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A Randomized, Open Label, Multicenter, Phase III, 2-Arm Study of Androgen Deprivation With Leuprolide, +/- Docetaxel for Clinically Asymptomatic Prostate Cancer Subjects With a Rising PSA Following Definitive Local Therapy
The primary objective was to evaluate and compare the efficacy of androgen deprivation with or without docetaxel as determined by the median progression free survival (PFS) over the period of 18-month therapy and at least 18-month follow-up. The secondary objectives were: * To assess cancer specific survival; * To compare overall survival between the 2 treatment groups; * To evaluate patient-reported outcomes including quality of life, fatigue, and sexual functioning as measured by 3 different assessments.
Details
| Lead sponsor | Sanofi |
|---|---|
| Phase | Phase 3 |
| Status | TERMINATED |
| Enrolment | 413 |
| Start date | 2007-07 |
| Completion | 2012-09 |
Conditions
- Prostatic Neoplasms
Interventions
- Docetaxel
- Leuprolide
- Bicalutamide
Primary outcomes
- Median Progression-Free Survival (PFS) in Intent-to-treat (ITT) Population — Randomization until PSA progression or radiographic progression or death due to prostate cancer, assessed up to Month 60
PFS was the time from randomization to the date of first documented prostate specific antigen (PSA) progression, or radiographic progression, or death due to prostate cancer in the absence of previous documentation of disease progression, whichever occurred first. PSA progression was determined as: a) During treatment period: a 50 percent (%) increase from baseline, which was confirmed by a second value; b) During follow-up: detectable PSA (defined as PSA greater than or equal to 0.05 nanogram per millimeter \[ng/mL\]), which was confirmed by consecutive observation (not less than 2 weeks apart). Median PFS was estimated using the Kaplan-Meier method. - Progression-Free Survival (PFS) Rate at Month 36 in ITT Population — Month 36
PFS rate at Month 36 was defined as probability of being progression-free at Month 36. PFS rate was estimated using the Kaplan-Meier method. - Median Progression-Free Survival (PFS) in Testosterone Specific Evaluable Population — Randomization until PSA progression or radiographic progression or death due to prostate cancer, assessed up to Month 60
PFS was the time from randomization to the date of first documented PSA progression, or radiographic progression, or death due to prostate cancer in the absence of previous documentation of disease progression, whichever occurred first. Median PFS was estimated using the Kaplan-Meier method. - Progression-Free Survival (PFS) Rate at Month 36 in Testosterone Specific Evaluable Population — Month 36
PFS rate at Month 36 was defined as probability of being progression-free at Month 36. PFS rate was estimated using the Kaplan-Meier method.
Countries
United States, Belgium, Canada, Czechia, Germany, Lithuania, Poland, Slovakia, Spain