Prostate Active Surveillance Study (PASS)

This study is currently recruiting participants.
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
  Purpose

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.


Condition
Prostatic Neoplasms

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Canary Prostate Active Surveillance Study

Resource links provided by NLM:


Further study details as provided by University of Washington:

Biospecimen Retention:   Samples With DNA

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


Estimated Enrollment: 1000
Study Start Date: July 2008
Estimated Study Completion Date: July 2018
Estimated Primary Completion Date: July 2018 (Final data collection date for primary outcome measure)
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.
  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Urology Clinic

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00756665

Locations
United States, California
University of California, San Francisco Recruiting
San Francisco, California, United States, 94143
Contact: Imelda Tenggara-Hunter    415-353-7348    itenggara@urology.ucsf.edu   
Contact: Hazel Dias    415-353-7790    HDias@urology.ucsf.edu   
Principal Investigator: Peter R. Carroll, MD         
Stanford University Recruiting
Stanford, California, United States, 94305
Contact: Michelle Ferrari, RN    650-725-5543    mferrari@stanford.edu   
Principal Investigator: James D. Brooks, MD         
United States, Massachusetts
Beth Israel Deaconess Medical Center/Harvard Medical School Recruiting
Boston, Massachusetts, United States, 02115
Contact: Andrew Wagner, MD    617-667-2898    awagner@bidmc.harvard.edu   
Principal Investigator: Andrew A. Wagner, MD         
United States, Michigan
University of Michigan Recruiting
Ann Arbor, Michigan, United States, 48105
Contact: Rabia Siddiqui    734-763-7508    rabia@med.umich.edu   
Principal Investigator: John T. Wei, MD, MS         
United States, Texas
University of Texas Health Science Center, San Antonio Recruiting
San Antonio, Texas, United States, 78229
Contact: Carol Lizcano, LVN, BS    210-450-0705    LizcanoC@uthscsa.edu   
Principal Investigator: Ian M. Thompson, MD         
United States, Virginia
Eastern Virginia Medical School Recruiting
Norfolk, Virginia, United States, 23502
Contact: Leigh Ann Brand, CCRP    757-457-5169    laallen@sentara.com   
Principal Investigator: Raymond S. Lance, MD         
United States, Washington
University of Washington Recruiting
Seattle, Washington, United States, 98195
Contact: Leslie Butler, LPN    206-598-0850    leslie@u.washington.edu   
Principal Investigator: Daniel W. Lin, MD         
Veterans Affairs Puget Sound Health Care System Recruiting
Seattle, Washington, United States, 98108
Contact: Branda Levchak    206-277-4760    Branda.Levchak@va.gov   
Principal Investigator: Daniel W. Lin, MD         
Canada, British Columbia
University of British Columbia Recruiting
Vancouver, British Columbia, Canada, V5Z 1M9
Contact: Jonathan Ma    604-875-4111 ext 66557    jonathan.ma@vch.ca   
Principal Investigator: Martin E. Gleave, MD         
Sponsors and Collaborators
University of Washington
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: 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
  More Information

Publications:

Responsible Party: Daniel Lin, Professor, Urology, University of Washington
ClinicalTrials.gov Identifier: NCT00756665     History of Changes
Other Study ID Numbers: 33567-K
Study First Received: September 18, 2008
Last Updated: December 16, 2013
Health Authority: United States: Institutional Review Board
Canada: Ethics Review Committee

Keywords provided by University of Washington:
prostate
cancer

Additional relevant MeSH terms:
Neoplasms
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Genital Diseases, Male
Prostatic Diseases

ClinicalTrials.gov processed this record on April 22, 2014