NCT00756665

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.

Trial Health

80
On Track

Trial Health Score

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

Enrollment
3,000

participants targeted

Target at P75+ for all trials

Timeline
77mo left

Started Jul 2008

Longer than P75 for all trials

Geographic Reach
2 countries

11 active sites

Status
recruiting

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 Progress74%
Jul 2008Sep 2032

Study Start

First participant enrolled

July 1, 2008

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

September 18, 2008

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 22, 2008

Completed
21 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2029

Expected
3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2032

Last Updated

January 15, 2026

Status Verified

January 1, 2026

Enrollment Period

21.2 years

First QC Date

September 18, 2008

Last Update Submit

January 13, 2026

Conditions

Prostatic Neoplasms

Keywords

prostatecancer

Eligibility Criteria

Age21 Years+
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Urology Clinic

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (11)

Veterans Affairs San Francisco Health Care System

San Francisco, California, 94121, United States

RECRUITING

University of California, San Francisco

San Francisco, California, 94143, United States

RECRUITING

Stanford University

Stanford, California, 94305, United States

RECRUITING

Emory University

Atlanta, Georgia, 30322, United States

RECRUITING

Beth Israel Deaconess Medical Center/Harvard Medical School

Boston, Massachusetts, 02215, United States

RECRUITING

University of Michigan

Ann Arbor, Michigan, 48105, United States

RECRUITING

University of Texas Health Science Center, San Antonio

San Antonio, Texas, 78229, United States

RECRUITING

Eastern Virginia Medical School

Norfolk, Virginia, 23502, United States

RECRUITING

Veterans Affairs Puget Sound Health Care System

Seattle, Washington, 98108, United States

RECRUITING

University of Washington

Seattle, Washington, 98195, United States

RECRUITING

University of British Columbia

Vancouver, British Columbia, V5Z 1M9, Canada

RECRUITING

Related Publications (10)

  • Warlick CA, Allaf ME, Carter HB. Expectant treatment with curative intent in the prostate-specific antigen era: triggers for definitive therapy. Urol Oncol. 2006 Jan-Feb;24(1):51-7. doi: 10.1016/j.urolonc.2005.07.004.

    PMID: 16414495BACKGROUND

  • Carter HB, Walsh PC, Landis P, Epstein JI. Expectant management of nonpalpable prostate cancer with curative intent: preliminary results. J Urol. 2002 Mar;167(3):1231-4.

    PMID: 11832703BACKGROUND

  • Hardie C, Parker C, Norman A, Eeles R, Horwich A, Huddart R, Dearnaley D. Early outcomes of active surveillance for localized prostate cancer. BJU Int. 2005 May;95(7):956-60. doi: 10.1111/j.1464-410X.2005.05446.x.

    PMID: 15839912BACKGROUND

  • Klotz L. Active surveillance with selective delayed intervention for favorable risk prostate cancer. Urol Oncol. 2006 Jan-Feb;24(1):46-50. doi: 10.1016/j.urolonc.2005.07.002.

    PMID: 16414494BACKGROUND

  • Meng MV, Elkin EP, Harlan SR, Mehta SS, Lubeck DP, Carroll PR. Predictors of treatment after initial surveillance in men with prostate cancer: results from CaPSURE. J Urol. 2003 Dec;170(6 Pt 1):2279-83. doi: 10.1097/01.ju.0000094190.46523.b2.

    PMID: 14634396BACKGROUND

  • Patel MI, DeConcini DT, Lopez-Corona E, Ohori M, Wheeler T, Scardino PT. An analysis of men with clinically localized prostate cancer who deferred definitive therapy. J Urol. 2004 Apr;171(4):1520-4. doi: 10.1097/01.ju.0000118224.54949.78.

    PMID: 15017211BACKGROUND

  • Roemeling S, Roobol MJ, de Vries SH, Wolters T, Gosselaar C, van Leenders GJ, Schroder FH. Active surveillance for prostate cancers detected in three subsequent rounds of a screening trial: characteristics, PSA doubling times, and outcome. Eur Urol. 2007 May;51(5):1244-50; discussion 1251. doi: 10.1016/j.eururo.2006.11.053. Epub 2006 Dec 5.

    PMID: 17161520BACKGROUND

  • Kattan MW, Eastham JA, Wheeler TM, Maru N, Scardino PT, Erbersdobler A, Graefen M, Huland H, Koh H, Shariat S, Slawin KM, Ohori M. Counseling men with prostate cancer: a nomogram for predicting the presence of small, moderately differentiated, confined tumors. J Urol. 2003 Nov;170(5):1792-7. doi: 10.1097/01.ju.0000091806.70171.41.

    PMID: 14532778BACKGROUND

  • Steyerberg EW, Roobol MJ, Kattan MW, van der Kwast TH, de Koning HJ, Schroder FH. Prediction of indolent prostate cancer: validation and updating of a prognostic nomogram. J Urol. 2007 Jan;177(1):107-12; discussion 112. doi: 10.1016/j.juro.2006.08.068.

    PMID: 17162015BACKGROUND

  • Chappidi MR, Newcomb LF, Zheng Y, Liu M, Schenk JM, Zhu K, de la Calle CM, Brooks JD, Carroll PR, Dash A, Filson CP, Gleave ME, Liss MA, Martin F, McKenney JK, Morgan TM, Wagner AA, Nelson PS, Lin DW. Magnetic Resonance Imaging at Second Surveillance Biopsy After Diagnosis in Patients With Grade Group 1 Prostate Cancer in the Canary Prostate Active Surveillance Study. J Urol. 2025 Sep;214(3):251-258. doi: 10.1097/JU.0000000000004592. Epub 2025 Apr 30.

    PMID: 40305682DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

serum, plasma, white cells, DNA, urine, prostate tissue

MeSH Terms

Conditions

Prostatic NeoplasmsNeoplasms

Condition Hierarchy (Ancestors)

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

Study Officials

  • Daniel W. Lin, MD

    University of Washington

    PRINCIPAL INVESTIGATOR

  • James D. Brooks, MD

    Stanford University

    PRINCIPAL INVESTIGATOR

  • Martin E. Gleave, MD

    University of British Columbia

    PRINCIPAL INVESTIGATOR

  • Michael Liss, MD

    The University of Texas Health Science Center at San Antonio

    PRINCIPAL INVESTIGATOR

  • Peter R. Carroll, MD, MPH

    University of California, San Francisco

    PRINCIPAL INVESTIGATOR

  • Robert W. Given, MD

    Eastern Virginia Medical School

    PRINCIPAL INVESTIGATOR

  • Andrew A Wagner, MD

    Beth Israel Deaconess Medical Center/Harvard Medical School

    PRINCIPAL INVESTIGATOR

  • Todd M. Morgan, MD

    University of Michigan

    PRINCIPAL INVESTIGATOR

  • Lisa F Newcomb, PhD

    Fred Hutchinson Cancer Research Center/University of Washington

    STUDY DIRECTOR

  • Martin G. Sanda, MD

    Emory University

    PRINCIPAL INVESTIGATOR

  • Matthew R. Cooperberg, MD, MPH

    Veterans Affairs San Francisco Health Care System

    PRINCIPAL INVESTIGATOR

  • Atreya Dash, MD

    Veterans Affairs Puget Sound Health Care System

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Lisa Newcomb, PhD

CONTACT

lnewcomb@fredhutch.org

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor, Urology

Study Record Dates

First Submitted

September 18, 2008

First Posted

September 22, 2008

Study Start

July 1, 2008

Primary Completion (Estimated)

September 1, 2029

Study Completion (Estimated)

September 1, 2032

Last Updated

January 15, 2026

Record last verified: 2026-01

Locations

US(10)CA(1)