Study of Image-Guided Biopsies to Find Resistance Causes in Men With Metastatic Castration-Resistant Prostate Cancer Treated With 177Lu-PSMA Radioligand Therapy

What this Trial Is About

Researchers are investigating how metastatic castration-resistant prostate cancer mCRPC may develop resistance to 177Lu-PSMA radioligand therapy. This study focuses on patients whose cancer has spread to other parts of the body and aims to better understand tumor cell response and resistance mechanisms through image-guided biopsies. The research is conducted as a Phase 1 trial to identify molecular and cellular changes after therapy. Participants receive 177Lu-PSMA-617 radioligand therapy, with image-guided biopsies performed at baseline and again 2 to 4 weeks after the second cycle of treatment. Each cycle lasts six weeks, and biopsies help analyze tumor, immune, and stromal cells using advanced techniques like histopathology, immunohistochemistry, RNA sequencing, and proteomic analyses to detect changes and gene mutations related to resistance. During the study, participants undergo diagnostic image-guided biopsies and clinical assessments before and after treatment cycles. Researchers measure the proportion of patients with successful biopsies showing molecular and cellular alterations, as well as identifying gene mutations that may confer resistance to treatment. The study helps inform future treatment planning and monitoring for men with advanced prostate cancer.

Image-Guided Biopsies to Identify Mechanisms of Resistance in Patients With Metastatic Castration Resistant Prostate Cancer Treated With 177Lu-PSMA Radioligand Therapy