Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as Docetaxel (TAXOTERE®) Chemotherapy
Docetaxel Chemotherapy · 1 trial · 1 indication
PFS is the interval from the date of surgery to date of progression. The date of progression was the earlier of * first PSA increase to ≥ 0.4 ng/mL confirmed within two weeks * date of the nadir, if PSA nadir did not reach \< 0.4 ng/mL (for deferred arm) * first radiological/ histological evidence of tumor progression * death. Median PFS was to be estimated using Kaplan-Meier curves. However, enrollment was not met, and meaningful conclusions for efficacy or QoL could not be drawn. Median PFS could not be estimated. Reported is the number of participants with disease progression.
| Arm | Type | Description |
|---|---|---|
| Docetaxel / Leuprolide Acetate - Immediate Treatment (I-CHT) | EXPERIMENTAL | Participants administered docetaxel every three weeks (q3w) for 6 cycles in combination with leuprolide acetate every 3 months for 18 months immediately following prostatectomy. |
| Leuprolide Acetate - Immediate Treatment (I-HT) | ACTIVE_COMPARATOR | Participants administered leuprolide acetate every 3 months for 18 months immediately following prostatectomy. |
| Docetaxel / Leuprolide Acetate - Deferred Treatment (D-CHT) | EXPERIMENTAL | Participants in whom treatment was deferred from randomization until first progression - i.e. PSA progression and/or radiologically or histologically documented progression. Participants were treated with docetaxel every three weeks (q3w) for 6 cycles in combination with leuprolide acetate every 3 months for 18 months. |
| Leuprolide Acetate - Deferred Treatment (D-HT) | ACTIVE_COMPARATOR | Participants in whom treatment was deferred from randomization until first progression - i.e. PSA progression and/or radiologically or histologically documented progression. Participants were treated with with leuprolide acetate every 3 months for 18 months. |
| Name | Type | Description |
|---|---|---|
| Docetaxel (TAXOTERE®) Chemotherapy | DRUG | 75 mg/m\^2 docetaxel administered intravenously over 1 hour on Day 1 every three weeks (q3w) for 6 cycles. The first cycle was to be administered within 8 days after randomization. Corticosteroid pre-medication was mandatory. The following schedule was recommended - 8 mg Dexamethasone orally for 6 doses given - the night before chemotherapy, the morning of chemotherapy, 1 hour before docetaxel infusion, the night of chemotherapy, the morning of the day after chemotherapy and the night of the day after chemotherapy. |
| Leuprolide acetate ( ELIGARD®) Hormonal Therapy | DRUG | 22.5 mg leuprolide acetate injection administered subcutaneously (SC) every 3 months for 18 months. The first injection was to be administered within 8 days after randomization. |
Inclusion Criteria: Participants who met all of the following criteria were considered for enrollment into the study. * Pathologically confirmed adenocarcinoma of the prostate based on central pathology review. All other variants are excluded * Randomization should occur less than 120 days after p...