Targeted Biopsies in Determining Response in Patients With Prostate Cancer Undergoing High-Dose-Rate Brachytherapy
July 22, 2020 updated by: Jonsson Comprehensive Cancer Center
Feasibility of Repeat Targeted Biopsies in Patients Undergoing High-Dose-Rate Prostate Brachytherapy
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.
Study Overview
Status
Withdrawn
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
California
-
Los Angeles, California, United States, 90095
- UCLA / Jonsson Comprehensive Cancer Center
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Male
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / 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.
|
Correlative studies
Undergo biopsy
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Changes in DNA damage repair pathways
Time Frame: 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.
|
Two months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Mitchell Kamrava, UCLA / Jonsson Comprehensive Cancer Center
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Anticipated)
March 1, 2018
Primary Completion (Anticipated)
March 1, 2019
Study Completion (Anticipated)
March 1, 2020
Study Registration Dates
First Submitted
November 2, 2015
First Submitted That Met QC Criteria
November 3, 2015
First Posted (Estimate)
November 5, 2015
Study Record Updates
Last Update Posted (Actual)
July 24, 2020
Last Update Submitted That Met QC Criteria
July 22, 2020
Last Verified
April 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 15-000360 (Other Identifier: UCLA / Jonsson Comprehensive Cancer Center)
- NCI-2015-01737 (Registry Identifier: CTRP (Clinical Trial Reporting Program))
- JCCCID562 (Other Identifier: Jonsson Comprehensive Cancer Center)
Drug and device information, study documents
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
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.