Multicenter phase II study of combined neoadjuvant docetaxel and hormone therapy before radical prostatectomy for patients with high risk localized prostate cancer.

PURPOSE We assessed pathological outcomes as well as the feasibility of combined docetaxel and androgen deprivation therapy in men with prostate cancer before undergoing prostatectomy. MATERIALS AND METHODS In this phase II multicenter study of newly diagnosed patients with untreated clinically localized prostate cancer and high risk features, all patients received androgen deprivation therapy (6.3 mg buserelin acetate every 8 weeks for 3 doses and antiandrogen for 4 weeks) with docetaxel (35 mg/m(2) weekly for 6 of 8 weeks for 3 doses). RESULTS A total of 72 men with a median age of 59 years (range 46 to 78) were enrolled in the study. Baseline characteristics included clinical stage T1C, T2 or T3 in 14%, 47% and 39%, and Gleason score 7 or less, 8 and 9 in 40%, 29% and 31% of patients, respectively. Median baseline prostate specific antigen was 10.8 mug/l (range 1.6 to 65.6). Eight patients did not complete protocol therapy because of toxicity (4), withdrawal of consent (1) and other reasons (3). Of the 64 patients completing protocol therapy 2 had a complete pathological response. Pathological stage was T2 in 53% and T3 in 44% of patients. Four patients had N1 disease and positive surgical margins were identified in 27%. At a median followup of 42.7 months (range 25.6 to 65.6) 19 patients (30%) had disease relapse. CONCLUSIONS Combined androgen deprivation and docetaxel before prostatectomy was feasible, and resulted in encouraging recurrence-free survival. While pathological down staging was observed, pathological complete response rates were rare.