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Prostate Cancer Prospective Cohort

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2014 by Washington University School of Medicine
Sponsor:
Collaborators:
Johns Hopkins University
Wake Forest School of Medicine
Information provided by (Responsible Party):
Washington University School of Medicine
ClinicalTrials.gov Identifier:
NCT00937586
First received: July 10, 2009
Last updated: August 4, 2014
Last verified: August 2014
  Purpose

The overall purpose of this research is to determine if certain genes increase the chance of developing prostate cancer and once diagnosed increase the chance of the prostate cancer spreading to other parts of the body.


Condition
Prostate Cancer

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Prostate Cancer Prospective Cohort

Resource links provided by NLM:


Further study details as provided by Washington University School of Medicine:

Primary Outcome Measures:
  • Ability to recognize increased risk of metastatic prostate cancer based on specific genetic polymorphisms. [ Time Frame: At the time of prostate cancer diagnosis ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Ability to predict risk for treatment failure based on analysis of specific polymorphisms. [ Time Frame: At the time of prostate cancer diagnosis ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples Without DNA

Whole blood, serum, white cells, prostate tissue.


Estimated Enrollment: 4100
Study Start Date: May 2000
Estimated Study Completion Date: June 2017
Estimated Primary Completion Date: June 2017 (Final data collection date for primary outcome measure)
Groups/Cohorts
Newly diagnosed patients
Patients with newly diagnosed prostate cancer.

Detailed Description:

DNA will be isolated from each person and then studied for the presence of certain genes that may increase the chance of developing prostate cancer. Certain genes will also be studied in patients with known prostate cancer to determine if they increase the chance of cancer spreading to other parts of the body and decrease one's chance of being cured. Small differences in genes can slightly affect their ability to function. While these differences are normal, they may influence the way the cancer responds to therapy. An understanding of which genes increase (or decrease) the chance of being cured of a disease, such as prostate cancer, will improve our ability to take care of patients more effectively.

A second purpose of this study is to collect blood and cancer tissue for future studies. While the small differences in genes may be the best marker of bad cancer, it is also possible that proteins in blood or tumor may be a better marker.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Patients with newly diagnosed prostate cancer are being recruited for this study from Siteman Cancer Center radiation oncology, medical oncology and urology clinics.

Criteria

Inclusion Criteria:

  • Newly diagnosed patients: 1. newly diagnosis of prostate cancer 2. untreated except for neoadjuvant systemic therapy.

Exclusion Criteria:

  • Newly diagnosed patients: 1. inability to give informed consent
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00937586

Contacts
Contact: Aleksandra P Klim, RN (314) 747-9781

Locations
United States, Missouri
Washington University School of Medicine Recruiting
St. Louis, Missouri, United States, 63110
Contact: Aleksandra P. Klim, RN    314-747-9781      
Sponsors and Collaborators
Washington University School of Medicine
Johns Hopkins University
Wake Forest School of Medicine
Investigators
Principal Investigator: Bettina Drake, PhD Washington University School of Medicine
  More Information

No publications provided

Responsible Party: Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT00937586     History of Changes
Other Study ID Numbers: HRPO#00-0327, R01CA112028
Study First Received: July 10, 2009
Last Updated: August 4, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Washington University School of Medicine:
Metastatic Prostate Cancer
Prostate Cancer Risk Assessment

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Diseases, Male
Genital Neoplasms, Male
Neoplasms
Neoplasms by Site
Prostatic Diseases
Urogenital Neoplasms

ClinicalTrials.gov processed this record on November 20, 2014