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

Not Applicable

Withdrawn

• Conditions: Stage III Prostate Adenocarcinoma
• Interventions: Procedure: Biopsy of Prostate; Other: Laboratory Biomarker Analysis

• Registration Number: NCT02597894
• Lead Sponsor: Jonsson Comprehensive Cancer Center

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.

Study Timeline

• Study First Submitted: 2015-11-02
• Study First Submitted QC: 2015-11-03
• Study First Posted: 2015-11-05
• Status Verified: 2017-04
• Study Start: 2018-03-01
• Primary Completion: 2019-03-01
• Study Completion: 2020-03-01
• Last Update Submitted: 2020-07-22
• Last Update Posted: 2020-07-24

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: Male
• Target Recruitment: Not specified

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Prostate biopsy	Laboratory Biomarker Analysis	Patients undergo two biopsies, the first at baseline before start of ADT and the second two months later during brachytherapy.
Prostate biopsy	Biopsy of Prostate	Patients undergo two biopsies, the first at baseline before start of ADT and the second two months later during brachytherapy.

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

UCLA / Jonsson Comprehensive Cancer Center; 🇺🇸 Los Angeles, California, United States