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NCT00756665 | RECRUITING | Prostatic Neoplasms

Prostate Active Surveillance Study
Sponsor:

University of Washington

Information provided by (Responsible Party):

Daniel Lin

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.

Condition or disease

Prostatic Neoplasms

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. * To measure the recurrence-free, disease-specific, and overall survival of men on active surveillance for clinically localized prostate cancer.

Study Type : OBSERVATIONAL
Estimated Enrollment : 3000 participants
Official Title : Canary Prostate Active Surveillance Study
Actual Study Start Date : 2008-07
Estimated Primary Completion Date : 2029-09
Estimated Study Completion Date : 2032-09

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 21 Years
Sexes Eligible for Study: MALE
Accepts Healthy Volunteers:
Criteria
Inclusion Criteria
  • * Histologically confirmed adenocarcinoma of the prostate from a prostate biopsy.
  • * 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 cancer diagnosis cannot be more than 3 years prior to baseline visit date.
  • * No more than two prostate biopsies including the initial biopsy in which cancer was diagnosed.
  • * If 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.
  • * Biopsies must have at least 10 cores.
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.
Prostate Active Surveillance Study

Location Details

NCT00756665

Please Choose a site

How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

RECRUITING

United States, California

Veterans Affairs San Francisco Health Care System

San Francisco, California, United States, 94121

RECRUITING

United States, California

University of California, San Francisco

San Francisco, California, United States, 94143

RECRUITING

United States, California

Stanford University

Stanford, California, United States, 94305

RECRUITING

United States, Georgia

Emory University

Atlanta, Georgia, United States, 30322

RECRUITING

United States, Massachusetts

Beth Israel Deaconess Medical Center/Harvard Medical School

Boston, Massachusetts, United States, 02215

RECRUITING

United States, Road cancer

University of Michigan

Ann Arbor, Road cancer, United States, 48105

RECRUITING

United States, Texas

University of Texas Health Science Center, San Antonio

San Antonio, Texas, United States, 78229

RECRUITING

United States, Virginia

Eastern Virginia Medical School

Norfolk, Virginia, United States, 23502

RECRUITING

United States, Washington

Veterans Affairs Puget Sound Health Care System

Seattle, Washington, United States, 98108

RECRUITING

United States, Washington

University of Washington

Seattle, Washington, United States, 98195

RECRUITING

Canada, British Columbia

University of British Columbia

Vancouver, British Columbia, Canada, V5Z 1M9