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

Sponsor
Jonsson Comprehensive Cancer Center (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05398302
Collaborator
(none)
30
Enrollment
1
Location
1
Arm
27
Anticipated Duration (Months)
1.1
Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Image Guided Biopsy
 Phase 1

Detailed Description

PRIMARY OBJECTIVE:
  1. 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:
  1. 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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
30 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Diagnostic
Official Title:
Radiologically Guided Biopsies of Metastatic Castration Resistant Prostate Cancer to Identify Mechanisms of Resistance in Patients Undergoing 177Lu-PSMA Radioligand Therapy
Anticipated Study Start Date :
Oct 1, 2022
Anticipated Primary Completion Date :
Dec 31, 2023
Anticipated Study Completion Date :
Dec 31, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: Diagnostic (image-guided biopsy)

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

Procedure: Image Guided Biopsy
Undergo image-guided biopsy
Other Names:
  • Image-Guided Biopsy
  • Imaging Guided Biopsy

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Proportion of patients with a successful evaluable biopsy with molecular and cellular alterations after radioligand therapy (RLT) [At the end of cycle 2 before the initiation of cycle 3 of RLT (cycle is six weeks)]

    Secondary Outcome Measures

    1. Proportion of patients with gene mutations that might confer resistance to RLT [At the end of cycle 2 before the initiation of cycle 3 of RLT (cycle is six weeks)]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    Male
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 UCLA / Jonsson Comprehensive Cancer Center Los Angeles California United States 90095

    Sponsors and Collaborators

    • Jonsson Comprehensive Cancer Center

    Investigators

    • Principal Investigator: Johannes Czernin, UCLA / Jonsson Comprehensive Cancer Center

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Jonsson Comprehensive Cancer Center
    ClinicalTrials.gov Identifier:
    NCT05398302
    Other Study ID Numbers:
    • 22-000460
    • NCI-2021-12416
    First Posted:
    May 31, 2022
    Last Update Posted:
    Jun 21, 2022
    Last Verified:
    May 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Product Manufactured in and Exported from the U.S.:
    No
    Additional relevant MeSH terms:
    Carcinoma
    Prostatic Neoplasms

    Study Results

    No Results Posted as of Jun 21, 2022