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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.
 
ClinicalTrials.gov Identifier: NCT00756665
Recruitment Status : Recruiting
First Posted : September 22, 2008
Last Update Posted : July 7, 2022
Sponsor:
Collaborators:
Canary Foundation
Early Detection Research Network
Information provided by (Responsible Party):
Daniel Lin, University of Washington

Tracking Information
First Submitted Date September 18, 2008
First Posted Date September 22, 2008
Last Update Posted Date July 7, 2022
Study Start Date July 2008
Estimated Primary Completion Date September 2024   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures Not Provided
Original Primary Outcome Measures Not Provided
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Prostate Active Surveillance Study
Official Title Canary Prostate Active Surveillance Study
Brief Summary 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.
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.
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:
serum, plasma, white cells, DNA, urine, prostate tissue
Sampling Method Non-Probability Sample
Study Population Urology Clinic
Condition Prostatic Neoplasms
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: July 5, 2022)
2500
Original Estimated Enrollment
 (submitted: September 18, 2008)
400
Estimated Study Completion Date September 2029
Estimated Primary Completion Date September 2024   (Final data collection date for primary outcome measure)
Eligibility Criteria

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.
Sex/Gender
Sexes Eligible for Study: Male
Ages 21 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Lisa Newcomb, PhD lnewcomb@fredhutch.org
Listed Location Countries Canada,   United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT00756665
Other Study ID Numbers 33567
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Current Responsible Party Daniel Lin, University of Washington
Original Responsible Party Daniel W. Lin, University of Washington
Current Study Sponsor University of Washington
Original Study Sponsor Same as current
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: Peter R. Carroll, MD University of California, San Francisco
Principal Investigator: Frances M. Martin, 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
PRS Account University of Washington
Verification Date July 2022