Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01952223 | A Phase III of Cabazitaxel and Pelvic Radiotherapy in Localized Prostate Cancer and High-risk Features of Relapse | PHASE3 | ACTIVE NOT_RECRUITING | 761 | — | — | Dec 1, 2013 | Jul 1, 2041 | Jul 30, 2025 | 1 | France |
| Arm | Type | Description |
|---|---|---|
| ADT + pelvic RT | EXPERIMENTAL | ADT for a total duration of 3 years i.e. luteinizing hormone-releasing hormone (LHRH) agonist or LHRH antagonist +/-Peripheral anti-androgen Pelvic RT (by IMRT or IGRT protocol): * Phase 1: pelvic radiotherapy (prostate, seminal vesicles, ilio-obturator, presacral lymph nodes) (46 or 50 Gy according to the center) * Phase 2: prostate-only boost (EBRT) up to 74-78 Gy |
| ADT + Cabazitaxel + prostate RT | EXPERIMENTAL | ADT Cabazitaxel: 4 CT cycles Prostate-only RT (IMRT or IGRT): * Phase 1: prostate + seminal vesicle radiotherapy (46 or 50 Gy according to the center) * Phase 2: prostate-only boost (EBRT) up to 74-78 Gy |
| ADT + cabazitaxel + pelvic RT | EXPERIMENTAL | ADT Cabazitaxel: 4 CT cycles Pelvic RT (IMRT or IGRT): * Phase 1: pelvic radiotherapy (prostate, seminal vesicles, ilio-obturator, presacral lymph nodes) (46 or 50 Gy according to the center) * Phase 2: prostate-only boost (EBRT) up to 74-78 Gy |
| ADT + prostate radiotherapy | ACTIVE_COMPARATOR | ADT for a total duration of 3 years: LHRH agonist or LHRH antagonist +/- anti-androgen Prostate-only RT (IMRt or IGRT): * Phase 1: prostate + seminal vesicle radiotherapy (46 or 50 Gy according to the center) * Phase 2: prostate-only boost (EBRT) up to 74-78 Gy |
| Name | Type | Description |
|---|---|---|
| Cabazitaxel | DRUG | Cabazitaxel administered at 25 mg/m² as a 1 hour intravenous infusion every 3 weeks (1 cycle = 21 days) for 4 cycles |
| Pelvic radiotherapy | RADIATION | Prostate+pelvic RT (2 Gy fractions, 5 times per week): * Phase 1: pelvic radiotherapy (prostate, seminal vesicles, ilio-obturator, presacral lymph nodes) (46 or 50 Gy according to the center) * Phase 2: prostate-only boost (EBRT) up to 74-78 Gy |
| prostate radiotherapy | RADIATION | Prostate-only RT (2 Gy fractions, 5 times per week): * Phase 1: prostate + seminal vesicle radiotherapy (46 or 50 Gy according to the center) * Phase 2: prostate-only boost (EBRT) up to 74-78 Gy |
Inclusion Criteria: 1. Any T histologically confirmed adenocarcinoma of the prostate 2. No clinically or radiologically suspected metastases, including no enlarged pelvic lymph nodes (\> 1 cm in small diameter) 3. Gleason score ≥ 6 4. Meets at least 2 of the following criteria for high-risk: * ...