Molecular Mechanisms Underlying Prostate Cancer Disparities

NCT02229565 | Completed

• 1 other identifier: Pro00053535
• Study Type: observational
• Target: 226
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Prostate Cancer

Keywords

prostate cancer; prostate biopsy; prostatectomy

Outcome Measures

Primary Outcomes (1)

• Proportion of high and low expression of identified gene targets in Caucasian and African American specimens

  Total RNA will be interrogated for mRNA expression patterns with the Affymetrix Human Exon 1.0 ST GeneChip. Microarray data will be normalized by quantile normalization with background correction. Targeted RNA sequencing of the previously identified genetic factors specific to African American prostate cancer will confirm altered expression and alternative splicing in these deregulated genes. The Agilent Technologies SureSelect RNA Custom Capture Kit will capture and sequence transcripts. Epigenetic analyses of the genetic factors specific to African American prostate cancer will identify DNA methylation and histone modification patterns in these deregulated genes. The Sequenom EpiTYPER will screen for differential methylation and methylation differences will be quantified using pyrosequencing. Differential histone modification patterns will be explored. Analysis will be performed on 33 prostate cancer biopsy specimens from each of 6 groups stratified by race and Gleason grade.

  up to 2 years

Study Arms (2)

Caucasian

Caucasian subjects having a biopsy or prostatectomy.

Device: Biopsy or prostatectomy

African American

African American subjects having a biopsy or prostatectomy.

Device: Biopsy or prostatectomy

Interventions

Biopsy or prostatectomy DEVICE

African American; Caucasian

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population includes African American and Caucasian American patients (self-reported) undergoing clinically indicated diagnostic biopsies for a suspected prostate malignancy or intra-operative biopsies of patients undergoing clinically indicated prostatectomy for a confirmed prostate cancer.

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Duke University: lead

Study Sites (1)

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Biopsy; Prostatectomy

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Cytodiagnosis; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Specimen Handling; Diagnostic Techniques, Surgical; Surgical Procedures, Operative; Investigative Techniques; Urologic Surgical Procedures, Male; Urologic Surgical Procedures; Urogenital Surgical Procedures

Study Officials

• Steven Patierno, PhD

  Duke University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 12, 2014
• First Posted: September 1, 2014
• Study Start: November 1, 2014
• Primary Completion: October 14, 2019
• Study Completion: October 14, 2019
• Last Updated: November 13, 2020

Record last verified: 2020-11

Locations

US (1)