Recruiting

Observational Study

Sponsor:

University of Washington

Code:

NCT00756665

Conditions

Prostatic Neoplasms

Eligibility Criteria

Sex: Male

Age: 21+

Healthy Volunteers: Not accepted

Study Details

Brief summary:

The Prostate Active Surveillance Study (PASS) is a research study for men who have chosen active surveillance as a management plan for their prostate cancer. Active surveillance is defined as close monitoring of prostate cancer with the offer of treatment if there are changes in test results. This study seeks to discover markers that will identify cancers that are more aggressive from those tumors that grow slowly.

Conditions

Prostatic Neoplasms

Study ID

NCT00756665

Start date

Jul, 2008

Status verified date

Aug, 2026

Completion date

Sep, 2032

Anticipated

Primary completion date

Sep, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Male

Age: 21+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Histologically confirmed adenocarcinoma of the prostate from a prostate biopsy.
  • Clinically localized prostate cancer: T1-2, NX or N0, MX or M0.
  • No previous treatment for prostate cancer (including hormonal therapy, radiation therapy, surgery, or chemotherapy).
  • ECOG Performance Status 0 or 1.
  • Patient has elected Active Surveillance as preferred management plan for prostate cancer.
  • Patient consent has been obtained according to local Institutional Review Board for acquisition of research specimens.
  • Patient is accessible and compliant for follow-up.
  • Prostate cancer diagnosis cannot be more than 3 years prior to baseline visit date.
  • No more than two prostate biopsies including the initial biopsy in which cancer was diagnosed.
  • If cancer diagnosis is more than one year before enrollment, there must be two prostate biopsies including the initial biopsy in which cancer was diagnosed and a subsequent biopsy. The subsequent biopsy may occur on the same day as the baseline visit.
  • Biopsies must have at least 10 cores.

Exclusion Criteria:

  • Unwillingness or inability to undergo serial prostate biopsy.
  • History of other malignancies, except: adequately treated non-melanoma skin cancer or adequately treated superficial bladder cancer (Ta) or other solid tumors curatively treated with no evidence of disease for > 5 years.

Study Design

Enrollment

3000 participants

Anticipated

Interventions and Outcome Measures

Central Contacts and Locations

Central contacts

Lisa Newcomb, PhD

lnewcomb@fredhutch.org

Locations

Veterans Affairs San Francisco Health Care System

Recruiting

San Francisco, California, United States, 94121

Contacts

Chloe Chan

858-537-4540chloe.chan@va.gov

Principal Investigator:

Matthew R. Cooperberg, MD, MPH

University of California, San Francisco

Recruiting

San Francisco, California, United States, 94143

Contacts

Imelda Tenggara-Hunter

415-353-7348Imelda.Tenggara@ucsf.edu

Principal Investigator:

Peter R. Carroll, MD, MPH

Stanford University

Recruiting

Stanford, California, United States, 94305

Contacts

Ned Realiza

650.498.8496nrealiza@stanford.edu

Principal Investigator:

James D. Brooks, MD

Emory University

Recruiting

Atlanta, Georgia, United States, 30322

Contacts

Shelby McAlister

256-702-3471sjmcali@emory.edu

Principal Investigator:

Martin G. Sanda, MD

Beth Israel Deaconess Medical Center/Harvard Medical School

Recruiting

Boston, Massachusetts, United States, 02215

Contacts

Gabriela NietoBlanco

(617) 632-1047gnietobl@bidmc.harvard.edu

Principal Investigator:

Andrew A. Wagner, MD

University of Michigan

Recruiting

Ann Arbor, Michigan, United States, 48105

Contacts

Amy Kasputis

734-647-3411amgursky@med.umich.edu

Principal Investigator:

Todd M. Morgan, MD

University of Texas Health Science Center, San Antonio

Recruiting

San Antonio, Texas, United States, 78229

Contacts

Rafael Sanchez

210-450-8272sanchezr17@uthscsa.edu

Principal Investigator:

Michael A. Liss, MD, MAS

Eastern Virginia Medical School

Recruiting

Norfolk, Virginia, United States, 23502

Contacts

April Whitley

757-452-3460awhitley@urologyofva.net

Principal Investigator:

Robert W. Given, MD

Veterans Affairs Puget Sound Health Care System

Recruiting

Seattle, Washington, United States, 98108

Contacts

Branda Levchak

206-277-4760Branda.Levchak@va.gov

Principal Investigator:

Atreya Dash, MD

University of Washington

Recruiting

Seattle, Washington, United States, 98195

Contacts

Chenee Holcomb

206-598-0850cnh3@uw.edu

Principal Investigator:

Daniel W. Lin, MD

University of British Columbia

Recruiting

Vancouver, British Columbia, Canada, V5Z 1M9

Contacts

Jonathan Ma

604-875-5675jma@prostatecentre.com

Principal Investigator:

Martin E. Gleave, MD

More Information

Sponsor

University of Washington

Last update posted

Sep 2, 2026

Last verified

Aug, 2026

Keywords

  • prostate
  • cancer

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of Washington on 2026-09-02.