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)

Abstract

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 baselin...