OncoMatch/Clinical Trials/NCT06526299
Low PSMA SUV Boost (LPS-Boost): Intensified 177Lu-PSMA-617 Treatment for Patients With Metastatic Castrate-Resistant Prostate Cancer With Low PSMA Expressing Disease
Is NCT06526299 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies Lutetium Lu 177 Vipivotide Tetraxetan for metastatic castration-resistant prostate carcinoma.
Treatment: Lutetium Lu 177 Vipivotide Tetraxetan — This phase II trial tests how well 177Lu-PSMA-617 works in treating patients with prostate cancer that has spread from where it first started (primary site) to other places in the body (metastatic) and that remains despite treatment (resistant). Lutetium Lu 177 (177Lu), the radioactive (tracer) component being delivered by prostate-specific membrane antigen (PSMA)-617, has physical properties that make it ideal radionuclide (imaging tests that uses a small dose tracer) for treatment of metastatic castrate-resistant prostate cancer (mCRPC). 177Lu-PSMA-617 works by binding to prostate cancer cells and inducing damage to deoxyribonucleic acid (DNA) inside prostate cancer cells. Giving 177Lu-PSMA-617 may improve treatment outcomes for patients with mCRPC.
Check if I qualifyExtracted eligibility criteria
Cancer type
Prostate Cancer
Biomarker criteria
Required: FOLH1 positive 68Ga-PSMA PET/CT scan with no PSMA negative lesion (68Ga-PSMA-11 uptake greater than that of liver parenchyma in one or more metastatic lesions of any size in any organ system)
Patients must have a positive 68Ga-PSMA PET/CT scan with no PSMA negative lesion, as determined by the Nuclear Medicine site investigator. The presence of PSMA-positive lesions was defined as 68Ga-PSMA-11 uptake greater than that of liver parenchyma in one or more metastatic lesions of any size in any organ system.
Required: FOLH1 whole body tumor SUVmean of < 10 on 68Ga-PSMA PET/CT scan (< 10)
Patients must have whole body tumor SUVmean of < 10 on 68Ga-PSMA PET/CT scan, as determined by the Nuclear Medicine site investigator.
Disease stage
Required: Stage IVB
Metastatic disease required
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Must have received: androgen receptor pathway inhibitor (enzalutamide, abiraterone)
Patients must have received at least one androgen receptor pathway inhibitor (ARPI) (such as enzalutamide and/or abiraterone).
Must have received: androgen deprivation therapy or orchiectomy
Patients must have prior orchiectomy and/or ongoing androgen-deprivation therapy
Cannot have received: PSMA-targeted radioligand therapy
Previous PSMA-targeted radioligand therapy is not allowed.
Cannot have received: bone-targeted radiopharmaceutical (Strontium-89, Samarium-153, Rhenium-186, Rhenium-188, Radium-223)
Exception: within 6 months prior to treatment day 1
Previous treatment with Strontium-89, Samarium-153, Rhenium-186, Rhenium-188, Radium-223 or hemi-body irradiation within 6 months prior to treatment day 1.
Cannot have received: systemic anti-cancer therapy
Exception: within 30 days prior to treatment day 1
Any systemic anti-cancer therapy (e.g. chemotherapy, immunotherapy or biological therapy [including monoclonal antibodies]) within 30 days prior to treatment day 1.
Cannot have received: investigational agent
Exception: within 30 days prior to treatment day 1
Any investigational agents within 30 days prior to treatment day 1.
Cannot have received: transfusion
Exception: within 30 days of treatment day 1
Transfusion within 30 days of treatment day 1.
Lab requirements
Blood counts
WBC ≥ 2.5 x 10^9/L OR ANC ≥ 1.5 x 10^9/L; Platelets ≥ 100 x 10^9/L; Hemoglobin ≥ 9 g/dL
Kidney function
Serum creatinine ≤ 1.5 x ULN or creatinine clearance ≥ 50 mL/min
Liver function
Total bilirubin ≤ 1.5 x ULN (≤ 3 x ULN for Gilbert's syndrome); ALT or AST ≤ 3.0 x ULN OR ≤ 5.0 x ULN for patients with liver metastases; Albumin > 3.0 g/dL
WBC count ≥ 2.5 x 10^9/L OR ANC ≥ 1.5 x 10^9/L; Platelets ≥ 100 x 10^9/L; Hemoglobin ≥ 9 g/dL; Total bilirubin ≤ 1.5 x ULN (≤ 3 x ULN for Gilbert's syndrome); ALT or AST ≤ 3.0 x ULN OR ≤ 5.0 x ULN for patients with liver metastases; Albumin > 3.0 g/dL; Serum creatinine ≤ 1.5 x ULN or creatinine clearance ≥ 50 mL/min.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- University of California San Francisco · San Francisco, California
- Olive View-University of California Los Angeles Medical Center · Sylmar, California
- Fred Hutch/University of Washington Cancer Consortium · Seattle, Washington
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