NCT06084338

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

Phase II Trial of Targeted Radiation With no Castration for Mcrpc

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: VA Office of Research and Development · Federal
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Detailed description

This is a randomized, parallel-arm, two-stage open-label phase 2 study of comprehensive metastasis directed therapy in the form of stereotactic body radiation therapy (SBRT) to all detectable sites of disease plus PSMA targeted radiopharmaceutical therapy (pluvicto), discontinuation of castration, with and without testosterone replacement therapy (TRT) in metastatic castration resistant prostate cancer (mCRPC).

Conditions

• Prostate Cancer

Interventions

Type	Name	Description
RADIATION	stereotactic ablative radiotherapy	Metastasis directed
DRUG	Pluvicto	PSMA targeted radiopharmaceutical therapy
DRUG	topical testosterone	Topical testosterone 1.62% gel

Timeline

• Start date: 2023-12-14
• Primary completion: 2027-11-29
• Completion: 2028-12-31
• First posted: 2023-10-16
• Last updated: 2025-12-31

Locations

4 sites across 1 country: United States

Regulatory

• FDA-regulated drug study