OncoMatch/Clinical Trials/NCT07054346
Comparison of 177Lu-PSMA-617 and 225Ac-PSMA-617
Is NCT07054346 recruiting? Yes, currently enrolling (May 2026). This Phase 1 trial studies multiple treatments including 177 Lutetium Prostate-Specific Membrane Antigen 617 and Actinium-225 Prostate-Specific Membrane Antigen 617 for prostate cancer.
Treatment: 177 Lutetium Prostate-Specific Membrane Antigen 617 · Actinium-225 Prostate-Specific Membrane Antigen 617 — There is evidence that Actinium-225 Prostate-Specific Membrane Antigen (225Ac-PSMA) has a potentially higher level of efficacy than 177 Lutetium Prostate-Specific Membrane Antigen (177Lu-PSMA) as a radioligand therapy. This single center, pilot study will compare differences in the mechanisms of actinium-225 and lutetium-177 radioligand therapies (RLT) in participants with high or very high risk localized or locoregional prostate cancer planning on undergoing a prostatectomy.
Check if I qualifyExtracted eligibility criteria
Cancer type
Prostate Cancer
Biomarker criteria
Required: FOLH1 overexpression (SUVmax > 10 in primary tumor on PSMA PET)
Maximum Standardized Uptake Value (SUVmax) in the primary tumor greater than 10 on PSMA PET using Gallium-68 (68Ga)-PSMA-11 or piflufolastat F 18 (18F-DCFPyL).
Disease stage
Required: Stage HIGH-RISK, VERY HIGH RISK, LOCALIZED
Excluded: Stage DISTANT METASTATIC DISEASE
Grade: Gleason score of 4+5 or higher (Gleason)
High-risk disease as defined as meeting 1 or more of the 3 following criteria: 1. Gleason score of 4+5 disease or higher. 2. Pelvic nodal metastases on PSMA PET. 3. Extracapsular extension or seminal vesicle invasion on MRI. No evidence of distant metastatic disease as determined by PSMA PET. Nodal disease below the iliac bifurcation (clinical stage N1) is allowed.
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Cannot have received: prostate cancer therapy
Exception: Prior 5-alpha reductase inhibitors (e.g. finasteride, dutasteride) allowed if discontinued at least 3 weeks prior to treatment start.
Has received prior prostate cancer therapy. Prior 5-alpha reductase inhibitors (e.g. finasteride, dutasteride) allowed if discontinued at least 3 weeks prior to treatment start.
Lab requirements
Blood counts
Platelets ≥100,000/mcL, Hemoglobin ≥10 g/dL, ANC ≥1,500/mcL, all independent of transfusions or growth factors within 3 months of treatment start
Kidney function
Creatinine clearance (GFR) ≥ 60 mL/min/1.73 m^2 (Cockcroft-Gault equation)
Liver function
ALT or AST ≤3.0 x ULN; Total bilirubin ≤2 x ULN (≤3 x ULN for Gilbert's Syndrome)
Demonstrates adequate organ function as defined below: Platelets ≥100,000/mcL, independent of transfusions or growth factors within 3 months of treatment start. Hemoglobin ≥10 g/dL, independent of transfusions or growth factors within 3 months of treatment start. Absolute Neutrophil Count (ANC) ≥1,500/microliter (mcL). Creatinine clearance Glomerular filtration rate (GFR) ≥ 60 mL/min/1.73 m^2 , calculated using the Cockcroft-Gault equation. Albumin ≥2.5 g/dL. Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≤3.0 x ULN. Total bilirubin (TBIL) ≤2 x the institutional upper limit of normal (ULN). For participants with known Gilbert's Syndrome ≤3 x ULN is permitted.
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 →
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