OncoMatch/Clinical Trials/NCT06200103
Schedule De-Escalation of 177Lu-PSMA-617 for the Treatment of Metastatic Castrate Resistant Prostate Cancer
Is NCT06200103 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies Lutetium Lu 177 Vipivotide Tetraxetan for castration-resistant prostate carcinoma.
Treatment: Lutetium Lu 177 Vipivotide Tetraxetan — This phase II trial studies how to improve the usage of Lu 177 vipivotide tetraxetan (177Lu-prostate-specific membrane antigen \[PSMA\]-617) for treating patients with castration-resistant prostate cancer that has spread from where it first started (primary site), to other places in the body (metastatic) utilizing a treatment pause after 5 cycles of therapy versus standard continuous treatment for 6 cycles. Lutetium is a radioligand therapy (RLT). RLT uses a small molecule (in this case 177Lu-PSMA-617) that carries a radioactive component to destroy tumor cells. When lutetium is injected into the body, it attaches to the PSMA receptor found on tumor cells. After lutetium attaches to the PSMA receptor, its radiation component destroys the tumor cell. Giving 177Lu-PSMA-617 for 5 cycles versus 6 cycles may better treat patients with metastatic castrate resistant prostate cancer.
Check if I qualifyExtracted eligibility criteria
Cancer type
Prostate Cancer
Biomarker criteria
Required: FOLH1 overexpression (miPSMA score >= 2 on PET)
PSMA positive metastatic castration resistant prostate cancer (68Ga and 18F PSMA PET will be considered equivalent for eligibility), defined by molecular imaging prostate specific membrane antigen (miPSMA) score >= 2 on Mayo PET report
Required: FOLH1 imaging-defined avidity (lesions with uptake equal to or above liver on cycle 1 post therapy SPECT)
Lesions with uptake equal to or above liver on cycle 1 post therapy SPECT
Required: FOLH1 imaging-defined avidity (no lesions with SUV max above mean SUV of 2cm ROI in central right hepatic lobe (near-complete response on post-therapy SPECT))
Near-complete response on post-therapy SPECT following any of cycles 2-5 of 177Lu PSMA-617. Near-complete response will be defined as no lesions with SUV max above the mean standard uptake value (SUV) of a representative 2cm spherical region of interest in the central right hepatic lobe, as determined by a nuclear medicine trained radiologist
Required: FOLH1 imaging-defined avidity (PSMA avid lesions on PSMA PET (miPSMA score >= 2 following first progression))
PSMA avid lesions on PSMA PET (miPSMA score >= 2 following first progression)
Disease stage
Required: Stage IVB
Metastatic disease required
Lab requirements
Blood counts
Hemoglobin (Hgb) ≥ 8 g/dL; Platelets ≥ 75,000/mm^3; Neutrophils ≥ 100/mm^3
Kidney function
eGFR < 50 mL/min *BSA using Cockcroft-Gault formula OR Creatinine ≤ 1.5 x upper limit of normal
Liver function
AST or ALT ≤ 3 x upper limit of normal
Hemoglobin (Hgb) ≥ 8 g/dL; Platelets ≥ 75,000/mm^3; Neutrophils ≥ 100/mm^3; eGFR < 50 mL/min *body surface area (BSA) using Cockcroft-Gault formula OR Creatinine ≤ 1.5 x upper limit of normal; AST or ALT ≤ 3 x upper limit of normal
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Mayo Clinic in Rochester · Rochester, Minnesota
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