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Molecular Mechanisms Underlying Prostate Cancer Disparities

NCT ID: NCT02229565

Last Updated: 2020-11-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

226 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-11-30

Study Completion Date

2019-10-14

Brief Summary

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The purpose of this study is to further elucidate the molecular mechanisms underlying prostate cancer disparities. In previous work the investigators have identified a set of differentially deregulated genes in African American versus Caucasian American prostate cancer. Based on these findings, they hypothesize that they will be able to validate these targets, originally identified in the previous work conducted at The George Washington University Medical Center, in an independent Duke University Medical Center cohort of prostate cancer specimens. In addition, the investigators hypothesize that they will be able to discover novel targets in the Duke University Medical Center cohort of prostate cancer specimens because of regional differences.

Detailed Description

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Individual patient African American and Caucasian American prostate biopsy cores or surgical specimens will be obtained from the following procedures: transrectal ultrasound biopsy of the prostate (TRUSBxP), MR fusion biopsy, intra-operatively (IO) at the time of prostatectomy. Using cellular DNA and RNA, isolated from prostate cancer and patient-matched normal prostate biopsy cores or surgical specimens, the investigators will perform ancestral genotyping, exon arrays, targeted RNA sequencing, and epigenetic analyses. As controls, blood will also be collected. Genomic data from blood and tumor tissue will be compared.

Conditions

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Prostate Cancer

Keywords

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prostate cancer prostate biopsy prostatectomy

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Caucasian

Caucasian subjects having a biopsy or prostatectomy.

Biopsy or prostatectomy

Intervention Type DEVICE

African American

African American subjects having a biopsy or prostatectomy.

Biopsy or prostatectomy

Intervention Type DEVICE

Interventions

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Biopsy or prostatectomy

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Suspected malignancy of prostate cancer
* Self-reported race of African American or Caucasian American
* Age \>/= 18 years
* Able to read, understand and sign an informed consent document

Exclusion Criteria

* Collected tumor tissue is inadequate for DNA and RNA analysis and/or is not positive for adenocarcinoma of the prostate.
* Patients with prior systemic therapy will not be eligible for the study, i.e. radiation or chemo or immunotherapy.
Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Duke University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Steven Patierno, PhD

Role: PRINCIPAL_INVESTIGATOR

Duke University

Locations

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Duke University Medical Center

Durham, North Carolina, United States

Site Status

Countries

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United States

Other Identifiers

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Pro00053535

Identifier Type: -

Identifier Source: org_study_id