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

NCT02597894 | Withdrawn DMC

• 3 other identifiers: 15-000360NCI-2015-01737JCCCID562
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Stage III Prostate Adenocarcinoma

Outcome Measures

Primary Outcomes (1)

• 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.

  Two months

Study Arms (1)

Prostate biopsy

OTHER

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

Procedure: Biopsy of Prostate; Other: Laboratory Biomarker Analysis

Interventions

Biopsy of Prostate PROCEDURE

Undergo biopsy

Also known as: Prostate Biopsy, Prostatic Biopsy

Prostate biopsy

Laboratory Biomarker Analysis OTHER

Correlative studies

Prostate biopsy

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Jonsson Comprehensive Cancer Center: lead

Study Sites (1)

UCLA / Jonsson Comprehensive Cancer Center

Los Angeles, California, 90095, United States

Location

Study Officials

• Mitchell Kamrava

  UCLA / Jonsson Comprehensive Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 2, 2015
• First Posted: November 5, 2015
• Study Start: March 1, 2018
• Primary Completion: March 1, 2019
• Study Completion: March 1, 2020
• Last Updated: July 24, 2020

Record last verified: 2017-04

Locations

US (1)