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

Clinicaltrials.gov ID: NCT05398302
db-list-check Status RECRUITING
b-loader Phase PHASE1
b-people Age All Ages
b-bullseye-arrow Enrollments 30

Conditions

Castration-Resistant Prostate Carcinoma, Metastatic Prostate Carcinoma, Stage IV Prostate Cancer American Joint Committee on Cancer (AJCC) v8, Stage IVA Prostate Cancer AJCC v8, Stage IVB Prostate Cancer AJCC v8

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.

Locations

1 location Found with status Recruiting

Status

  • RECRUITING

Contact Person

Principal Investigator

  • Johannes Czernin

Eligibility Criteria

Inclusion Criteria:

* Volunteer patient
* Histologically confirmed prostate cancer
* Eligible for 177Lu-PSMA-617 under expanded access protocol (IRB# 21-5010) or as part of an approved trial
* Based on positron emission tomography (PET)/computed tomography (CT) images: Evidence of lymph node or soft tissue metastatic disease amenable to image-guided biopsy
* Platelets > 75,000/ul within 14 days prior to biopsy
* Prothrombin time (PT) or International normalized ratio (INR) and a partial thromboplastin time (PTT) < 1.5 times the institutional upper limit normal (ULN) within 14 days prior to biopsy
* Patients on warfarin, aspirin, or other anti-coagulants are eligible provided they are deemed able to tolerate discontinuation of anti-coagulation for one week prior to the biopsy. Conversion to low molecular weight heparin prior to biopsy is permitted per local standard operating procedures, provided there is agreement regarding the procedure between the treating physician, the interventional radiologist and the principal investigator (PI)

Exclusion Criteria:

* Patients with significant congenital or acquired bleeding disorders (e.g. von Wildebrand's disease, acquired bleeding factor inhibitors) are not eligible

Study Plan

Diagnostic (image-guided biopsy)

EXPERIMENTAL

Patients undergo an image-guided biopsy at baseline and 2-4 weeks after cycle 2 of 177Lu-PSMA-617 therapy.

  • PROCEDURE:

    Image Guided Biopsy

    Description:

    Undergo image-guided biopsy

Outcome Measures

Primary Outcome Measures

Proportion of patients with a successful evaluable biopsy with molecular and cellular alterations after radioligand therapy (RLT)

Time Frame: At the end of cycle 2 before the initiation of cycle 3 of RLT (cycle is six weeks)

Secondary Outcome Measures

Proportion of patients with gene mutations that might confer resistance to RLT

Time Frame: At the end of cycle 2 before the initiation of cycle 3 of RLT (cycle is six weeks)

Timeline

  • Last Updated
    April 30, 2024
  • Start Date
    May 31, 2022
  • Today
    January 16, 2025
  • Completion Date ( Estimated )
    December 31, 2026

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