RecruitingPhase 2NCT06084338

Randomized Phase II Trial of Targeted Radiation With no Castration for Mcrpc

Phase II Trial of Targeted Radiation With no Castration for Mcrpc


Sponsor

VA Office of Research and Development

Enrollment

60 participants

Start Date

Dec 14, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

This trial tests if the combination of comprehensive metastasis directed therapy delivered by a precision form of external beam radiotherapy (stereotactic ablative radiotherapy), combined with PSMA targeted radiopharmaceutical therapy and cessation of castration, and then followed by testosterone replacement, is an effective treatment for metastatic castration resistant prostate cancer. All patients will be treated with stereotactic ablative radiotherapy and PSMA targeted radiopharmaceutical therapy with cessation of castration. Half of patients are randomized to either receive, or not receive, subsequent testosterone replacement.


Eligibility

Sex: MALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests whether targeted radiation therapy (called SBRT) to all visible cancer sites — without continued hormone therapy (castration) — can treat castration-resistant prostate cancer that has spread to a limited number of sites. This approach may allow some patients to avoid ongoing hormonal side effects. **You may be eligible if...** - You are 18 or older with castration-resistant prostate cancer (cancer growing despite very low testosterone) - Your cancer has spread to no more than 10 sites visible on PSMA PET and FDG PET scans - Your cancer has progressed despite prior hormone-blocking drugs - Your overall health is adequate (ECOG 0-2) - Your blood counts and organ function are within acceptable ranges **You may NOT be eligible if...** - Your cancer has spread to the liver or brain (lung metastases are allowed) - Your tumor type is small cell or neuroendocrine carcinoma - You have a visceral organ metastasis to the liver - You have current spinal cord compression or urgent need for palliative radiation - You have active infection requiring antibiotics - You have a psychiatric or substance abuse condition that could interfere with participation 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

RADIATIONstereotactic ablative radiotherapy

Metastasis directed

DRUGPluvicto

PSMA targeted radiopharmaceutical therapy

DRUGtopical testosterone

Topical testosterone 1.62% gel


Locations(4)

VA Greater Los Angeles Healthcare System, West Los Angeles, CA

West Los Angeles, California, United States

Edward Hines Jr. VA Hospital, Hines, IL

Hines, Illinois, United States

Richard L. Roudebush VA Medical Center, Indianapolis, IN

Indianapolis, Indiana, United States

VA Ann Arbor Healthcare System, Ann Arbor, MI

Ann Arbor, Michigan, United States

View Full Details on ClinicalTrials.gov

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NCT06084338


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