OncoMatch/Clinical Trials/NCT07145177
177Lu-PSMA-617 With Liver Directed Therapy in Metastatic Castration Resistant Prostate Cancer
Is NCT07145177 recruiting? Yes, currently enrolling (Jun 2026). This Phase 1 trial studies 177Lu-PSMA-617 for metastatic prostate cancer.
Treatment: 177Lu-PSMA-617 — 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.
Check if I qualifyExtracted eligibility criteria
Treatments studied
Radioligand therapy
Cancer type
Prostate Cancer
Biomarker criteria
Required: FOLH1 PSMA-avid lesion on PET (uptake above background liver)
At least one PSMA-avid extrahepatic lesion on screening PSMA Positron Emission Tomography (PET). A positive lesion is defined as uptake above background liver.
Disease stage
Metastatic disease required
Performance status
ECOG OR KARNOFSKY 0–2
Demographics
Prior therapy
Must have received: androgen signaling inhibitor (abiraterone, apalutamide, darolutamide, enzalutamide) — castration-resistant
Prior progression on at least one second generation androgen signaling inhibitor including abiraterone, apalutamide, darolutamide, and/or enzalutamide.
Cannot have received: PSMA-directed radioligand treatment
Recipient of prior PSMA-directed radioligand treatment.
Cannot have received: taxane-based chemotherapy
Exception: No more than 2 lines 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.
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.
Lab requirements
Blood counts
Absolute neutrophil count ≥ 1,500/mcL; Platelets ≥ 100,000/mcL; Hemoglobin > 9.0 g/dL
Kidney function
Creatinine clearance (GFR) ≥ 30 mL/min/1.73 m2, calculated using Cockcroft-Gault or 24 hour urine collection
Liver function
Total bilirubin ≤ 1.5 x ULN (Gilbert's: direct bilirubin ≤ ULN); AST/SGOT ≤ 5 x ULN; ALT/SGPT ≤ 5 x ULN; Albumin ≥ 2.8 g/dL; Prothrombin time ≤ 1.5 x ULN (unless on medical therapy known to prolong prothrombin time)
Demonstrates adequate organ function as defined below: ... (see full details above)
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- University of California, San Francisco · San Francisco, California
Showing up to 5 US sites.
See all sites on ClinicalTrials.gov →Frequently asked questions
Is NCT07145177 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior PSMA-directed radioligand treatment, taxane-based chemotherapy disqualifies patients from enrollment.
Does this trial require FOLH1?
Yes, FOLH1 PSMA-avid lesion on PET is a required biomarker for enrollment.
Is this trial open to female patients?
No. This trial enrolls male patients only.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
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