Prostate Active Surveillance Study (PASS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT00756665
Recruitment Status : Recruiting
First Posted : September 22, 2008
Last Update Posted : November 9, 2017
Canary Foundation
Early Detection Research Network
Information provided by (Responsible Party):
Daniel Lin, University of Washington

September 18, 2008
September 22, 2008
November 9, 2017
July 2008
July 2022   (Final data collection date for primary outcome measure)
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Complete list of historical versions of study NCT00756665 on Archive Site
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Prostate Active Surveillance Study
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.

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.
Observational Model: Cohort
Time Perspective: Prospective
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Retention:   Samples With DNA
serum, plasma, white cells, DNA, urine, prostate tissue
Non-Probability Sample
Urology Clinic
Prostatic Neoplasms
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*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
July 2022
July 2022   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Histologically confirmed adenocarcinoma of the prostate.
  • 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 biopsy requirements:

    1. If diagnosis was within one year of baseline visit, participant must have at least one biopsy with at least 10 cores.
    2. If diagnosis was more than 1 year prior to baseline visit, participant must have a minimum of 2 biopsies, one of which must be within 2 years prior to baseline visit.

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.
Sexes Eligible for Study: Male
21 Years and older   (Adult, Senior)
Contact: Lisa Newcomb, PhD
Canada,   United States
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Daniel Lin, University of Washington
University of Washington
  • Canary Foundation
  • Early Detection Research Network
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: Ian M. Thompson, MD University of Texas Health Science Center, San Antonio
Principal Investigator: Peter R. Carroll, MD University of California, San Francisco
Principal Investigator: Michael D. Fabrizio, 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
Study Director: Lisa F Newcomb, PhD Fred Hutchinson Cancer Research Center/University of Washington
Principal Investigator: Christopher P Filson, MD Emory University
University of Washington
November 2017