Treatment of Patients With Progressive mCRPC With 177Lu-PSMA-617
Eligible age
18+ yrs
Accepts
Men
Locations
1 state
Healthy volunteers
No
See if you qualify for this study
Answer a few quick questions about your location and health. Takes about a minute.
About this study
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.
Sponsor: Ebrahim S Delpassand
You may qualify if…
- ✓ 1. Ability to understand and sign an informed consent form (ICF).
- ✓ 2. Willingness and ability to comply with study requirements.
- ✓ 3. Age ≥18 years.
- ✓ 4. Presence of skeletal metastases with a superscan pattern on a 99mTc-MDP/HDP bone scan, defined by significantly increased skeletal radioisotope uptake relative to soft tissues and faint or absent renal activity.
- ✓ 5. Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2.
- ✓ 6. Hemoglobin ≥9.0 g/dL.
- ✓ 7. Platelet count ≥90 × 10⁹/L.
- ✓ 8. White blood cell count ≥2.0 × 10⁹/L, absolute neutrophil count (ANC) \>1.5 × 10⁹/L.
You may not qualify if…
- ✕ 1. 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.
- ✕ 2. Prior PSMA-targeted radioligand therapy.
- ✕ 3. Systemic anti-cancer therapy (e.g., chemotherapy, immunotherapy, monoclonal antibodies) within four weeks before screening visit.
- ✕ 4. Known hypersensitivity to PLUVICTO or its components.
- ✕ 5. Concurrent treatment with other cytotoxic chemotherapy, immunotherapy, radioligand therapy, or investigational therapy.
- ✕ 6. Renal impairment (estimated glomerular filtration rate \<60 mL/min), hemoglobin \<9 g/dL, ANC \<1.5 × 10⁹/L, or platelets \< 90 × 10⁹/L.
- ✕ 7. History of CNS metastases unless treated and stable for 6 months, with no ongoing corticosteroid use.
- ✕ 8. Symptomatic or impending spinal cord compression.
Where it's recruiting
Houston
Source: ClinicalTrials.gov · NCT06972628 · last updated 2025-05-15