NCT00342784

Brief Summary

This study will identify genes that predispose men to prostate cancer and affect the rate and type of disease spread, the aggressiveness of the disease, and the long-term outcome. Several studies show there is a genetic component to prostate cancer susceptibility, and that a first-degree relative with prostate cancer increases a man's risk 2- to 3-fold compared to those without a family history. The risk is significantly higher if the relative was diagnosed at younger than 65 years of age, or if three or more first-degree relatives are affected. The study will try to locate prostate cancer genes in DNA samples using two methods: linkage analysis and association studies. Traditionally, the search for a disease gene begins with linkage analysis, in which the aim is to find the rough location of the gene relative to another DNA sequence, called a "genetic marker," whose position is already known. In genetic association studies, genes from a large number of patients are compared with healthy controls who are matched by age, race, and geographic region. DNA samples for this study come from patients in the two following studies at the Fred Hutchinson Cancer Research Center, Seattle, Washington: Family study: Participants are families with prostate cancer who have: 1) three or more first-degree relatives with prostate cancer; 2) three generations with prostrate cancer either through the maternal or paternal side of the family; or 3) two first-degree relatives with prostate cancer diagnosed before age 65 or who were African American. Population-based study: Participants are patients with prostate cancer and matched healthy control subjects. The identification of prostate cancer genes important in susceptibility to the disease and its aggressiveness may permit earlier detection and development of more directed and effective treatments based on underlying genetics.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
5,118

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2004

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 8, 2004

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

June 19, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 21, 2006

Completed
12.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 30, 2018

Completed
Last Updated

August 1, 2018

Status Verified

July 30, 2018

First QC Date

June 19, 2006

Last Update Submit

July 31, 2018

Conditions

Keywords

MutationCancer Genetics

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Study families were required to meet at least one of the following criteria:
  • Have three or more first-degree relatives with PC
  • Have three generations with PC, either through paternal or maternal lineage; or
  • Have two-first degree relatives with PC diagnosed before age 65 or who were African American. All surviving men, and selected unaffected men and females were invited to join.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Human Genome Research Institute (NHGRI), 9000 Rockville Pike

Bethesda, Maryland, 20892, United States

Location

Related Publications (3)

  • Fincham SM, Hill GB, Hanson J, Wijayasinghe C. Epidemiology of prostatic cancer: a case-control study. Prostate. 1990;17(3):189-206. doi: 10.1002/pros.2990170303.

    PMID: 2235728BACKGROUND
  • Steinberg GD, Carter BS, Beaty TH, Childs B, Walsh PC. Family history and the risk of prostate cancer. Prostate. 1990;17(4):337-47. doi: 10.1002/pros.2990170409.

    PMID: 2251225BACKGROUND
  • Hayes RB, Liff JM, Pottern LM, Greenberg RS, Schoenberg JB, Schwartz AG, Swanson GM, Silverman DT, Brown LM, Hoover RN, et al. Prostate cancer risk in U.S. blacks and whites with a family history of cancer. Int J Cancer. 1995 Jan 27;60(3):361-4. doi: 10.1002/ijc.2910600315.

    PMID: 7829245BACKGROUND

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital Diseases

Study Officials

  • Elaine A Ostrander, Ph.D.

    National Human Genome Research Institute (NHGRI)

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Sponsor Type
NIH
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 19, 2006

First Posted

June 21, 2006

Study Start

November 8, 2004

Study Completion

July 30, 2018

Last Updated

August 1, 2018

Record last verified: 2018-07-30

Locations