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Prostate Active Surveillance Study (PASS)

The Prostate Active Surveillance Study (PASS) is an observational research study for men with prostate cancer who have chosen active surveillance. Active surveillance means closely watching the cancer with the option for treatment if tests show changes. This study aims to find markers that can tell the difference between aggressive cancers and those that grow slowly. You may be able to join if you are a man aged 21 or older with prostate cancer that has not spread, and you have not had previous treatment for it. The study hopes to identify these markers and understand how many men on active surveillance experience cancer progression.

Study design
This is a multi-center, prospective observational study. It plans to enroll 3000 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Not specified.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT00756665

Prostate Active Surveillance Study

Recruiting
Not specifiedAges 21+Observational
University of Washington
~3,000 participants
Updated 2026-01-15 on ClinicalTrials.gov

At a glance

Recruiting sites
11 of 11 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring

A primary outcome measure isn't published for this study.

Conditions

Prostatic Neoplasms

Explore related trials

Prostate Carcinoma

Where it's being run

11 sites across 8 states
California3
Washington2
Georgia1
Massachusetts1
Michigan1
Texas1
Virginia1
British Columbia1

Study leadership

  • Daniel W. Lin, MD · PRINCIPAL_INVESTIGATOR · University of Washington
  • James D. Brooks, MD · PRINCIPAL_INVESTIGATOR · Stanford University
  • Martin E. Gleave, MD · PRINCIPAL_INVESTIGATOR · University of British Columbia
  • Michael Liss, MD · PRINCIPAL_INVESTIGATOR · The University of Texas Health Science Center at San Antonio
  • Peter R. Carroll, MD, MPH · PRINCIPAL_INVESTIGATOR · University of California, San Francisco
  • Robert W. Given, MD · PRINCIPAL_INVESTIGATOR · Eastern Virginia Medical School
  • Andrew A Wagner, MD · PRINCIPAL_INVESTIGATOR · Beth Israel Deaconess Medical Center/Harvard Medical School
  • Todd M. Morgan, MD · PRINCIPAL_INVESTIGATOR · University of Michigan
  • Lisa F Newcomb, PhD · STUDY_DIRECTOR · Fred Hutchinson Cancer Research Center/University of Washington
  • Martin G. Sanda, MD · PRINCIPAL_INVESTIGATOR · Emory University
  • Matthew R. Cooperberg, MD, MPH · PRINCIPAL_INVESTIGATOR · Veterans Affairs San Francisco Health Care System
  • Atreya Dash, MD · PRINCIPAL_INVESTIGATOR · Veterans Affairs Puget Sound Health Care System

Who to contact

Lisa Newcomb, PhD
[email protected]
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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.