A Study of Androgen Deprivation With Leuprolide, +/- Docetaxel for Clinically Asymptomatic Prostate Cancer Participants With a Rising Prostate Specific Antigen (PSA)

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

Population: ITT population included all participants who were randomized, with study drug assignment designated according to randomization, regardless of whether participants received any study drug or a different drug from that to which they were randomized.

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

Population: Testosterone-specific evaluable population included all participants who recovered testosterone to non-castrate levels (50 ng/mL) following the completion of treatment of leuprolide with at least 1 follow-up PSA assessment.

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

Population: 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

Population: Testosterone-specific evaluable population included all participants who recovered testosterone to non-castrate levels (50 ng/mL) following completion of treatment of leuprolide with at least 1 follow-up PSA assessment.

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

Population: ITT population.

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)

Population: ITT population. Here N (number of participants analyzed) signifies participants who were evaluable for this measure and n signifies participants evaluable at each time-point for each treatment arm, respectively.

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)

Population: ITT population. Here N (number of participants analyzed) signifies participants who were evaluable for this measure and n signifies participants evaluable at each time-point for each treatment arm, respectively.

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)

Population: ITT population. Here N (number of participants analyzed) signifies participants who were evaluable for this measure and n signifies participants evaluable at each time-point for each treatment arm, respectively.

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)

Population: ITT population. Here N (number of participants analyzed) signifies participants who were evaluable for this measure and n signifies participants evaluable at each time-point for each treatment arm, respectively.

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

Population: ITT population.

TEAE: any adverse event (AE) that occurred or worsened during the on-treatment period, which was the period from first administration of study treatment until 30 days after last administration of study treatment. AE: any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Serious AE: an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly, or medically important. Drug-related AEs were any untoward medical occurrences attributed to study drug in a participant who received study drug. National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 3.0 Grade 3 (severe) and Grade 4 (life threatening/disabling) TEAEs were also reported.

Time frame: From first administration of study treatment until 30 days after the last administration of study treatment

Population: Safety population included all randomized participants who received at least part of one dose of any of the study drugs.