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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
413
75 mg/m\^2 intravenous infusion over 1 hour every 3 weeks up to 10 cycles.
22.5 mg injection subcutaneously every 12 weeks up to 18 months.
50 mg tablet orally once daily for first 4 weeks of treatment.
Sanofi-Aventis Administrative Office
Bridgewater, New Jersey, United States
Sanofi-Aventis Administrative Office
Diegem, Belgium
Sanofi-Aventis Administrative Office
Laval, Canada
Sanofi-Aventis Administrative Office
Prague, Czechia
Sanofi-Aventis Administrative Office
Frankfurt, Germany
Sanofi-Aventis Administrative Office
Vilnius, Lithuania
Sanofi-Aventis Administrative Office
Warsaw, Poland
Sanofi-Aventis Administrative Office
Bratislava, Slovakia
Sanofi-Aventis Administrative Office
Barcelona, Spain
Median Progression-Free Survival (PFS) in Intent-to-treat (ITT) Population
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.
Time frame: Randomization until PSA progression or radiographic progression or death due to prostate cancer, assessed up to Month 60
Progression-Free Survival (PFS) Rate at Month 36 in ITT Population
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.
Time frame: Month 36
Median Progression-Free Survival (PFS) in Testosterone Specific Evaluable Population
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.
Time frame: Randomization until PSA progression or radiographic progression or death due to prostate cancer, assessed up to Month 60
Progression-Free Survival (PFS) Rate at Month 36 in Testosterone Specific Evaluable Population
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.
Time frame: Month 36
Overall Survival (OS): Number of Participants Who Died (All Cause)
The OS was the time interval from the date of randomization to the date of death due to any cause. OS was to be analyzed using the Kaplan-Meier method. However, the analysis was not performed due to insufficient number of events. Reported is the number of participants who died from any cause.
Time frame: Randomization until death due to any cause, assessed up to Month 60
Cancer-Specific Survival: Number of Participants Who Died (Cancer-Specific)
The cancer-specific survival was the time from the date of randomization to the date of death due to prostate cancer. Cancer-specific survival was to be analyzed using the Kaplan-Meier method. However, the analysis was not performed due to insufficient number of events. Reported is the number of participants who died from prostate cancer.
Time frame: Randomization until death due to prostate cancer, assessed up to Month 60
Change From Baseline in Functional Assessment of Cancer Therapy-Prostate (FACT-P) Total Score at End of Treatment (EOT)
FACT-P is a 39-item participant questionnaire which assesses physical well-being (7 items), social/family well-being (7 items), emotional well-being (6 items), functional well-being (7 items), and additional prostate cancer specific concerns (12 items). All items are scored from 0 (not at all) to 4 (very much). The total FACT-P score ranges from 0-156, with higher scores representing a better quality of life with fewer symptoms. A score of 156 represents the best outcome.
Time frame: Baseline, EOT (up to Month 18)
Change From Baseline in Functional Assessment of Cancer Therapy-Prostate (FACT-P) Trial Outcome Index (TOI) Score at EOT
Physical well-being, functional well-being, and prostate cancer concerns sub-scales of the FACT-P questionnaire were combined to calculate TOI. Total TOI score ranges from 0 to 104, with higher scores representing a better quality of life with fewer symptoms.
Time frame: Baseline, EOT (up to Month 18)
Change From Baseline in Multidimensional Assessment of Fatigue (MAF) Index Score at EOT
MAF scale consists of 16-items to measure 4 dimensions of fatigue during past week: severity (Item 1-2), distress (Item 3), degree of interference in activities of daily living (Item 4-14), and timing (Item 15-16). Item 1-14 are scored on a numeric rating scale from 1 to 10, where higher score indicate more severity/distress/interference. Item 15-16 had multiple choice responses (4 responses each). Scale Index was calculated using Item 1-15, in following steps: 1) Item 15 score converted to 1-10 scale by multiplying the score with 2.5; 2) Average score was calculated from Item 4-14; 3) Finally scale index was calculated by adding Items 1, 2, 3 scores with average score from step 2 and converted score of Item 15 from step 1. Total MAF scale index score ranges 1 (no fatigue) to 50 (severe fatigue).
Time frame: Baseline, EOT (up to Month 18)
Change From Baseline in Erectile Function Domain of International Index of Erectile Function (EF-IIEF) Total Score at EOT
EF-IIEF is a 6-item erectile function domain of IIEF. It consists of Question 1, 2, 3, 4, 5, and 15 of IIEF questionnaire. 5 questions are scored from 0 (no activity) to 5 (very high activity) and 1 question is scored from 1 (very low activity) to 5 (very high activity). Total EF-IIEF score ranges from 1 to 30, where higher score indicates high activity.
Time frame: Baseline, EOT (up to Month 18)
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