OncoMatch/Clinical Trials/NCT07145177
177Lu-PSMA-617 With Liver Directed Therapy in Metastatic Castration Resistant Prostate Cancer
Is NCT07145177 recruiting? Yes, currently enrolling (May 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
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
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
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