A Phase 1b Study of 177Lu-PSMA-617 Combined With Liver Directed Therapy in Metastatic Castration Resistant Prostate Cancer
University of California, San Francisco
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.
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 trea…
Eligibility
- Age range
- 18+ years
- Sex
- Male
- Healthy volunteers
- No
Inclusion Criteria: 1. Histologically confirmed prostate cancer. 2. Progressive disease by PCWG3 criteria at study entry. 3. Male participants who are at least 18 years of age on the day of signing informed consent. 4. Castrate level of serum testosterone at study entry (\< 50 ng/dL). Note: Participants without prior bilateral orchiectomy are required to remain on Luteinizing hormone-releasing hormone (LHRH) analogue treatment for duration of study treatment. 5. Prior progression on at least one second generation androgen signaling inhibitor including abiraterone, apalutamide, darolutamide, a…
Interventions
- Drug177Lu-PSMA-617
Given intravenously (IV)
- ProcedureAblation
Undergo ablation
- ProcedureTrans-arterial chemoembolization (TACE)
Undergo TACE
- ProcedurePositron Emission Tomography (PET)/Computerized tomography (CT)
Undergo imaging
- ProcedureTumor Biopsy
Undergo biopsy
- OtherQuestionnaire
Participant will complete questionnaire
Location
- University of California, San FranciscoSan Francisco, California