NCT05116475View on ClinicalTrials.gov

Evaluation of dAroLutamide Addition to anDrogen Deprivation Therapy and radIatioN Therapy in Newly Diagnosed Prostate Cancer With Pelvic Lymph Nodes Metastases

PHASE3RecruitingINTERVENTIONAL
Enrollment

152

Participants

Timeline

Start Date

August 30, 2022

Primary Completion Date

February 28, 2026

Study Completion Date

February 28, 2027

Conditions
Prostate Cancer
Interventions
DRUG

Darolutamide 300 mg

Darolutamide regimen will be of 2 tablets of 300 mg orally twice daily for 24 months.

DRUG

Placebo of Darolutamide

Placebo of Darolutamide regimen will be of 2 tablets of 300 mg orally twice daily for 24 months.

Trial Locations (1)

37170

RECRUITING

Pôle Santé Léonard de Vinci, Chambray-lès-Tours

Sponsors

Collaborators (1)

Bayer
All Listed Sponsors
collaborator

Bayer

INDUSTRY

lead

Association Pour La Recherche des Thérapeutiques Innovantes en Cancérologie

OTHER

NCT05116475 - Evaluation of dAroLutamide Addition to anDrogen Deprivation Therapy and radIatioN Therapy in Newly Diagnosed Prostate Cancer With Pelvic Lymph Nodes Metastases | Biotech Hunter | Biotech Hunter