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Phase 2a Study of High-Dose Testosterone Followed by Radioligand Therapy in mCRPC
Sponsor: H. Lee Moffitt Cancer Center and Research Institute
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
Testosterone cypionate (Tc)
IM injection of Tc at 400 mg (Tc400) every 28 days for up to 3 doses.
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.
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