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Image-Guided Biopsies in Identifying Mechanisms of Resistance in Participants With Metastatic Castration Resistant Prostate Cancer Undergoing Radioligand Therapy

Sponsor
Jonsson Comprehensive Cancer Center (Other)
Overall Status
Withdrawn
CT.gov ID
NCT03596710
Collaborator
National Cancer Institute (NCI) (NIH)
0
Enrollment
1
Arm
48
Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

This trial studies image-guided biopsies work in identifying mechanisms of resistance in participants with castration resistant prostate cancer that has spread to other places in the body and who are undergoing radioligand therapy (RLT). Tissue sample collected from a biopsy may help determine why response to RLT varies among patients, and this may help researchers to find better treatments for advanced prostate cancer.

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

Detailed Description

PRIMARY OBJECTIVES:
  1. Proportion of metastatic castration resistant prostate cancer (mCRPC) patients with altered signaling pathways after radioligand therapy assessed by phospho-proteomics of biopsy samples.
SECONDARY OBJECTIVES:

  1. Generation of patient derived xenograft (PDX) models to determine if tumor levels of activity for individual adaptive pathways are related to the best prostate specific antigen (PSA) response.

  2. Sequencing to identify frequently mutated genes such as TP53 and ATM.

OUTLINE:

Participants undergo image-guided biopsy over 45 minutes prior to first RLT course and 1-2 days after the third RLT course.

Study Design

Study Type:
Interventional
Actual Enrollment :
0 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 Adaptive Mechanisms of Resistance in Patients Undergoing 177Lu-PSMA Radioligand Therapy
Actual Study Start Date :
Jun 14, 2018
Anticipated Primary Completion Date :
Jun 14, 2021
Anticipated Study Completion Date :
Jun 14, 2022

Arms and Interventions

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

Participants undergo image-guided biopsy over 45 minutes prior to first RLT course and 1-2 days after the third RLT course.

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 altered signaling pathways after radioligand therapy (RLT) [Up to 3 years]

      No statistical power analysis was performed as this is a pilot study. An unbiased proteomic/phospho-proteomics analysis will be done and it is unknown how many and which parameters will change in response to radioligand therapy. The study will in subsequent studies use the information obtained here to design a more definitive trial.

    Secondary Outcome Measures

    1. Proportion of patients with gene mutation in regulators of replication stress response according to sequencing [Up to 3 years]

      No statistical power analysis was performed as this is a pilot study. An unbiased proteomic/phospho-proteomics analysis will be done and it is unknown how many and which parameters will change in response to radioligand therapy. The study will in subsequent studies use the information obtained here to design a more definitive trial.

    2. Generation of xenografts [Up to 3 years]

      No statistical power analysis was performed as this is a pilot study. An unbiased proteomic/phospho-proteomics analysis will be done and it is unknown how many and which parameters will change in response to radioligand therapy. The study will in subsequent studies use the information obtained here to design a more definitive trial.

    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

    • Enrolled in Lu-PSMA-617 treatment trial (Institutional Review Board [IRB]# 17-000330)

    • 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 of 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

    No locations specified.

    Sponsors and Collaborators

    • Jonsson Comprehensive Cancer Center
    • National Cancer Institute (NCI)

    Investigators

    • Principal Investigator: Matthew Rettig, 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:
    NCT03596710
    Other Study ID Numbers:
    • 18-000273
    • NCI-2018-01422
    • 18-000273
    • P50CA092131
    First Posted:
    Jul 24, 2018
    Last Update Posted:
    Jul 23, 2020
    Last Verified:
    Jul 1, 2018
    Studies a U.S. FDA-regulated Drug Product:
    No
    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 Jul 23, 2020