RECRUITING

Prostate Active Surveillance Study

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Canary Prostate Active Surveillance Study

Quick Facts

Study Start:2008-07

Study Completion:2032-09

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT00756665

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:21 Years

Sexes Eligible for Study:MALE

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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.	* 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.

Inclusion Criteria

Exclusion 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.

* 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

Study Contact

Lisa Newcomb, PhD

CONTACT

lnewcomb@fredhutch.org

Principal Investigator

Daniel W. Lin, MD

PRINCIPAL_INVESTIGATOR

University of Washington

James D. Brooks, MD

PRINCIPAL_INVESTIGATOR

Stanford University

Martin E. Gleave, MD

PRINCIPAL_INVESTIGATOR

University of British Columbia

Michael Liss, MD

PRINCIPAL_INVESTIGATOR

University of Texas Health Science Center, San Antonio

Peter R. Carroll, MD, MPH

PRINCIPAL_INVESTIGATOR

University of California, San Francisco

Robert W. Given, MD

PRINCIPAL_INVESTIGATOR

Eastern Virginia Medical School

Andrew A Wagner, MD

PRINCIPAL_INVESTIGATOR

Beth Israel Deaconess Medical Center/Harvard Medical School

Todd M. Morgan, MD

PRINCIPAL_INVESTIGATOR

University of Michigan

Lisa F Newcomb, PhD

STUDY_DIRECTOR

Fred Hutchinson Cancer Research Center/University of Washington

Martin G. Sanda, MD

PRINCIPAL_INVESTIGATOR

Emory University

Matthew R. Cooperberg, MD, MPH

PRINCIPAL_INVESTIGATOR

Veterans Affairs San Francisco Health Care System

Atreya Dash, MD

PRINCIPAL_INVESTIGATOR

Veterans Affairs Puget Sound Health Care System

Study Locations (Sites)

Veterans Affairs San Francisco Health Care System

San Francisco, California, 94121

United States

University of California, San Francisco

San Francisco, California, 94143

United States

Stanford University

Stanford, California, 94305

United States

Emory University

Atlanta, Georgia, 30322

United States

Beth Israel Deaconess Medical Center/Harvard Medical School

Boston, Massachusetts, 02215

United States

University of Michigan

Ann Arbor, Michigan, 48105

United States

University of Texas Health Science Center, San Antonio

San Antonio, Texas, 78229

United States

Eastern Virginia Medical School

Norfolk, Virginia, 23502

United States

Veterans Affairs Puget Sound Health Care System

Seattle, Washington, 98108

United States

University of Washington

Seattle, Washington, 98195

United States

Collaborators and Investigators

Sponsor: University of Washington

Daniel W. Lin, MD, PRINCIPAL_INVESTIGATOR, University of Washington
James D. Brooks, MD, PRINCIPAL_INVESTIGATOR, Stanford University
Martin E. Gleave, MD, PRINCIPAL_INVESTIGATOR, University of British Columbia
Michael Liss, MD, PRINCIPAL_INVESTIGATOR, University of Texas Health Science Center, San Antonio
Peter R. Carroll, MD, MPH, PRINCIPAL_INVESTIGATOR, University of California, San Francisco
Robert W. Given, MD, PRINCIPAL_INVESTIGATOR, Eastern Virginia Medical School
Andrew A Wagner, MD, PRINCIPAL_INVESTIGATOR, Beth Israel Deaconess Medical Center/Harvard Medical School
Todd M. Morgan, MD, PRINCIPAL_INVESTIGATOR, University of Michigan
Lisa F Newcomb, PhD, STUDY_DIRECTOR, Fred Hutchinson Cancer Research Center/University of Washington
Martin G. Sanda, MD, PRINCIPAL_INVESTIGATOR, Emory University
Matthew R. Cooperberg, MD, MPH, PRINCIPAL_INVESTIGATOR, Veterans Affairs San Francisco Health Care System
Atreya Dash, MD, PRINCIPAL_INVESTIGATOR, Veterans Affairs Puget Sound Health Care System

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2008-07

Study Completion Date2032-09

Study Record Updates

Study Start Date2008-07

Study Completion Date2032-09

Terms related to this study

Keywords Provided by Researchers

prostate
cancer

Additional Relevant MeSH Terms

Prostatic Neoplasms