Randomized Phase II Trial on Short Term Darolutamide Concomitant to Radiation Therapy for Patients With Intermediate Unfavorable Risk Prostate Cancer

"Darolutamide will be taken orally at a fixed dose of 600 mg twice daily (1200 mg), on a continuous basis, for a maximum of 6 months. Darolutamide will start at Day 1.~\- External Beam Radiotherapy (EBRT) will start two months after treatment initiation. All patients will be treated with standard schedules:~* 78 Gy with classical 2 Gy/fractions, 5 days/7~* Or 60 Gy with 3 Gy/fractions, 5 days/7~* Use of IMRT and IGRT is mandatory~* Clinical Target Volume Definition according to GETUG Guidelines~* Organ at risk dose constraints according to RECORAD"

"Treatment by Androgen Deprivation Therapy (ADT) will be prescribed as per market authorization and following investigator judgement. ADT treatment will consist on:~* Either LH-RH agonist injection given every 3 months for 6 months, or once for 6 months,~* Either LH-RH antagonist given monthly for 6 months~External Beam Radiotherapy (EBRT) will start two months after treatment initiation. All patients will be treated by high dose irradiation in stereotactic conditions:~* 78 Gy with classical 2 Gy/fractions, 5 days/7~* Or 60 Gy with 3 Gy/fractions, 5 days/7~* Use of IMRT and IGRT is mandatory~* Clinical Target Volume Definition according to GETUG Guidelines~* Organ at risk dose constraints according to RECORAD"