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Molecular Mechanisms Underlying Prostate Cancer Disparities

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ClinicalTrials.gov Identifier: NCT02229565
Recruitment Status : Recruiting
First Posted : September 1, 2014
Last Update Posted : February 19, 2019
Sponsor:
Information provided by (Responsible Party):
Duke University

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.

Condition or disease Intervention/treatment Phase
Prostate Cancer Device: Biopsy or prostatectomy Not Applicable

Detailed Description:
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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 198 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Molecular Mechanisms Underlying Prostate Cancer Disparities.
Actual Study Start Date : November 2014
Estimated Primary Completion Date : January 30, 2020
Estimated Study Completion Date : January 30, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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



Primary Outcome Measures :
  1. Proportion of high and low expression of identified gene targets in Caucasian and African American specimens [ Time Frame: up to 2 years ]
    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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02229565


Contacts
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Contact: Monika Anand 919.681.8838 monika.anand@duke.edu

Locations
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United States, North Carolina
Duke University Medical Center Recruiting
Durham, North Carolina, United States, 27710
Contact: Monika Anand    919-681-8838    monika.anand@duke.edu   
Principal Investigator: Steven Patierno, PhD         
Sponsors and Collaborators
Duke University
Investigators
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Principal Investigator: Steven Patierno, PhD Duke University

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Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT02229565     History of Changes
Other Study ID Numbers: Pro00053535
First Posted: September 1, 2014    Key Record Dates
Last Update Posted: February 19, 2019
Last Verified: February 2019
Keywords provided by Duke University:
prostate cancer
prostate biopsy
prostatectomy
Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases