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Official Title

Canary Prostate Active Surveillance Study

Sponsor
University of Washington
Enrollment
3,000
Timeline
Jul 2008 → Sep 2032
About This 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.

Eligibility Criteria

Inclusion Criteria

  • 1Histologically confirmed adenocarcinoma of the prostate from a prostate biopsy.
  • 2Clinically localized prostate cancer: T1-2, NX or N0, MX or M0.
  • 3No previous treatment for prostate cancer (including hormonal therapy, radiation therapy, surgery, or chemotherapy).
  • 4ECOG Performance Status 0 or 1.
  • 5Patient has elected Active Surveillance as preferred management plan for prostate cancer.
  • 6Patient consent has been obtained according to local Institutional Review Board for acquisition of research specimens.
  • 7Patient is accessible and compliant for follow-up.
  • 8Prostate cancer diagnosis cannot be more than 3 years prior to baseline visit date.
  • 9No more than two prostate biopsies including the initial biopsy in which cancer was diagnosed.
  • 10If 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.
  • 11Biopsies must have at least 10 cores.

Exclusion Criteria

  • 1Unwillingness or inability to undergo serial prostate biopsy.
  • 2History 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.

Locations

11 sites participating in this study

Emory University

Atlanta, Georgia 30322

Recruiting

Martin G. Sanda, MD

Veterans Affairs San Francisco Health Care System

San Francisco, California 94121

Recruiting

Matthew R. Cooperberg, MD, MPH

University of California, San Francisco

San Francisco, California 94143

Recruiting

Peter R. Carroll, MD, MPH

Data sourced from ClinicalTrials.govView on ClinicalTrials.gov →