from progression (FFP) at 3 years from 50% to ≥ 70% in these high-risk patients. Methods: Eligible subjects had prostatic adenocarcinoma who underwent RP with PSA nadir > 0.2 and Gleason score ≥ 7 or PSA nadir ≤ 0.2 with Gleason score ≥ 8 and ≥ pT3. Subjects received 6 months of ADT + RT to the pelvis with prostatic fossa boost to 66.6 Gy followed in one month with 6 cycles of docetaxel 75 mg/m2 every 21 days. The primary objective was to assess whether addition of ADT and docetaxel to AR...