SUrGery With or Without dARolutamide in High-risk and/or Locally Advanced Prostate Cancer

PHASE2RecruitingINTERVENTIONAL
Enrollment

240

Participants

Timeline

Start Date

August 10, 2023

Primary Completion Date

February 28, 2031

Study Completion Date

February 28, 2031

Conditions
Prostate Cancer
Interventions
OTHER

Surgery alone

Radical prostatectomy with lymph node dissection will be performed.

DRUG

Peri-operative darolutamide + surgery.

"Darolutamide: 600 mg (2 tablets of 300 mg) twice daily with food, equivalent to a total daily dose of 1200 mg; for a total duration of 9 months. Darolutamide will start at day 1.~Surgery: radical prostatectomy with lymph node dissection will be performed after at least 3 months of darolutamide treatment."

Trial Locations (20)

75014

NOT_YET_RECRUITING

Hopital Paris Saint-Joseph, Paris

75018

NOT_YET_RECRUITING

Hopital Bichat - Ap-Hp, Paris

Unknown

RECRUITING

Chu Angers, Angers

RECRUITING

CHU Bordeaux, Bordeaux

RECRUITING

Institut Bergonié, Bordeaux

RECRUITING

Chu Henri Mondor, Créteil

RECRUITING

CHU Grenoble, Grenoble

RECRUITING

Hopital Claude Huriez, Lille

RECRUITING

CHU Lyon - Hôpital Edouard Herriot, Lyon

RECRUITING

Institut Paoli-Calmettes, Marseille

RECRUITING

Hopital Europeen Georges-Pompidou, Paris

RECRUITING

Hopital Pitie Salpetriere, Paris

RECRUITING

Institut Mutualiste Montsouris, Paris

RECRUITING

CHU Lyon - Sud, Pierre-Bénite

RECRUITING

Clinique La Croix Du Sud, Quint-Fonsegrives

RECRUITING

CHU Rennes, Rennes

RECRUITING

Hopital Foch, Suresnes

RECRUITING

CHU Toulouse, Toulouse

RECRUITING

Institut Universitaire Du Cancer Toulouse - Oncopole, Toulouse

RECRUITING

Chu Tours - Hopital Bretonneau, Tours

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Bayer

INDUSTRY

lead

Institut Claudius Regaud

OTHER