Phase I Study to Evaluate Safety and Effectiveness of 177Lu Lu-PSMA-XT in Men With Metastatic Prostate Cancer

What this Trial Is About

Researchers are evaluating the safety, tolerability, radiation distribution, and effectiveness of 177Lu Lu-PSMA-XT injection in men with metastatic prostate cancer in this open-label, phase I trial. The study focuses on patients with metastatic castration-resistant prostate cancer who show PSMA-positive scans and have undergone prior therapies such as taxane-based chemotherapy or are unsuitable for it. This research aims to better understand how this radioligand therapy works in targeting PSMA-expressing cancer cells. The treatment being studied is 177LuLu-PSMA-XT, a radioligand therapy that delivers beta-particle radiation directly to prostate-specific membrane antigen PSMA expressing cells. Participants receive this therapy during the study to assess safety, radiation absorption by the body and organs, and the therapys impact on prostate cancer markers. The study tracks dose-limiting toxicity and adverse events through completion, with assessments lasting up to two years. Participants will be monitored for treatment-emergent adverse events, radiation dosimetry, and changes in prostate-specific antigen PSA levels. Researchers will also evaluate progression-free survival, response rates, duration of response, and skeletal event timing over the course of up to two years. The study includes regular imaging, blood tests, and clinical evaluations to assess the therapys effects and safety throughout the trial period.

A Study of [177Lu] Lu-PSMA-XT Injection in Patients With Metastatic Prostate Cancer