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

NCT ID: NCT02597894

Last Updated: 2020-07-24

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-03-01
• Study Completion Date: 2020-03-01

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.

Conditions

Stage III Prostate Adenocarcinoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Prostate biopsy

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

Group Type: OTHER

Biopsy of Prostate

Intervention Type: PROCEDURE

Undergo biopsy

Laboratory Biomarker Analysis

Intervention Type: OTHER

Correlative studies

Interventions

Biopsy of Prostate

Undergo biopsy

Intervention Type: PROCEDURE

Laboratory Biomarker Analysis

Correlative studies

Intervention Type: OTHER

Other Intervention Names

Prostate Biopsy; Prostatic Biopsy

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Jonsson Comprehensive Cancer Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Mitchell Kamrava

Role: PRINCIPAL_INVESTIGATOR

UCLA / Jonsson Comprehensive Cancer Center

Locations

UCLA / Jonsson Comprehensive Cancer Center

Los Angeles, California, United States

Countries

United States

Other Identifiers

NCI-2015-01737

Identifier Type: REGISTRY

Identifier Source: secondary_id

JCCCID562

Identifier Type: OTHER

Identifier Source: secondary_id

15-000360

Identifier Type: OTHER

Identifier Source: secondary_id

15-000360

Identifier Type: -

Identifier Source: org_study_id