NCT07145177

177Lu-PSMA-617 With Liver Directed Therapy in Metastatic Castration Resistant Prostate Cancer

A Phase 1b Study of 177Lu-PSMA-617 Combined With Liver Directed Therapy in Metastatic Castration Resistant Prostate Cancer

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: University of California, San Francisco · Academic / Other
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is an open label, single arm, phase 1b study to determine the safety of combining sequential Prostate-Specific Membrane Antigen (PSMA)-targeted 177Lu-PSMA-617 radionuclide therapy with liver-directed therapy in metastatic castrate-resistant prostate cancer (mCRPC) patients with liver metastases amenable to liver-directed therapy who have progressed on at least one prior androgen pathway inhibitor.

Detailed description

PRIMARY OBJECTIVES: I. To characterize the safety profile of 177Lu-PSMA-617 in combination with liver-directed therapy. II. To determine the investigator-assessed objective response rate per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 criteria in patients with mCRPC treated with 177LuPSMA-617 and liver-directed therapy. SECONDARY OBJECTIVES: I. To determine the median radiographic progression-free survival per PCWG3 criteria in patients with mCRPC treated with 177Lu-PSMA-617 and liver-directed therapy. II. To determine the median overall survival in patients with mCRPC treated with 177Lu-PSMA-617 and liver-directed therapy. III. To determine the median investigator-assessed duration of objective response per RECIST 1.1 criteria in patients with mCRPC treated with 177Lu-PSMA-617 and liver-directed therapy. IV. To determine the investigator-assessed hepatic disease response rate (HDRR) per RECIST 1.1 in patients with mCRPC treated with 177Lu-PSMA-617 and liver-directed therapy. V. To determine the investigator-assessed hepatic disease control rate (HDCR) at 6 months per RECIST 1.1 in patients with mCRPC treated with 177Lu-PSMA-617 and liver-directed therapy. VI. To determine the PSA response rate by Prostate Cancer Clinical Trials Working Group 3 (PCWG3) criteria for participants with 50% decline (PSA50) and participants with a 90% decline (PSA90) at any time point on study, as well as individually following each dose of 177Lu-PSMA-617 or liver-directed therapy. OUTLINE: Participants will receive treatment with 177Lu-PSMA-617 for up to six total cycles every 6 weeks. Participants with one or more PSMA-negative liver lesions with a single session of liver-directed therapy prior to initiation of study drug. Participants will be follow-up every 3 months up to 5 years after the last study treatment.

Conditions

• Metastatic Prostate Cancer
• Prostate Cancer

Interventions

Type	Name	Description
DRUG	177Lu-PSMA-617	Given intravenously (IV)
PROCEDURE	Ablation	Undergo ablation
PROCEDURE	Trans-arterial chemoembolization (TACE)	Undergo TACE
PROCEDURE	Positron Emission Tomography (PET)/Computerized tomography (CT)	Undergo imaging
PROCEDURE	Tumor Biopsy	Undergo biopsy
OTHER	Questionnaire	Participant will complete questionnaire

Timeline

• Start date: 2026-03-16
• Primary completion: 2028-10-31
• Completion: 2030-10-31
• First posted: 2025-08-28
• Last updated: 2026-03-23

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study