Ignite Creation Date:
2025-12-25 @ 1:45 AM
Ignite Modification Date:
2026-03-03 @ 8:12 AM
Study NCT ID:
NCT02597894
Status:
WITHDRAWN
Last Update Posted:
2020-07-24
First Post:
2015-11-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Targeted Biopsies in Determining Response in Patients With Prostate Cancer Undergoing High-Dose-Rate Brachytherapy
Sponsor:
Jonsson Comprehensive Cancer Center
Organization:
Study Overview
Official Title:
Feasibility of Repeat Targeted Biopsies in Patients Undergoing High-Dose-Rate Prostate Brachytherapy
Status:
WITHDRAWN
Status Verified Date:
2017-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
P. I. left the Institution. Study never opened
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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 Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: