Prostate Active Surveillance Study



Status:Recruiting
Conditions:Prostate Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:21 - Any
Updated:12/13/2018
Start Date:July 2008
End Date:July 2022
Contact:Lisa Newcomb, PhD
Email:lnewcomb@fredhutch.org

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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.

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.
We found this trial at
10
sites
500 S State St
Ann Arbor, Michigan 48109
(734) 764-1817
Principal Investigator: Todd M. Morgan, MD
Phone: 248-252-5611
University of Michigan The University of Michigan was founded in 1817 as one of the...
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201 Dowman Dr
Atlanta, Georgia 30303
(404) 727-6123
Principal Investigator: Christopher P Filson, MD
Phone: 404-778-7397
Emory University Emory University, recognized internationally for its outstanding liberal artscolleges, graduate and professional schools,...
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Atlanta, GA
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Norfolk, Virginia 23507
Principal Investigator: Frances M. Martin, MD
Phone: 757-452-3464
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Norfolk, VA
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4502 Medical Drive
San Antonio, Texas 78284
(210) 567-7000
Principal Investigator: Ian M. Thompson, MD
Phone: 210-450-0705
University of Texas Health Science Center at San Antonio The University of Texas Health Science...
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Seattle, Washington 98104
(206) 543-2100
Principal Investigator: Daniel W. Lin, MD
Phone: 206-598-0850
Univ of Washington Founded in 1861 by a private gift of 10 acres in what...
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Boston, Massachusetts 02115
Principal Investigator: Andrew A. Wagner, MD
Phone: 617-667-2898
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Boston, MA
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San Francisco, California 94143
Principal Investigator: Peter R. Carroll, MD
Phone: 415-353-7348
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San Francisco, CA
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Seattle, Washington 98108
Principal Investigator: Daniel W. Lin, MD
Phone: 206-277-4760
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Seattle, WA
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450 Serra Mall
Stanford, California 94305
(650) 723-2300
Principal Investigator: James D. Brooks, MD
Phone: 650-725-5543
Stanford University Stanford University, located between San Francisco and San Jose in the heart of...
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Vancouver, British Columbia V6T 1W5
Principal Investigator: Martin E. Gleave, MD
Phone: 604-875-4111
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