RecruitingPhase 2NCT07476001

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


Sponsor

H. Lee Moffitt Cancer Center and Research Institute

Enrollment

12 participants

Start Date

Mar 1, 2026

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Sex: MALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This trial is testing a two-step treatment approach for men with advanced prostate cancer that has stopped responding to hormone therapy (called metastatic castration-resistant prostate cancer, or mCRPC). First, patients receive a high dose of testosterone (which may briefly make cancer cells more vulnerable), followed by a radioligand therapy called PSMA-617 that delivers radiation directly to cancer cells. **You may be eligible if...** - You have advanced prostate cancer that has progressed despite hormone suppression therapy - Your cancer shows up on a PSMA PET scan (a special imaging test) - You have already received one type of hormone-blocking drug (ARPI) - You have mild or no cancer-related symptoms - You are in good general health (ECOG 0–1) - Your heart function is adequate **You may NOT be eligible if...** - Your cancer has spread to the spine covering (epidural), liver, or brain - You have had radiation therapy in the last 30 days - You have an active uncontrolled infection, heart problems, or other serious illness - You are currently on another experimental treatment Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGTestosterone cypionate (Tc)

IM injection of Tc at 400 mg (Tc400) every 28 days for up to 3 doses.

DRUGADT 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.

DRUGPSMA-617

IV at 7.4GBq (200mCi) once every 6 weeks for up to 6 doses.


Locations(1)

Moffitt Cancer Center

Tampa, Florida, United States

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NCT07476001


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