NCT07476001

Phase 2a Study of High-Dose Testosterone Followed by Radioligand Therapy in mCRPC

A Phase 2a Study of High Dose Testosterone Followed by Targeted Radioligand Therapy in Metastatic Castration Resistant Prostate Cancer

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 12 (estimated)
• Sponsor: H. Lee Moffitt Cancer Center and Research Institute · Academic / Other
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate whether high-dose testosterone followed by targeted radioligand therapy (TRT) is effective in treating metastatic castration resistant prostate cancer. Participants will be asked to spend about 6 months in this study. Participants will take study drug for 3.5 months.

Conditions

• Metastatic Castration-resistant Prostate Cancer

Interventions

Type	Name	Description
DRUG	Testosterone cypionate (Tc)	IM injection of Tc at 400 mg (Tc400) every 28 days for up to 3 doses.
DRUG	ADT with Luteinizing hormone-releasing hormone (LHRH) analog	Continuing ADT with either surgical castration or chemical castration with LHRH analog is considered standard of care for mCRPC.
DRUG	PSMA-617	IV at 7.4GBq (200mCi) once every 6 weeks for up to 6 doses.

Timeline

• Start date: 2026-03-01
• Primary completion: 2027-09-01
• Completion: 2027-09-01
• First posted: 2026-03-17
• Last updated: 2026-03-17

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study