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

Primary Purpose

Stage III Prostate Adenocarcinoma

Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Biopsy of Prostate
Laboratory Biomarker Analysis
Sponsored by
Jonsson Comprehensive Cancer Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Stage III Prostate Adenocarcinoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

  • UCLA / Jonsson Comprehensive Cancer Center

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Prostate biopsy

Arm Description

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

Outcomes

Primary Outcome Measures

Changes in DNA damage repair pathways
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.

Secondary Outcome Measures

Full Information

First Posted
November 2, 2015
Last Updated
July 22, 2020
Sponsor
Jonsson Comprehensive Cancer Center
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1. Study Identification

Unique Protocol Identification Number
NCT02597894
Brief Title
Targeted Biopsies in Determining Response in Patients With Prostate Cancer Undergoing High-Dose-Rate Brachytherapy
Official Title
Feasibility of Repeat Targeted Biopsies in Patients Undergoing High-Dose-Rate Prostate Brachytherapy
Study Type
Interventional

2. Study Status

Record Verification Date
April 2017
Overall Recruitment Status
Withdrawn
Why Stopped
P. I. left the Institution. Study never opened
Study Start Date
March 1, 2018 (Anticipated)
Primary Completion Date
March 1, 2019 (Anticipated)
Study Completion Date
March 1, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Jonsson Comprehensive Cancer Center

4. Oversight

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
Data Monitoring Committee
Yes

5. 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.
Detailed Description
PRIMARY OBJECTIVES: I. 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: I. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stage III Prostate Adenocarcinoma

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Prostate biopsy
Arm Type
Other
Arm Description
Patients undergo two biopsies, the first at baseline before start of ADT and the second two months later during brachytherapy.
Intervention Type
Procedure
Intervention Name(s)
Biopsy of Prostate
Other Intervention Name(s)
Prostate Biopsy, Prostatic Biopsy
Intervention Description
Undergo biopsy
Intervention Type
Other
Intervention Name(s)
Laboratory Biomarker Analysis
Intervention Description
Correlative studies
Primary Outcome Measure Information:
Title
Changes in DNA damage repair pathways
Description
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.
Time Frame
Two months

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mitchell Kamrava
Organizational Affiliation
UCLA / Jonsson Comprehensive Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
UCLA / Jonsson Comprehensive Cancer Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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