Targeted Biopsies in Determining Response in Patients Wit... | NCT02597894

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

NCT02597894

Sponsor

Jonsson Comprehensive Cancer Center

Status

Withdrawn

Last Update Posted

Jul 24, 2020Actual

Enrollment

0Actual

Phase

Not Applicable

Conditions

Stage III Prostate Adenocarcinoma

Interventions

Biopsy of Prostate
Laboratory Biomarker Analysis

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description
NCI-2015-01737	Registry Identifier	CTRP (Clinical Trial Reporting Program)
JCCCID562	Other Identifier	Jonsson Comprehensive Cancer Center
15-000360	Other Identifier	UCLA / Jonsson Comprehensive Cancer Center

Status Module

Record Verification Date

Apr 2017

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

P. I. left the Institution. Study never opened

Expanded Access Info

Start Date

Mar 1, 2018Estimated

Primary Completion Date

Mar 1, 2019Estimated

Completion Date

Mar 1, 2020Estimated

First Submitted Date

Nov 2, 2015

First Submission Date that Met QC Criteria

Nov 3, 2015

First Posted Date

Nov 5, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 22, 2020

Last Update Posted Date

Jul 24, 2020Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Biopsy of Prostate	Procedure	Undergo biopsy	Prostate biopsy	Prostate Biopsy

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Mitchell Kamrava	UCLA / Jonsson Comprehensive Cancer Center	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
UCLA / Jonsson Comprehensive Cancer Center		Los Angeles	California	90095	United States