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.
Ability to understand and sign an informed consent form (ICF).
Willingness and ability to comply with study requirements.
Age ≥18 years.
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.
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.
Prior PSMA-targeted radioligand therapy.
Systemic anti-cancer therapy (e.g., chemotherapy, immunotherapy, monoclonal antibodies) within four weeks before screening visit.
Known hypersensitivity to PLUVICTO or its components.
Ebrahim S Delpassand
Lead sponsor
Excel Diagnostics and Nuclear Oncology Center
Sponsor institution