Clinical trial NCT00756665: Prostate Active Surveillance Study
Official title: Canary Prostate Active Surveillance Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Prostatic Neoplasms
Keywords: prostate
cancer
Lead sponsor: University of Washington
Sponsor class: OTHER
Collaborators: name: Canary Foundation
name: Early Detection Research Network
First posted: 2008-09-22
Enrollment: 3000
Sex: MALE
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Urology Clinic

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.

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.

Eligibility 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.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: Veterans Affairs San Francisco Health Care System
state: California
city: San Francisco
country: United States
facility: University of California, San Francisco
state: California
city: Stanford
country: United States
facility: Stanford University
state: California
city: Atlanta
country: United States
facility: Emory University
state: Georgia
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Center/Harvard Medical School
state: Massachusetts
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
city: San Antonio
country: United States
facility: University of Texas Health Science Center, San Antonio
state: Texas
city: Norfolk
country: United States
facility: Eastern Virginia Medical School
state: Virginia
city: Seattle
country: United States
facility: Veterans Affairs Puget Sound Health Care System
state: Washington
city: Seattle
country: United States
facility: University of Washington
state: Washington
city: Vancouver
country: Canada
facility: University of British Columbia
state: British Columbia
Study officials:
affiliation: University of Washington
name: Daniel W. Lin, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Stanford University
name: James D. Brooks, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of British Columbia
name: Martin E. Gleave, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Texas Health Science Center San Antonio
name: Michael Liss, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of California, San Francisco
name: Peter R. Carroll, MD, MPH
role: PRINCIPAL_INVESTIGATOR
affiliation: Eastern Virginia Medical School
name: Robert W. Given, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Beth Israel Deaconess Medical Center/Harvard Medical School
name: Andrew A Wagner, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Michigan
name: Todd M. Morgan, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Fred Hutchinson Cancer Research Center/University of Washington
name: Lisa F Newcomb, PhD
role: STUDY_DIRECTOR
affiliation: Emory University
name: Martin G. Sanda, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Veterans Affairs San Francisco Health Care System
name: Matthew R. Cooperberg, MD, MPH
role: PRINCIPAL_INVESTIGATOR
affiliation: Veterans Affairs Puget Sound Health Care System
name: Atreya Dash, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
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citation: 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.
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citation: 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.
citation: 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.