Molecular Mechanisms Underlying Prostate Cancer Disparities (GENCADE)

Duke University

Status: Completed

Conditions: Prostate Cancer

Treatments: Device: Biopsy or prostatectomy

Study type: Observational

Funder types: Other

Identifiers

NCT02229565

Pro00053535

Details and patient eligibility

About

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.

Full 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.

Enrollment: 226 patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

226 participants in 2 patient groups

Caucasian

Description:

Caucasian subjects having a biopsy or prostatectomy.

Treatment:

Device: Biopsy or prostatectomy

African American

Description:

African American subjects having a biopsy or prostatectomy.

Treatment:

Device: Biopsy or prostatectomy