RecruitingMetastatic Prostate CancerProstate Cancer
177Lu-PSMA-617 With Liver Directed Therapy in Metastatic Castration Resistant Prostate Cancer
Eligible age
18+ yrs
Accepts
Men
Locations
1 state
Healthy volunteers
No
See if you qualify for this study
Answer a few quick questions about your location and health. Takes about a minute.
About this study
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.
Sponsor: University of California, San Francisco
You may qualify if…
- ✓ 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, and/or enzalutamide.
- ✓ 6. Adverse events related to prior anti-cancer treatment (excluding LHRH analogs) must have recovered to Grade ≤ 1 (except for any grade alopecia and grade ≤ 2 neuropathy).
- ✓ 7. Prior external beam radiotherapy is allowed if the last radiotherapy treatment was greater than 2 weeks from start of study treatment on Cycle 1 Day 1 (C1D1). Note: Participants must have recovered from all radiation-related toxicities. A 1-week washout is permitted for palliative radiation (≤2 weeks of radiotherapy) to non-central nervous system (CNS) disease.
- ✓ 8. At least one PSMA-avid extrahepatic lesion on screening PSMA Positron Emission Tomography (PET). A positive lesion is defined as uptake above background liver. Hepatic lesions may be PSMA PETnegative or positive.
You may not qualify if…
- ✕ 1. De novo small cell neuroendocrine prostate cancer.
- ✕ 2. One or more extrahepatic soft tissue lesions (lymph nodes \> 1.5 cm in short axis, visceral/soft tissue lesions \> 1 cm) on screening CT that is negative on PSMA PET. Non- PSMA avid liver lesions are allowed.
- ✕ 3. Recipient of other systemic anti-cancer therapies administered within 14 days, or 5 half lives, whichever is shorter, prior to initiation of study treatment. Note: LHRH analogues are the exception and are permitted
- ✕ 4. Recipient of prior PSMA-directed radioligand treatment.
- ✕ 5. Recipient of \> 2 lines of prior taxane-based chemotherapy administered in the castration-resistant setting. Prior taxane in the castration sensitive setting does not count towards this limit. If platinum chemotherapy is added to taxane this does not count as a separate line of treatment.
- ✕ 6. Previous bilio-enteric anastomosis, ampulla of Vater sphincterotomy, biliary stent, or biliary drain passing through the ampulla of Vater.
- ✕ 7. Currently participating in a study of an investigational therapeutic agent or has used an investigational device within 4 weeks prior to the first dose of study treatment on C1D1. Note: Participants who have entered the follow-up phase of an investigational study may participate as long as it has been 4 weeks after the last dose of the previous investigational agent.
- ✕ 8. Clinically significant cardiovascular disease including, but not limited to:
Where it's recruiting
California
San Francisco
Source: ClinicalTrials.gov · NCT07145177 · last updated 2026-06-01