Prostate Active Surveillance Study (PASS)

April 30, 2024 updated by: Daniel Lin, University of Washington

Canary Prostate Active Surveillance Study

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.

Study Overview

Status

Recruiting

Conditions

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.

Study Type

Observational

Enrollment (Estimated)

3000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Canada
    • British Columbia
      • Vancouver, British Columbia, Canada, V5Z 1M9
        • Recruiting
        • University of British Columbia
        • Principal Investigator:
          • Martin E. Gleave, MD
        • Contact:
  • United States
    • California
      • San Francisco, California, United States, 94143
        • Recruiting
        • University of California, San Francisco
        • Contact:
        • Principal Investigator:
          • Peter R. Carroll, MD, MPH
      • San Francisco, California, United States, 94121
        • Recruiting
        • Veterans Affairs San Francisco Health Care System
        • Contact:
        • Principal Investigator:
          • Matthew R. Cooperberg, MD, MPH
      • Stanford, California, United States, 94305
        • Recruiting
        • Stanford University
        • Contact:
        • Principal Investigator:
          • James D. Brooks, MD
    • Georgia
      • Atlanta, Georgia, United States, 30322
        • Recruiting
        • Emory University
        • Contact:
        • Contact:
        • Principal Investigator:
          • Martin G. Sanda, MD
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
        • Recruiting
        • Beth Israel Deaconess Medical Center/Harvard Medical School
        • Principal Investigator:
          • Andrew A. Wagner, MD
        • Contact:
    • Michigan
      • Ann Arbor, Michigan, United States, 48105
        • Recruiting
        • University of Michigan
        • Contact:
        • Principal Investigator:
          • Todd M. Morgan, MD
    • Texas
      • San Antonio, Texas, United States, 78229
        • Recruiting
        • University of Texas Health Science Center, San Antonio
        • Contact:
        • Principal Investigator:
          • Michael A. Liss, MD, MAS
    • Virginia
      • Norfolk, Virginia, United States, 23502
        • Recruiting
        • Eastern Virginia Medical School
        • Contact:
        • Principal Investigator:
          • Robert W. Given, MD
    • Washington
      • Seattle, Washington, United States, 98195
        • Recruiting
        • University of Washington
        • Principal Investigator:
          • Daniel W. Lin, MD
        • Contact:
          • Chenee Holcomb
          • Phone Number: 206-598-0850
          • Email: cnh3@uw.edu
      • Seattle, Washington, United States, 98108
        • Recruiting
        • Veterans Affairs Puget Sound Health Care System
        • Contact:
        • Principal Investigator:
          • Atreya Dash, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Urology Clinic

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Washington

Collaborators

Canary Foundation
Early Detection Research Network

Investigators

  • Principal Investigator: 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, University of Texas Health Science Center, San Antonio
  • Principal Investigator: Andrew A Wagner, MD, Beth Israel Deaconess Medical Center/Harvard Medical School
  • Principal Investigator: Todd M. Morgan, MD, University of Michigan
  • Study Director: Lisa F Newcomb, PhD, Fred Hutchinson Cancer Research Center/University of Washington
  • Principal Investigator: Peter R. Carroll, MD, MPH, University of California, San Francisco
  • Principal Investigator: Robert W. Given, MD, Eastern Virginia Medical School
  • Principal Investigator: 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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2008

Primary Completion (Estimated)

September 1, 2029

Study Completion (Estimated)

September 1, 2032

Study Registration Dates

First Submitted

September 18, 2008

First Submitted That Met QC Criteria

September 18, 2008

First Posted (Estimated)

September 22, 2008

Study Record Updates

Last Update Posted (Estimated)

May 2, 2024

Last Update Submitted That Met QC Criteria

April 30, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 33567
  • RG4212000 (Other Identifier: Fred Hutch/University of Washington Cancer Consortium)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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