A Prospective Randomized Phase III Study Comparing Hormonal Therapy +/-Docetaxel
Status:
Unknown status
Trial end date:
2010-11-01
Target enrollment:
Participant gender:
Summary
The primary objective was to evaluate the PSA (biochemical) progression-free survival (PFS)
of high-risk metastasis-free PC patients, treated with LH-RH agonist for one year with or
without docetaxel after prior radical prostatectomy (RP) or radiotherapy (RT).
The study was powered at 80% to detect a 25% improvement in biochemical PFS for a total
sample size estimated at 252 patients, with a two-sided type I error rate of 5%
(non-parametric methods.
Phase:
Phase 3
Details
Lead Sponsor:
Assistance Publique - Hôpitaux de Paris
Collaborator:
ARTIC group (oncologists and urologists association)