RecruitingObservational

Canary Prostate Active Surveillance Study

NCT ID: NCT00756665Sponsor: University of WashingtonLast updated: 2026-01-15

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.

Detailed description

This is a multi-center, prospective active surveillance study with selective intervention in patients with previously untreated, clinically localized prostate cancer at diagnosis. Candidates are assessed based on an extended core biopsy, serum PSA (including PSA kinetics, if available), digital rectal examination (DRE), and assessment of cancer grade and extent. Active surveillance is defined as serial PSA measurements and prostate examination with routine prostate biopsy and therapeutic intervention considered at the time one or more of the following: * Grade or volume progression * Clinical progression The objectives of the study are as follows: Primary Objective • To discover and confirm biomarkers that predict aggressive disease as defined by pre-specified histological, PSA, clinical criteria, or outcomes based on these variables. Secondary Objectives * To determine the proportion of patients on active surveillance who progress based on the above criteria. * To determine the clinical predictors of disease progression. * To measure the recurrence-free, disease-specific, and overall survival of men on active surveillance for clinically localized prostate cancer.

Eligibility criteria

Sex: MaleAge: 21 Years and olderHealthy volunteers: No

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 locations (10)

Veterans Affairs San Francisco Health Care System

San Francisco, California, 94121

Recruiting

Kristy Li · Contact

415-502-0696 Kristy.li@va.gov

Matthew R. Cooperberg, MD, MPH · Principal Investigator

University of California, San Francisco

San Francisco, California, 94143

Recruiting

Imelda Tenggara-Hunter · Contact

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

Peter R. Carroll, MD, MPH · Principal Investigator

Stanford University

Stanford, California, 94305

Recruiting

Ned Realiza · Contact

650.498.8496 nrealiza@stanford.edu

James D. Brooks, MD · Principal Investigator

Emory University

Atlanta, Georgia, 30322

Recruiting

Regan Bates · Contact

404-251-0636 regan.renee.bates@emory.edu

Martin G. Sanda, MD · Principal Investigator

Beth Israel Deaconess Medical Center/Harvard Medical School

Boston, Massachusetts, 02215

Recruiting

Gabriela NietoBlanco · Contact

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

Andrew A. Wagner, MD · Principal Investigator

University of Michigan

Ann Arbor, Michigan, 48105

Recruiting

Amy Kasputis · Contact

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

Todd M. Morgan, MD · Principal Investigator

University of Texas Health Science Center, San Antonio

San Antonio, Texas, 78229

Recruiting

Rafael Sanchez · Contact

210-450-8272 sanchezr17@uthscsa.edu

Michael A. Liss, MD, MAS · Principal Investigator

Eastern Virginia Medical School

Norfolk, Virginia, 23502

Recruiting

Amuktha Polkampally · Contact

757-452-3462 apolkampally@urologyofva.net

Robert W. Given, MD · Principal Investigator

Veterans Affairs Puget Sound Health Care System

Seattle, Washington, 98108

Recruiting

Branda Levchak · Contact

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

Atreya Dash, MD · Principal Investigator

University of Washington

Seattle, Washington, 98195

Recruiting

Chenee Holcomb · Contact

206-598-0850 cnh3@uw.edu

Daniel W. Lin, MD · Principal Investigator

References

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