Adjuvant Leuprolide With or Without Docetaxel in High Risk Prostate Cancer After Radical Prostatectomy
Status:
Completed
Trial end date:
2010-12-01
Target enrollment:
Participant gender:
Summary
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.