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RECRUITING
NCT07476001
PHASE2

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

Sponsor: H. Lee Moffitt Cancer Center and Research Institute

View on ClinicalTrials.gov

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.

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

Key Details

Gender

MALE

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

12

Start Date

2026-03

Completion Date

2027-09

Last Updated

2026-03-17

Healthy Volunteers

No

Interventions

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.

Locations (1)

Moffitt Cancer Center

Tampa, Florida, United States