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ACTIVE NOT RECRUITING
NCT01952223
PHASE3

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

Sponsor: UNICANCER

View on ClinicalTrials.gov

Summary

The objective of this study is to assess the effect of neoadjuvant cabazitaxel and pelvic radiotherapy in combination with androgen deprivation therapy (ADT)-radiotherapy on clinical progression-free survival in patients with high-risk localized prostate cancer (with a stringent selection of patients with at least 2 high-risk features), in a 2 by 2 factorial trial.

Official title: A Randomized Phase III, Factorial Design, of Cabazitaxel and Pelvic Radiotherapy in Patients With Localized Prostate Cancer and High-risk Features of Relapse

Key Details

Gender

MALE

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

761

Start Date

2013-12

Completion Date

2041-07

Last Updated

2025-07-30

Healthy Volunteers

No

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

Locations (1)

Institut Gustave Roussy

Villejuif, France