Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
3000 participants
OBSERVATIONAL
2008-07-31
2032-09-30
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
21 Years
MALE
No
Sponsors
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Canary Foundation
OTHER
Early Detection Research Network
NETWORK
University of Washington
OTHER
Responsible Party
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Daniel Lin
Professor, Urology
Principal Investigators
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Daniel W. Lin, MD
Role: PRINCIPAL_INVESTIGATOR
University of Washington
James D. Brooks, MD
Role: PRINCIPAL_INVESTIGATOR
Stanford University
Martin E. Gleave, MD
Role: PRINCIPAL_INVESTIGATOR
University of British Columbia
Michael Liss, MD
Role: PRINCIPAL_INVESTIGATOR
University of Texas Health Science Center San Antonio
Peter R. Carroll, MD, MPH
Role: PRINCIPAL_INVESTIGATOR
University of California, San Francisco
Robert W. Given, MD
Role: PRINCIPAL_INVESTIGATOR
Eastern Virginia Medical School
Andrew A Wagner, MD
Role: PRINCIPAL_INVESTIGATOR
Beth Israel Deaconess Medical Center/Harvard Medical School
Todd M. Morgan, MD
Role: PRINCIPAL_INVESTIGATOR
University of Michigan
Lisa F Newcomb, PhD
Role: STUDY_DIRECTOR
Fred Hutchinson Cancer Research Center/University of Washington
Martin G. Sanda, MD
Role: PRINCIPAL_INVESTIGATOR
Emory University
Matthew R. Cooperberg, MD, MPH
Role: PRINCIPAL_INVESTIGATOR
Veterans Affairs San Francisco Health Care System
Atreya Dash, MD
Role: PRINCIPAL_INVESTIGATOR
Veterans Affairs Puget Sound Health Care System
Locations
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Veterans Affairs San Francisco Health Care System
San Francisco, California, United States
University of California, San Francisco
San Francisco, California, United States
Stanford University
Stanford, California, United States
Emory University
Atlanta, Georgia, United States
Beth Israel Deaconess Medical Center/Harvard Medical School
Boston, Massachusetts, United States
University of Michigan
Ann Arbor, Michigan, United States
University of Texas Health Science Center, San Antonio
San Antonio, Texas, United States
Eastern Virginia Medical School
Norfolk, Virginia, United States
Veterans Affairs Puget Sound Health Care System
Seattle, Washington, United States
University of Washington
Seattle, Washington, United States
University of British Columbia
Vancouver, British Columbia, Canada
Countries
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Central Contacts
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Facility Contacts
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References
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Warlick CA, Allaf ME, Carter HB. Expectant treatment with curative intent in the prostate-specific antigen era: triggers for definitive therapy. Urol Oncol. 2006 Jan-Feb;24(1):51-7. doi: 10.1016/j.urolonc.2005.07.004.
Carter HB, Walsh PC, Landis P, Epstein JI. Expectant management of nonpalpable prostate cancer with curative intent: preliminary results. J Urol. 2002 Mar;167(3):1231-4.
Hardie C, Parker C, Norman A, Eeles R, Horwich A, Huddart R, Dearnaley D. Early outcomes of active surveillance for localized prostate cancer. BJU Int. 2005 May;95(7):956-60. doi: 10.1111/j.1464-410X.2005.05446.x.
Klotz L. Active surveillance with selective delayed intervention for favorable risk prostate cancer. Urol Oncol. 2006 Jan-Feb;24(1):46-50. doi: 10.1016/j.urolonc.2005.07.002.
Meng MV, Elkin EP, Harlan SR, Mehta SS, Lubeck DP, Carroll PR. Predictors of treatment after initial surveillance in men with prostate cancer: results from CaPSURE. J Urol. 2003 Dec;170(6 Pt 1):2279-83. doi: 10.1097/01.ju.0000094190.46523.b2.
Patel MI, DeConcini DT, Lopez-Corona E, Ohori M, Wheeler T, Scardino PT. An analysis of men with clinically localized prostate cancer who deferred definitive therapy. J Urol. 2004 Apr;171(4):1520-4. doi: 10.1097/01.ju.0000118224.54949.78.
Roemeling S, Roobol MJ, de Vries SH, Wolters T, Gosselaar C, van Leenders GJ, Schroder FH. Active surveillance for prostate cancers detected in three subsequent rounds of a screening trial: characteristics, PSA doubling times, and outcome. Eur Urol. 2007 May;51(5):1244-50; discussion 1251. doi: 10.1016/j.eururo.2006.11.053. Epub 2006 Dec 5.
Kattan MW, Eastham JA, Wheeler TM, Maru N, Scardino PT, Erbersdobler A, Graefen M, Huland H, Koh H, Shariat S, Slawin KM, Ohori M. Counseling men with prostate cancer: a nomogram for predicting the presence of small, moderately differentiated, confined tumors. J Urol. 2003 Nov;170(5):1792-7. doi: 10.1097/01.ju.0000091806.70171.41.
Steyerberg EW, Roobol MJ, Kattan MW, van der Kwast TH, de Koning HJ, Schroder FH. Prediction of indolent prostate cancer: validation and updating of a prognostic nomogram. J Urol. 2007 Jan;177(1):107-12; discussion 112. doi: 10.1016/j.juro.2006.08.068.
Other Identifiers
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RG4212000
Identifier Type: OTHER
Identifier Source: secondary_id
33567
Identifier Type: -
Identifier Source: org_study_id
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