Clinical Trials Directory

Trials / Recruiting

RecruitingNCT05398302

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

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

Status
Recruiting
Phase
Phase 1
Study type
Interventional
Enrollment
30 (estimated)
Sponsor
Jonsson Comprehensive Cancer Center · Academic / Other
Sex
Male
Age
—
Healthy volunteers
Not accepted

Summary

This clinical trial studies mechanisms of resistance to 177-lutetium prostate specific membrane antigen (177Lu-PSMA) radioligand therapy using image-guided biopsies in patients with castrate-resistant prostate cancer that had spread to other places in the body (metastatic). Diagnostic procedures, such as image guided biopsies, may help in learning how well 177Lu-PSMA works to kill tumor cells and allow doctors to plan better treatment.

Detailed description

PRIMARY OBJECTIVE: I. Proportion of metastatic castration resistant prostate cancer (mCRPC) patients with molecular and cellular alterations in tumor, immune and stromal cells after radioligand therapy assessed by histopathology/immunohistochemistry, ribonucleic acid (RNA)-sequencing and proteomic/phospho-proteomic analyses of biopsy samples. SECONDARY OBJECTIVE: I. Sequencing to identify frequently mutated genes. OUTLINE: Patients undergo an image-guided biopsy at baseline and 2-4 weeks after cycle 2 of 177Lu-PSMA-617 therapy.

Conditions

Interventions

TypeNameDescription
PROCEDUREImage Guided BiopsyUndergo image-guided biopsy

Timeline

Start date
2024-04-26
Primary completion
2026-12-31
Completion
2027-12-31
First posted
2022-05-31
Last updated
2026-03-30

Locations

1 site across 1 country: United States

Regulatory

Source: ClinicalTrials.gov record NCT05398302. Inclusion in this directory is not an endorsement.