OncoMatch/Clinical Trials/NCT06972628
Treatment of Patients With Progressive mCRPC With 177Lu-PSMA-617
Is NCT06972628 recruiting? Yes, currently enrolling (Jun 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
Treatments studied
Radioligand therapy
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)
Demographics
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 →Frequently asked questions
Is NCT06972628 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior radiopharmaceutical, PSMA-targeted radioligand therapy, systemic anti-cancer therapy disqualifies patients from enrollment.
Does this trial require FOLH1?
Yes, FOLH1 PSMA-positive lesion on PET/CT is a required biomarker for enrollment.
Does this trial require AR?
Yes, AR castrate-level testosterone 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 qualifyRelated pages