Prostate Active Surveillance Study - Full Text View

Sponsors and Collaborators:	University of Washington Canary Foundation Early Detection Research Network
Information provided by:	University of Washington
ClinicalTrials.gov Identifier:	NCT00756665

Purpose

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
Prostatic Neoplasms

MedlinePlus related topics: Cancer Prostate Cancer

U.S. FDA Resources

Study Type:	Observational
Study Design:	Cohort, Prospective
Official Title:	Canary Prostate Active Surveillance Study

Further study details as provided by University of Washington:

Biospecimen Retention: Samples With DNA

Biospecimen Description:

serum, plasma, white cells, DNA, urine, prostate tissue

Estimated Enrollment:	500
Study Start Date:	July 2008
Estimated Primary Completion Date:	July 2018 (Final data collection date for primary outcome measure)

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:

Biochemical progression
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.

Eligibility

Ages Eligible for Study:	21 Years and older
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

Urology Clinic

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00756665

Locations

United States, California
Stanford University	Recruiting
Stanford, California, United States, 94305
Contact: Michelle Ferrari, RN 650-725-5543 mferrari@stanford.edu
Principal Investigator: James D. Brooks, MD
University of California, San Francisco	Recruiting
San Francisco, California, United States, 94143
Contact: Imelda Tenggara-Hunter 415-353-7348 itenggara@urology.ucsf.edu
Principal Investigator: Peter R. Carroll, MD
United States, Texas
University of Texas Health Science Center, San Antonio	Recruiting
San Antonio, Texas, United States, 78229
Contact: Linda Hernandez, BSN, RN 210-450-1741 hernandezmh@uthscsa.edu
Principal Investigator: Ian M. Thompson, MD
United States, Washington
University of Washington	Recruiting
Seattle, Washington, United States, 98195
Contact: Sharon Downing, RN 206-598-0850 sdowning@u.washington.edu
Principal Investigator: Daniel W. Lin, MD
Canada, British Columbia
University of British Columbia	Recruiting
Vancouver, British Columbia, Canada, V5Z 1M9
Contact: Jonathan Ma 604-875-4111 ext 66557 jonathan.ma@vch.ca
Principal Investigator: Martin E. Gleave, MD

Sponsors and Collaborators

University of Washington

Canary Foundation

Early Detection Research Network

Investigators

Principal Investigator:	Daniel W. Lin, MD	University of Washington
Principal Investigator:	James D. Brooks, MD	Stanford University
Principal Investigator:	Martin E. Gleave, MD	University of British Columbia
Principal Investigator:	Ian M. Thompson, MD	University of Texas Health Science Center, San Antonio
Principal Investigator:	Peter R. Carroll, MD	University of California, San Francisco

More Information

Publications:

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. Review.

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.

Klotz L. Active surveillance with selective delayed intervention for favorable risk prostate cancer. Urol Oncol. 2006 Jan-Feb;24(1):46-50.

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.

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.

Roemeling S, Roobol MJ, de Vries SH, Wolters T, Gosselaar C, van Leenders GJ, Schröder 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. Epub 2006 Dec 5.

Kattan MW, Eastham JA, Wheeler TM, Maru N, Scardino PT, Erbersdobler A, Graefen M, Huland H, Koh H, Shariat SF, 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.

Steyerberg EW, Roobol MJ, Kattan MW, van der Kwast TH, de Koning HJ, Schröder FH. Prediction of indolent prostate cancer: validation and updating of a prognostic nomogram. J Urol. 2007 Jan;177(1):107-12; discussion 112.

Responsible Party:	University of Washington ( Daniel W. Lin )
Study ID Numbers:	33567-V
Study First Received:	September 18, 2008
Last Updated:	April 28, 2009
ClinicalTrials.gov Identifier:	NCT00756665 History of Changes
Health Authority:	United States: Institutional Review Board; Canada: Ethics Review Committee

Keywords provided by University of Washington:

prostate
cancer

Study placed in the following topic categories:

Prostatic Diseases
Genital Neoplasms, Male
Urogenital Neoplasms
Genital Diseases, Male
Prostatic Neoplasms

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Site
Prostatic Diseases
Genital Neoplasms, Male

Urogenital Neoplasms
Genital Diseases, Male
Prostatic Neoplasms

ClinicalTrials.gov processed this record on May 07, 2009