OncoMatch/Clinical Trials/NCT06972628
Treatment of Patients With Progressive mCRPC With 177Lu-PSMA-617
Is NCT06972628 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies Administering Lutetium-177-PSMA-617 (PLUVICTO) for metastatic castration-resistant prostate cancer.
Treatment: Administering Lutetium-177-PSMA-617 (PLUVICTO) — The purpose of this study is to evaluate the safety and tolerability of Lutetium-177-PSMA-617 (PLUVICTO) in patients with metastatic castration-resistant prostate cancer (mCRPC) and extensive bone metastases, which appear as a "super scan" pattern on a bone scan. Pluvicto is FDA-approved, but patients with super scan bone scans were previously excluded from the VISION clinical trial, leaving a knowledge gap. The study will enroll up to 30 men with metastatic castration-resistant prostate cancer, with an initial dosing approach that differs from the standard dose. The safety and tolerability of PLUVICTO will be evaluated in this study, with a focus on identifying the optimal dose for this population. This study addresses an important gap in understanding how Pluvicto performs in mCRPC patients with super scan findings.
Check if I qualifyExtracted eligibility criteria
Cancer type
Prostate Cancer
Biomarker criteria
Required: FOLH1 PSMA-positive lesion on PET/CT
Positive PSMA PET/CT scan showing at least one PSMA-positive metastatic lesion
Required: AR castrate-level testosterone (<50 ng/dL or <1.7 nmol/L)
Castrate-level serum/plasma testosterone (<50 ng/dL or <1.7 nmol/L)
Disease stage
Metastatic disease required
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Must have received: androgen receptor-axis-targeted therapy
Prior treatment with at least one androgen receptor-axis-targeted therapy (ARAT)
Cannot have received: radiopharmaceutical (Strontium-89, Samarium-153, Rhenium-186, Rhenium-188, Radium-223, hemi-body irradiation)
Exception: allowed if >6 months before start of treatment
Prior treatment with radiopharmaceuticals (e.g., Strontium-89, Samarium-153, Rhenium-186, Rhenium-188, Radium-223, hemi-body irradiation) within six months before start of treatment under this protocol
Cannot have received: PSMA-targeted radioligand therapy
Prior PSMA-targeted radioligand therapy
Cannot have received: systemic anti-cancer therapy
Exception: allowed if >4 weeks before screening
Systemic anti-cancer therapy (e.g., chemotherapy, immunotherapy, monoclonal antibodies) within four weeks before screening visit
Lab requirements
Blood counts
Hemoglobin ≥9.0 g/dL; Platelet count ≥90 × 10⁹/L; White blood cell count ≥2.0 × 10⁹/L; absolute neutrophil count (ANC) >1.5 × 10⁹/L; must be met without recent transfusions (within 28 days prior to first study treatment) or growth factor support (within 21 days)
Kidney function
Serum/plasma creatinine ≤1.5 × upper limit of normal (ULN); exclusion if estimated glomerular filtration rate <60 mL/min
Hemoglobin ≥9.0 g/dL. Platelet count ≥90 × 10⁹/L. White blood cell count ≥2.0 × 10⁹/L, absolute neutrophil count (ANC) >1.5 × 10⁹/L. Serum/plasma creatinine ≤1.5 × upper limit of normal (ULN). Renal impairment (estimated glomerular filtration rate <60 mL/min), hemoglobin <9 g/dL, ANC <1.5 × 10⁹/L, or platelets < 90 × 10⁹/L [excluded].
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Excel Diagnostics & Nuclear Oncology Center · Houston, Texas
Showing up to 5 US sites. See all sites on ClinicalTrials.gov →
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