177Lu-PSMA-617 with Liver Directed Therapy for Metastatic Prostate Cancer
This study is looking at men with metastatic castrate-resistant prostate cancer (mCRPC), which is prostate cancer that has spread and is no longer responding to hormone therapy. Specifically, it's for those whose cancer has spread to the liver and who have already tried at least one other hormone-blocking treatment. The study is testing the safety of combining a drug called 177Lu-PSMA-617 with treatments that target the liver, such as ablation or trans-arterial chemoembolization (TACE). Researchers will also look at how many participants respond to the treatment. About 30 men are expected to join this study, but its current status is unclear.
- Study design
- This is an open-label, single-arm study, meaning all participants receive the same treatment and everyone knows what treatment is being given. It aims to enroll 30 participants.
- What's involved
- Participants will receive 177Lu-PSMA-617 intravenously (through a vein) and undergo liver-directed therapy (ablation or TACE). They will also have imaging scans (PET/CT) and tumor biopsies.
- Compensation
- Not stated in the trial record.
- Follow-up
- Participants will be followed for up to 12 months to check for side effects and how well the treatment works.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
177Lu-PSMA-617 With Liver Directed Therapy in Metastatic Castration Resistant Prostate Cancer
At a glance
Conditions
Where it's being run
1 sites across 1 statesStudy leadership
- Rahul Aggarwal, MD · PRINCIPAL_INVESTIGATOR · University of California, San Francisco
Who to contact
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What this trial measures
- Percentage of participants with treatment emergent adverse events.up to 12 months
Treatment emergent adverse events will be classified according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) v5.0. Adverse events and clinically significant laboratory abnormalities (meeting Grade 3, 4, or 5 criteria according to CTCAE) will be summarized by maximum intensity and relationship to Lu-PSMA-617 and liver-directed therapy (if applicable). Descriptive statistics will be utilized to display the data on toxicity seen. Descriptive summaries of discrete data will present the number of study participants and the incidence as a frequency and a percentage.
- Objective response Rate (ORR)up to 12 months
ORR is defined as the proportion of treated participants who obtained an radiographic objective response \[confirmed complete response (CR) or confirmed partial response (PR) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 criteria. Proportion and 95% confidence interval will be reported.