Study of Radiation Therapy in Combination With Darolutamide + Degarelix in Intermediate Risk Prostate Cancer

PHASE2Not yet recruitingINTERVENTIONAL
Enrollment

208

Participants

Timeline

Start Date

July 2, 2024

Primary Completion Date

December 31, 2028

Study Completion Date

December 31, 2028

Conditions
Prostate Cancer
Interventions
DRUG

Darolutamide

Darolutamide will be administered orally as a tablet. Total daily dose is 1200 mg (2 tablets of 300 mg taken twice daily) for 6 months.

DRUG

Degarelix

Degarelix is administered by subcutaneous injection. The first dose of degarelix is 240 mg followed by monthly doses of 80 mg for a total treatment duration of 6 months.

RADIATION

Radiation Therapy

The total radiotherapy dose for all subjects will be: 36.25 Gy in 5Fx. The study will not include elective nodal irradiation. Every fraction will have 3D image guidance (i.e. cone-beam CT).

Trial Locations (1)

M5G 2M9

UHN Princess Margaret Hospital, Toronto

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Prostate Cancer Canada

OTHER

collaborator

Bayer

INDUSTRY

lead

University Health Network, Toronto

OTHER