A Phase III of Cabazitaxel and Pelvic Radiotherapy in Localized Prostate Cancer and High-risk Features of Relapse

PHASE3Active, not recruitingINTERVENTIONAL
Enrollment

761

Participants

Timeline

Start Date

December 31, 2013

Primary Completion Date

December 31, 2025

Study Completion Date

July 31, 2041

Conditions
Adenocarcinoma of ProstateProgression of Prostate Cancer
Interventions
DRUG

Cabazitaxel

Cabazitaxel administered at 25 mg/m² as a 1 hour intravenous infusion every 3 weeks (1 cycle = 21 days) for 4 cycles

RADIATION

Pelvic radiotherapy

"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"

RADIATION

prostate radiotherapy

"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"

Trial Locations (1)

F-94805

Institut Gustave Roussy, Villejuif

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Sanofi

INDUSTRY

lead

UNICANCER

OTHER

NCT01952223 - A Phase III of Cabazitaxel and Pelvic Radiotherapy in Localized Prostate Cancer and High-risk Features of Relapse | Biotech Hunter | Biotech Hunter