Clinical trial NCT02229565: Molecular Mechanisms Underlying Prostate Cancer Disparities
Official title: Molecular Mechanisms Underlying Prostate Cancer Disparities.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Prostate Cancer
Keywords: prostate cancer
prostate biopsy
prostatectomy
Lead sponsor: Duke University
Sponsor class: OTHER
First posted: 2014-09-01
Enrollment: 226
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

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.

Eligibility 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.

Primary outcomes:
measure: Proportion of high and low expression of identified gene targets in Caucasian and African American specimens
timeFrame: up to 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
Study officials:
affiliation: Duke University
name: Steven Patierno, PhD
role: PRINCIPAL_INVESTIGATOR
References: