Study of Pluvicto for Metastatic Prostate Cancer with Extensive Bone Metastasis
This study is testing Lutetium-177-PSMA-617 (PLUVICTO) in men with metastatic castration-resistant prostate cancer (mCRPC), a type of prostate cancer that has spread and no longer responds to hormone therapy. Specifically, it's for those whose bone scans show a "superscan" pattern, meaning widespread cancer in the bones. While Pluvicto is FDA-approved, this group of patients was not included in previous studies, so we need to learn more about how it works for them. The study aims to find the safest and most effective dose of Pluvicto for up to 30 participants. Success will be measured by how long patients live without their cancer getting worse (radiographic progression-free survival) and overall survival. The study status is currently unclear.
- Study design
- This is an interventional study that will enroll up to 30 men. It uses a modified dose-escalation approach, starting with a lower dose and gradually increasing it.
- What's involved
- Participants will receive six doses of Pluvicto, given approximately every six weeks. Routine lab tests and monitoring for side effects will be conducted throughout the study.
- Compensation
- Not stated in the trial record.
- Follow-up
- Participants will be followed from enrollment until their cancer progresses or they pass away, for up to 24 months.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Treatment of Patients With Progressive mCRPC With 177Lu-PSMA-617
At a glance
Conditions
Where it's being run
1 sites across 1 statesStudy leadership
- Ebrahim S. Delpassand, M.D. Chairman & Medical Director, MD., Nuclear Medicine · PRINCIPAL_INVESTIGATOR · Excel Diagnostics & Nuclear Oncology Center
Who to contact
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What this trial measures
- Radiographic progression-free survivalFrom date of enrollment until the date of first documented radiographic disease progression or date of death from any cause, whichever came first, assessed up to 24 months.
rPFS: Defined as the time from enrollment to radiographic disease progression, based on Prostate Cancer Working Group 3 (PCWG3) Guidelines (Scher et al., 2016), or death from any cause.
- Overall SurvivalFrom date of enrollment until the date of death from any cause, assessed up to 24 months.
OS: Defined as the time from enrollment to death from any cause.