RecruitingPhase 2NCT06798558

Neoadjuvant Lu-177-PSMA-617 in Patients With High Risk Localized Prostate Cancer Undergoing Radical Prostatectomy

Phase II Study of Neoadjuvant Lu-177-PSMA-617 in Patients With High Risk Localized Prostate Cancer Undergoing Radical Prostatectomy


Sponsor

Hackensack Meridian Health

Enrollment

54 participants

Start Date

Mar 5, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

Male adults with a confirmed diagnosis of prostate adenocarcinoma who meet criteria for localized high risk prostate cancer according to the NCCN guidelines and who are eligible for prostatectomy will be invited to participate. Criteria for high-risk prostate cancer include patients with preoperative prostate biopsy score of Gleason 8 (GS8) (Grade group 4 \[GG4\]) or higher. Patients also need to have a positive PSMA scan on 68-Ga-PSMA-11 PET/CT scan.


Eligibility

Sex: MALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests a radioactive drug called Lu-177-PSMA-617 — given before surgery — in men with high-risk localized prostate cancer. PSMA is a protein found on prostate cancer cells, and this drug delivers targeted radiation directly to those cells. The hope is that treating the cancer before surgery will improve outcomes after the prostate is removed. **You may be eligible if...** - You are 18 or older - You have prostate cancer confirmed by biopsy, with a Gleason score of 8 or higher (a measure of how aggressive the cancer is) - A special PSMA PET/CT scan shows strong PSMA expression in your prostate - You have a life expectancy of more than 10 years - You are willing and able to undergo surgery **You may NOT be eligible if...** - Your PSMA scan does not show adequate expression on the prostate - You have cancer spread to distant sites beyond the pelvis on PET imaging - You have conditions making surgery or the radioactive drug unsafe Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DRUGLu-17-PSMA-617

Lu-17-PSMA-617 administration


Locations(3)

MedStar Washington Hospital Center

Washington D.C., District of Columbia, United States

Lombardi Comprehensive Cancer Center at Georgetown University Medical Center

Washington D.C., District of Columbia, United States

John Theurer Cancer Center at Hackensack University Medical Center

Hackensack, New Jersey, United States

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT06798558


Related Trials