NCT07142551 - Supraphysiologic Testosterone Priming Induces Darolutamide Extended Response | Biotech Hunter

Enrollment

Participants

Timeline

Start Date

October 30, 2025

Primary Completion Date

June 1, 2030

Study Completion Date

June 1, 2034

Conditions

Metastatic Castration-resistant Prostate Cancer

Interventions

DRUG

Testosterone cypionate

Intermittent intramuscular testosterone cypionate (T) at a dose of 400 mg every 4 weeks.

DRUG

Luteinizing hormone-releasing hormone (LHRH) analogue

Eligible patients will initiate combined androgen deprivation therapy (ADT) with an LHRH agonist or antagonist (e.g. Eligard, Zoladex, Lupron, Orgovyx) in combination with standard dose darolutamide (600 mg twice daily) for a total of 6 months.

DRUG

Darolutamide

600 mg twice daily during the lead-in phase and on darolutamide cycle.

Trial Locations (1)

21205

Johns Hopkins Sidney Kimmel Comprehensive Cancer Center, Baltimore