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Targeted Biopsies in Determining Response in Patients With Prostate Cancer Undergoing High-Dose-Rate Brachytherapy

Sponsor
Jonsson Comprehensive Cancer Center (Other)
Overall Status
Withdrawn
CT.gov ID
NCT02597894
Collaborator
(none)
0
Enrollment
1
Location
1
Arm
24
Anticipated Duration (Months)
0
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This pilot clinical trial studies targeted biopsies in determining response in patients with prostate cancer undergoing high-dose-rate brachytherapy (a type of radiation therapy in which radioactive material sealed in needles, seeds, wires, or catheters is placed directly into or near a tumor). Studying tumor tissue obtained before and after treatment may help doctors understand changes in a pathway that looks at how deoxyribonucleic acid (DNA) is repaired after it is damaged and to see if there are differences in the prostate tissue prior to and after starting androgen deprivation therapy.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Biopsy of Prostate
  • Other: Laboratory Biomarker Analysis
 N/A

Detailed Description

PRIMARY OBJECTIVES:
  1. Demonstrate feasibility of obtaining adequate tumor tissue from an intra-prostatic index lesion prior to the start of androgen deprivation therapy (ADT) and again at the time of high-dose-rate (HDR) brachytherapy.
SECONDARY OBJECTIVES:
  1. Use immunohistochemistry to stain cells pre-ADT and post 2 months of ADT for markers of non-homologous end joining and DNA double strand breaks using the following markers: Ku70, Ku80, DNA-dependent protein kinase catalytic subunits (PKCs), gamma-histone family, member X (H2AX).
OUTLINE:

Patients undergo biopsy at baseline before start of ADT and during brachytherapy.

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:
Feasibility of Repeat Targeted Biopsies in Patients Undergoing High-Dose-Rate Prostate Brachytherapy
Anticipated Study Start Date :
Mar 1, 2018
Anticipated Primary Completion Date :
Mar 1, 2019
Anticipated Study Completion Date :
Mar 1, 2020

Arms and Interventions

Arm Intervention/Treatment
Other: Prostate biopsy

Patients undergo two biopsies, the first at baseline before start of ADT and the second two months later during brachytherapy.

Procedure: Biopsy of Prostate
Undergo biopsy
Other Names:
  • Prostate Biopsy
  • Prostatic Biopsy

    • Other: Laboratory Biomarker Analysis
    Correlative studies

    Outcome Measures

    Primary Outcome Measures

    1. Changes in DNA damage repair pathways [Two months]

      The prostate biopsy sample at baseline and at the time of brachytherapy (approximately two months later) will be examined to determine if prostate cancer is in the core and if at least 20% of the core has prostate cancer in it.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    Male
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Histologically confirmed primary adenocarcinoma of the prostate

    • National Comprehensive Cancer Network (NCCN) high risk disease (cT3 or Gleason score 8-10 or prostate specific antigen [PSA] > 20)

    • Not currently on ADT

    • Magnetic resonance imaging (MRI) or transrectal doppler ultrasound demonstrating at least one target lesion

    • Karnofsky performance status (KPS) >= 70 or Eastern Cooperative Oncology Group (ECOG) = 2

    • Understands the trial and procedure and is willing and able to sign the informed consent form

    Exclusion Criteria:

    • Patient is unable to receive high dose rate prostate brachytherapy

    • Patient is unable to have a MRI or transrectal ultrasound

    • Refusal to sign the informed consent

    • Patients who are participating in a concurrent treatment protocol

    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: Mitchell Kamrava, 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:
    NCT02597894
    Other Study ID Numbers:
    • 15-000360
    • NCI-2015-01737
    • JCCCID562
    • 15-000360
    First Posted:
    Nov 5, 2015
    Last Update Posted:
    Jul 24, 2020
    Last Verified:
    Apr 1, 2017
    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:
    Adenocarcinoma

    Study Results

    No Results Posted as of Jul 24, 2020