Objectives: To evaluate the safety and efficacy of docetaxel and an abbreviated course of hormonal therapy in
patients with high risk prostate cancer after radical prostatectomy (RP) or radiation therapy (RT).
Materials and Methods: A total of 21 patients were enrolled between June 2004 and October 2005. Nine patients were
treated with RP and eleven patients with RT. High risk of disease recurrence was defined by at least one of the following:
node positive disease post-operatively, capsule involvement, seminal vesicle involvement, Gleason score ≥ 8, >50% of
core biopsies that are positive, clinical stage T2c or T3, or pre-operative PSA > 15 plus Gleason score of 7. Treatment
consisted of 3 cycles of docetaxel chemotherapy and hormonal therapy consisted of an LHRH analog (Lupron) with or
without anti-androgen therapy (Casodex) for six months.
Results: Overall, treatment was well tolerated with minimal toxicity. One patient experienced grade 4 hyperglycemia and
one patient experienced grade 3 transaminitis. At a median follow-up of 47.5 months, 7 patients (35%) have progressed.
Four-year estimated Kaplan-Meier biochemical progression free survival (KM-bPFS) was 63.7% .
Conclusions: Docetaxel and an abbreviated course of hormonal therapy after RP or RT in patients with high risk prostate
cancer is feasible and safe. The ongoing randomized phase III trial of abbreviated 6 months hormonal therapy with
radiation therapy with or without docetaxel in patients with high risk prostate cancer will elucidate the role of docetaxel
on biochemical progression-free survival and overall survival in this group of high risk patients with prostate cancer.