Conditions: Prostatic Neoplasms
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 413
Healthy volunteers: no

Brief summary:
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.

Detailed description:
The duration of the study per participant was to be at least 36 months, of which the treatment period was 18 months for all participants, followed by at least 18 months follow-up period.

Participants received study treatment for up to 18 months from the time of study therapy initiation or less if one of the following occurred: disease progression, unacceptable toxicity, death, participant refusal or treatment delay beyond the time frame that is permitted for each treatment.

Arms:
arm 1: Participants received docetaxel 75 milligram per square meter (mg/m\^2) intravenous infusion over 1 hour every 3 weeks up to 10 cycles (3 week cycle) along with leuprolide 22.5 mg injection subcutaneously every 12 weeks up to 18 months and bicalutamide 50 mg tablet orally once daily for first 4 weeks of treatment. arm 2: Participants received leuprolide 22.5 mg injection subcutaneously every 12 weeks up to 18 months and bicalutamide 50 mg tablet orally once daily for first 4 weeks of treatment.

Interventions: intervention 1: Docetaxel intervention 2: Leuprolide intervention 3: Bicalutamide
Intervention descriptions: intervention 1: 75 mg/m\^2 intravenous infusion over 1 hour every 3 weeks up to 10 cycles. intervention 2: 22.5 mg injection subcutaneously every 12 weeks up to 18 months. intervention 3: 50 mg tablet orally once daily for first 4 weeks of treatment.

Protocol document: