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DNA Changes in Patients With Prostate Cancer

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified January 2007 by National Cancer Institute (NCI).
Recruitment status was:  Not yet recruiting
National Cancer Institute (NCI)
Information provided by:
National Cancer Institute (NCI) Identifier:
First received: May 9, 2009
Last updated: February 18, 2011
Last verified: January 2007

RATIONALE: Collecting and storing samples of blood from patients and their brothers with cancer to study in the laboratory may help doctors learn more about changes that may occur in DNA and identify biomarkers related to cancer.

PURPOSE: This laboratory study is looking at changes in DNA in patients and their brothers with prostate cancer.

Condition Intervention
Prostate Cancer
Genetic: polymorphism analysis
Other: laboratory biomarker analysis

Study Type: Observational
Official Title: Assessment of SNP Genotypes in Men With Prostate Cancer

Resource links provided by NLM:

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Frequency of single nucleotide polymorphism (SNP) genotypes
  • Age of onset of prostate cancer in patients and their affected siblings
  • Likelihood that given SNPs result in disease as assessed by Mendelian genetics
  • Odds ratio of developing prostate cancer in the presence of SNPs
  • Correlation of SNP genotypes of patients enrolled in ECOG-E3805 with disease progression

Estimated Enrollment: 646
Study Start Date: July 2006
Detailed Description:


  • Determine the frequency of single nucleotide polymorphism (SNP) genotypes in patients with prostate cancer, their affected siblings, and an unaffected healthy population (control).
  • Determine the age of onset of prostate cancer in affected probands and affected siblings.
  • Determine the penetrance or likelihood that given SNPs will result in disease in affected siblings based upon Mendelian genetics.
  • Determine the odds ratio of developing prostate cancer in the presence of SNPs.
  • Determine SNP genotypes in patients enrolled on ECOG-E3805, a prostate phase III study enrolling men with D2 prostate cancer treated with androgen-ablation therapy alone or androgen-ablation therapy with chemotherapy, and correlate them with disease progression (i.e., androgen independence).

OUTLINE: This is an open-label, multicenter study. Patients are stratified according to ethnicity, age at diagnosis, and Gleason score.

Patients, their affected siblings, and healthy participants (controls) undergo collection of blood samples. Genomic DNA is extracted from whole blood and sequenced for single nucleotide polymorphisms (SNPs) in Akt and mdm-2 genes. SNP data is correlated with clinical and biographical data.

PROJECTED ACCRUAL: A total of 500 patients (250 probands and 250 siblings) and 146 healthy participants (controls) will be accrued for this study.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes


  • Meets one of the following criteria:

    • Patient or sibling diagnosed with prostate cancer
    • Cancer-free participant (healthy control)
  • Whole blood sample available


  • Not specified


  • Not specified
  Contacts and Locations
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Please refer to this study by its identifier: NCT00899184

Sponsors and Collaborators
Eastern Cooperative Oncology Group
National Cancer Institute (NCI)
Study Chair: Kim M. Hirshfield, MD, PhD Rutgers Cancer Institute of New Jersey
  More Information Identifier: NCT00899184     History of Changes
Other Study ID Numbers: CDR0000492784
Study First Received: May 9, 2009
Last Updated: February 18, 2011

Keywords provided by National Cancer Institute (NCI):
recurrent prostate cancer
stage IV prostate cancer
stage I prostate cancer
stage IIB prostate cancer
stage IIA prostate cancer
stage III prostate cancer

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Genital Diseases, Male
Prostatic Diseases processed this record on April 28, 2017