NCT02597894

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

Feasibility of Repeat Targeted Biopsies in Patients Undergoing High-Dose-Rate Prostate Brachytherapy

• Status: Withdrawn
• Phase: N/A
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Jonsson Comprehensive Cancer Center · Academic / Other
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
PROCEDURE	Biopsy of Prostate	Undergo biopsy
OTHER	Laboratory Biomarker Analysis	Correlative studies

Timeline

• Start date: 2018-03-01
• Primary completion: 2019-03-01
• Completion: 2020-03-01
• First posted: 2015-11-05
• Last updated: 2020-07-24

Locations

1 site across 1 country: United States