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...
Docetaxel Chemotherapy is used in prostate cancer, specifically in a Phase 3 trial for high-risk prostate cancer after radical prostatectomy. The trial evaluated adjuvant leuprolide with or without docetaxel. Docetaxel is a small molecule chemotherapy agent in the oncology therapeutic area.
Docetaxel Chemotherapy targets tubulin proteins, including TUBB4B, TUBB1, TUBA3C, TUBA4A, TUBB3, and TUBA1A. It acts as an inhibitor of these targets, which are components of microtubules. This mechanism disrupts microtubule dynamics, leading to cell cycle arrest and cell death in cancer cells.
Docetaxel Chemotherapy is developed by Sanofi, which trades under the ticker SNY. Sanofi is the company associated with the development of this chemotherapy agent.
Docetaxel Chemotherapy is in Phase 3 development. It is an investigational therapy and has been studied in a completed Phase 3 clinical trial. It is not stated to be approved for the specific indication of high-risk prostate cancer after radical prostatectomy.
Docetaxel Chemotherapy has been studied in a Phase 3 clinical trial, NCT00283062, titled "Adjuvant Leuprolide With or Without Docetaxel in High Risk Prostate Cancer After Radical Prostatectomy." This trial is completed and enrolled 228 male participants aged 18 years and older across multiple countries.
Yes, Docetaxel Chemotherapy is also known as Docetaxel (TAXOTERE®) Chemotherapy. TAXOTERE is a registered trademark name for docetaxel. Both names refer to the same chemotherapy agent developed by Sanofi.