Phase II Study of Combined External Beam Radiation Therapy (EBRT), Brachytherapy (PB), Total Androgen Suppression (TAS), and Adjuvant Docetaxel (AD) in Poor-Risk, Localized Prostate Cancer (Pca)

4764 Background: Encouraging responses rates to Docetaxel in advanced PCa have been shown. However, our understanding of Docetaxel with radiation in localized PCa is limited. This prospective, phase II study evaluates the efficacy and safety of AD when combined with EBRT, PB, and TAS in high-risk, localized PCa. Methods: Inclusion criteria: T3/T4, or Gleason score (GS) 7 and PSA >10 or GS 8–10 and PSA >7 without extrapelvic disease, no prior chemotherapy or EBRT, no prior androgen deprivation, KPS ≥ 70%, and adequate hepatic, renal, cardiac, and bone marrow reserve. Patients received pelvic EBRT (45.0Gy) followed by a permanent PB implant 4 weeks after EBRT. AD was started 1 month after PB at 35 mg/m2 weekly x 3 q 4wks x 3 mos. TAS (anti-androgen x 4 wks and LHRH x 2 yrs) started day 1 of EBRT. Results: 36 patients have been enrolled from 6/00–11/03. One pt discontinued after EBRT and another pt refused chemotherapy resulting in 34 evaluable for this report. Median age was 63 years (51–78), median baseline PSA 17.8 (1.2–84.6) and a GS of 8–10 in 50%. PSA relapse-free survival (PRFS) time was calculated from the date of EBRT initiation to the date of last PSA in 2003. The median follow-up time of PRFS was 20 months (range: 1–32 months). Since there have been no biochemical or clinical failures to date in the 34 evaluable patients, all PRFS times are censored (100% survival to date). Most toxicity was Grade 1–2 GU. Grade 3 GU toxicities: nocturia (3), and urinary frequency (3). No Grade 3 or higher GI toxicity occurred. Two patients experienced DVT's (one GR3 and one GR4). While receiving chemotherapy, Grade 3 toxicities included anemia (2) and leukopenia (2). Conclusions: Multi-modality therapy as described in this study was well tolerated for high-risk Pca. Although the follow-up interval is short, tumor control rates are very encouraging. Additional follow-up and patient accrual will be needed to validate these findings. Author Disclosure Employment or Leadership Consultant or Advisory Stock Ownership Honoraria Research Funding Expert Testimony Other Remuneration Aventis Pharmaceuticals