Adjuvant Leuprolide With or Without Docetaxel in High Risk Prostate Cancer After Radical Prostatectomy

This is a prospective, multicenter, open-label, randomized phase III study in participants at high risk of recurrent prostate cancer after radical prostatectomy. The study will investigate * Treatment with docetaxel (TAXOTERE®) every three weeks (q3w) plus leuprolide acetate (ELIGARD®) versus leuprolide acetate alone (ELIGARD®) * Immediate treatment following prostatectomy versus deferred treatment at the time of relapse Using a 2x2 factorial design participants will therefore be randomized to * Immediate adjuvant treatment with docetaxel plus leuprolide acetate (chemotherapy and hormonal therapy) * Immediate adjuvant treatment with leuprolide acetate alone (hormonal therapy) * Deferred treatment with docetaxel plus leuprolide acetate (chemotherapy and hormonal therapy) * Deferred treatment with leuprolide acetate alone (hormonal therapy) Primary Objective: * The primary objective of the study is to compare progression-free survival using a 2x2 factorial design Secondary Objectives: * To compare the 5-year overall, cancer-specific and metastasis-free survival after systemic treatment between the groups * To compare the safety and tolerability between Docetaxel in combination with leuprolide acetate and leuprolide acetate alone. * To evaluate quality of life as measured by the FACT-P questionnaire. Originally, 1696 participants were planned in the study (with 424 participants randomized to each arm). However, only a total of 211 participants completed the randomization procedure as of 26 September 2007. Thus, sanofi-aventis, in accordance with the Steering Committee, decided to stop the participant recruitment as of 26 September 2007. Participants who had already signed their Informed Consent (IC) before September 26, 2007 were allowed to enter the randomization if they met eligibility criteria. The final revised number of planned participants to be randomly assigned to the 4 treatment arms was 250, and 228 participants were actually randomized. The final sample size did not allow all the statistical analyses to be conducted on efficacy data. Therefore, the protocol was amended to reflect the change in the plans for statistical analysis. The study was underpowered to serve as the basis for drawing conclusions regarding efficacy and quality of life (QoL) endpoints.

The study consisted of the following: * Randomization of eligible participants within 120 days of prostatectomy * For participants assigned to immediate therapy, a treatment period up to 18 months within 8 days of randomization * For participants assigned to deferred treatment, a treatment period up to 18 months after evidence of progression prior to December 2010. Participants who did not progress before December 2010 were withdrawn from the study.