OncoMatch/Clinical Trials/NCT07054346
Comparison of 177Lu-PSMA-617 and 225Ac-PSMA-617
Is NCT07054346 recruiting? Yes, currently enrolling (Sep 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
Treatments studied
Other
Cancer type
Prostate Cancer
Biomarker criteria
Required: PSMA (FOLH1) expression (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).
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Demographics
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.
Cannot have received: external beam radiation therapy to the prostate or prostate bed
Prior external beam radiation therapy (EBRT) to the prostate or prostate bed.
Lab requirements
Blood counts
Platelets ≥100,000/mcL, Hgb ≥10 g/dL, ANC ≥1,500/mcL, Albumin ≥2.5 g/dL
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)
Platelets ≥100,000/mcL, Hgb ≥10 g/dL, ANC ≥1,500/mcL, Albumin ≥2.5 g/dL, Creatinine clearance (GFR) ≥ 60 mL/min/1.73 m^2, ALT or AST ≤3.0 x ULN, Total bilirubin ≤2 x ULN (≤3 x ULN for Gilbert's Syndrome)
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 NCT07054346 currently recruiting?
Yes, this trial is currently recruiting patients.
Can patients have received prior systemic therapy?
No. This trial requires treatment-naive patients — prior systemic therapy is an exclusion criterion.
Does this trial require FOLH1?
Yes, FOLH1 expression 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.
Check if I qualify