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Prostate Active Surveillance Study (PASS)

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2013 by University of Washington
Sponsor:
Collaborators:
Canary Foundation
Early Detection Research Network
Information provided by (Responsible Party):
Daniel Lin, University of Washington
ClinicalTrials.gov Identifier:
NCT00756665
First received: September 18, 2008
Last updated: December 16, 2013
Last verified: December 2013

September 18, 2008
December 16, 2013
July 2008
July 2018   (final data collection date for primary outcome measure)
Not Provided
Not Provided
Complete list of historical versions of study NCT00756665 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
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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
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Retention:   Samples With DNA
Description:

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

Non-Probability Sample

Urology Clinic

Prostatic Neoplasms
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
1000
July 2018
July 2018   (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.
Male
21 Years and older
No
United States,   Canada
 
NCT00756665
33567-K
Yes
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: Raymond S Lance, MD Eastern Virginia Medical School
Principal Investigator: Andrew A Wagner, MD Beth Israel Deaconess Medical Center/Harvard Medical School
Principal Investigator: John T Wei, MD, MS University of Michigan
Study Director: Lisa F Newcomb, PhD Fred Hutchinson Cancer Research Center/University of Washington
University of Washington
December 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP