Lutetium-177-PSMA-617 for Prostate Cancer

Overseen By Susan Cork Therapy Coordinator

Age: 18+

Sex: Male

Trial Phase: Phase 2

Sponsor: Ebrahim S Delpassand

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Breakthrough Therapy This drug has been fast-tracked for approval by the FDA given its high promise

Compensation: Varies

Number of Visits: Unknown

30 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Research Team

Ebrahim S. Delpassand, M.D. Chairman & Medical Director, MD., Nuclear Medicine

Principal Investigator

Excel Diagnostics & Nuclear Oncology Center

Eligibility Criteria

Men over 18 with metastatic castration-resistant prostate cancer (mCRPC) and extensive bone metastases visible on a bone scan. They must have good performance status, adequate blood counts, normal kidney function, confirmed prostate cancer with PSMA-positive lesions, low testosterone levels due to treatment, and previous ARAT therapy. Excluded are those who've had recent radiopharmaceuticals or systemic anti-cancer therapies, hypersensitivity to PLUVICTO components, other ongoing treatments or malignancies affecting life expectancy.

Inclusion Criteria

Ability to understand and sign an informed consent form (ICF)

Hemoglobin ≥9.0 g/dL

Platelet count ≥90 × 10⁹/L

Exclusion Criteria

Plans to conceive or father a child during treatment and up to six months post-treatment

I haven't had cancer treatment in the last 4 weeks.

My kidney function is low, or I have low blood counts.

Treatment Details

Interventions

• Lutetium-177-PSMA-617 (PLUVICTO)

Trial Overview The trial is testing the safety and optimal dosing of Lutetium-177-PSMA-617 (PLUVICTO) in up to 30 men with mCRPC showing a 'super scan' pattern of bone metastases. This study fills a knowledge gap left by prior trials that excluded such patients. Participants will receive an initial dose different from the standard as researchers seek the best dosage for this specific condition.

Participant Groups

Group I: Treatment Arm Experimental Treatment 1 Intervention

Who Is Running the Clinical Trial?

Ebrahim S Delpassand

Lead Sponsor

Trials

1

Recruited

140+