Treatment With Darolutamide +/- Radiation Therapy for Patients With a Castration Resistant Cancer and Metastases Detected by Functional Imaging

PHASE3RecruitingINTERVENTIONAL
Enrollment

336

Participants

Timeline

Start Date

October 7, 2024

Primary Completion Date

October 15, 2029

Study Completion Date

October 7, 2032

Conditions
Prostatic Cancer, Castration-Resistant
Interventions
DRUG

Darolutamide 300 mg

2 tablets of 300 mg twice daily (=1200 mg/day) up to 5 years from randomisation

RADIATION

Stereotactic body radiation therapy

Over one week,30 Gy in 3 fractions of 10 Gy

DRUG

Androgen deprivation therapy

Continuous ADT during the study course. The choice of ADT is left to the discretion of the investigator.

Trial Locations (4)

42055

RECRUITING

CHU de Saint-Etienne, Saint-Etienne

56322

RECRUITING

Groupe Hospitalier Bretagne Sud, Lorient

94805

RECRUITING

Gustave Roussy Cancer Campus, Villejuif

06250

RECRUITING

Centre Azuréen de Cancérologie, Mougins

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Bayer

INDUSTRY

lead

UNICANCER

OTHER

NCT06276465 - Treatment With Darolutamide +/- Radiation Therapy for Patients With a Castration Resistant Cancer and Metastases Detected by Functional Imaging | Biotech Hunter | Biotech Hunter