Early Stage Prostate Cancer Cohort

NCT00011349 | Completed

• 1 other identifier: 719B
• Study Type: observational
• Target: 1,116
• Locations: 1 country
• Sites: 13

Brief Summary

Environmental factors such as diet and cigarette smoking may play a role in predicting the progression of early stage prostate cancer to advance disease. The goal of this project is to establish an observational cohort of patients with early stage prostate cancer who elect not to undergo radical prostatectomy or radiation therapy to evaluate risk factors which predict the transformation of early stage to clinically aggressive disease.

Conditions

Prostate Cancer

Keywords

Prostate Cancer

Outcome Measures

Primary Outcomes (1)

• The primary endpoint of the study will be prostate cancer mortality.

  approximately once a year

Study Arms (1)

Group 1

Eligibility Criteria

• Sex: male
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

We propose to establish an observational cohort of 1000 US male veterans from 10-12 VAMC with early stage prostate cancer with no known distant metastases.

You may qualify if:

• US male veterans with early stage prostate cancer.

You may not qualify if:

• Men will be excluded if they have prior history of other cancer within the last 5 years (with the exception of non-melanoma skin cancer) or other major illness that would preclude long-term participation.

Sponsors & Collaborators

• US Department of Veterans Affairs: lead

Study Sites (13)

Southern Arizona VA Health Care System, Tucson

Tucson, Arizona, 85723, United States

Location

VA Medical Center, Long Beach

Long Beach, California, 90822, United States

Location

VA Medical Center, DC

Washington D.C., District of Columbia, 20422, United States

Location

James A. Haley Veterans Hospital, Tampa

Tampa, Florida, 33612, United States

Location

VA Medical Center, Jamaica Plain Campus

Boston, Massachusetts, 02130, United States

Location

VA Medical Center, Kansas City MO

Kansas City, Missouri, 64128, United States

Location

VA Medical Center, St Louis

St Louis, Missouri, 63106, United States

Location

VA Medical Center, Northport

Northport, New York, 11768, United States

Location

VA Medical Center, Syracuse

Syracuse, New York, 13210, United States

Location

VA Pittsburgh Health Care System

Pittsburgh, Pennsylvania, 15240, United States

Location

Michael E. DeBakey VA Medical Center (152)

Houston, Texas, 77030, United States

Location

Hunter Holmes McGuire VA Medical Center

Richmond, Virginia, 23249, United States

Location

VA Medical Center, Huntington

Huntington, West Virginia, 25704, United States

Location

Related Publications (1)

• Farwell WR, Lourenco C, Holmberg E, Hall RB, D'Avolio L, Lawler EV, Michael Gaziano J. The association between height and prostate cancer grade in the Early Stage Prostate Cancer Cohort Study. Cancer Causes Control. 2011 Oct;22(10):1453-9. doi: 10.1007/s10552-011-9820-x. Epub 2011 Jul 20.

  PMID: 21773817 RESULT

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Officials

• Michael J. Gaziano, MD MOH

  VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 15, 2001
• First Posted: February 19, 2001
• Study Start: January 1, 2001
• Primary Completion: June 1, 2006
• Study Completion: January 1, 2010
• Last Updated: April 15, 2013

Record last verified: 2013-04

Locations

US (13)