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Clinical trial Recruiting at 11 sites Observational Ages 21 and up Men only

Monitoring prostate cancer in men choosing active surveillance

Official title: Canary Prostate Active Surveillance Study

Run by University of Washington · NCT00756665 · Data updated 2026-11-12

This study is trying to find out if certain markers can help tell the difference between aggressive and less serious prostate cancers in men who are choosing to monitor their condition instead of starting treatment right away.

Quick facts

Study typeObservational
Ages21 Years and up
SexMen only
Enrollment3000 (estimated)
SponsorUniversity of Washington
Academic / other
Drugs / interventionschemotherapy, radiation
Locations11 sites (San Francisco, California and 10 other locations)
StatusRecruiting
StartedJuly 2008
Main results expectedSeptember 2029
Study endsSeptember 2032
Registry record updatedSeptember 2, 2026
Trial IDNCT00756665 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates are men with histologically confirmed localized prostate cancer who have chosen active surveillance as their management plan.

Probably not a fit

Patients with advanced prostate cancer or those who have previously received treatment for prostate cancer will not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

The Prostate Active Surveillance Study (PASS) focuses on men who have opted for active surveillance as a management strategy for their localized prostate cancer. This multi-center, prospective study aims to identify biomarkers that differentiate aggressive prostate cancers from those that are less likely to progress. Participants undergo regular monitoring through PSA tests, digital rectal examinations, and biopsies, with treatment initiated if there are signs of disease progression. The study also seeks to evaluate the clinical predictors of progression and the long-term survival outcomes for these patients.

Why it matters

Potential benefit: If successful, this study could lead to improved identification of aggressive prostate cancers, allowing for more tailored treatment approaches.

How similar studies have gone: Other studies have shown promise in identifying biomarkers for prostate cancer progression, making this approach both relevant and potentially impactful.

Who can join: the full rules

Show full inclusion / exclusion criteria 
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.

Where it's running

  • Veterans Affairs San Francisco Health Care System
    San Francisco, California, United States     Recruiting
  • University of California, San Francisco
    San Francisco, California, United States     Recruiting
  • Stanford University
    Stanford, California, United States     Recruiting
  • Emory University
    Atlanta, Georgia, United States     Recruiting
  • Beth Israel Deaconess Medical Center/Harvard Medical School
    Boston, Massachusetts, United States     Recruiting
  • University of Michigan
    Ann Arbor, Michigan, United States     Recruiting
Show 5 more locations
  • University of Texas Health Science Center, San Antonio
    San Antonio, Texas, United States     Recruiting
  • Eastern Virginia Medical School
    Norfolk, Virginia, United States     Recruiting
  • Veterans Affairs Puget Sound Health Care System
    Seattle, Washington, United States     Recruiting
  • University of Washington
    Seattle, Washington, United States     Recruiting
  • University of British Columbia
    Vancouver, British Columbia, Canada     Recruiting

Study contacts

  • Principal investigator: Daniel W. Lin, MD — University of Washington
  • Study coordinator: Lisa Newcomb, PhD
  • Email: lnewcomb@fredhutch.org

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
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Prostatic Neoplasms 37University of Washington 1989
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.