Prostate Active Surveillance Study (PASS)

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ClinicalTrials.gov Identifier: NCT00756665

Recruitment Status : Recruiting

First Posted : September 22, 2008

Last Update Posted : February 27, 2023

See Contacts and Locations

View this study on Beta.ClinicalTrials.gov

Sponsor:

Collaborators:

Canary Foundation

Early Detection Research Network

Information provided by (Responsible Party):

Daniel Lin, University of Washington

Study Description

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.

Study Design

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Study Type :	Observational
Estimated Enrollment :	2500 participants
Observational Model:	Cohort
Time Perspective:	Prospective
Official Title:	Canary Prostate Active Surveillance Study
Study Start Date :	July 2008
Estimated Primary Completion Date :	September 2024
Estimated Study Completion Date :	September 2029

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Prostate cancer

MedlinePlus related topics: Prostate Cancer

U.S. FDA Resources

Groups and Cohorts

Outcome Measures

Biospecimen Retention: Samples With DNA

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

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:	21 Years and older (Adult, Older Adult)
Sexes 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00756665

Contacts

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Contact: Lisa Newcomb, PhD		lnewcomb@fredhutch.org

Locations

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United States, California
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
Stanford University	Recruiting
Stanford, California, United States, 94305
Contact: Ned Realiza 650-498-8496 nrealiza@stanford.edu
Principal Investigator: James D. Brooks, MD
United States, Georgia
Emory University	Recruiting
Atlanta, Georgia, United States, 30322
Contact: Bill Zheng 404-778-2258 bill.zheng@emory.edu
Contact: Leslie Gantt 404-778-7397 legantt@emory.edu
Principal Investigator: Christopher P Filson, MD
United States, Massachusetts
Beth Israel Deaconess Medical Center/Harvard Medical School	Recruiting
Boston, Massachusetts, United States, 02215
Contact: Catrina Crociani 617-667-2898 ccrocian@bidmc.harvard.edu
Principal Investigator: Andrew A. Wagner, MD
United States, Michigan
University of Michigan	Recruiting
Ann Arbor, Michigan, United States, 48105
Contact: Amy Kasputis 734-647-3411 amgursky@med.umich.edu
Principal Investigator: Todd M. Morgan, MD
United States, Texas
University of Texas Health Science Center, San Antonio	Recruiting
San Antonio, Texas, United States, 78229
Contact: Rafael Sanchez 210-450-8272 sanchezr17@uthscsa.edu
Principal Investigator: Michael A. Liss, MD, MAS
United States, Virginia
Eastern Virginia Medical School	Recruiting
Norfolk, Virginia, United States, 23502
Contact: Amy Bohannon 757-452-3821 abohannon@urologyofva.net
Principal Investigator: Frances M. Martin, MD
United States, Washington
Veterans Affairs Puget Sound Health Care System	Recruiting
Seattle, Washington, United States, 98108
Contact: Branda Levchak 206-277-4760 Branda.Levchak@va.gov
Principal Investigator: Daniel W. Lin, MD
University of Washington	Recruiting
Seattle, Washington, United States, 98195
Contact: Chenee Holcomb 206-598-0850 cnh3@uw.edu
Principal Investigator: Daniel W. Lin, MD
Canada, British Columbia
University of British Columbia	Recruiting
Vancouver, British Columbia, Canada, V5Z 1M9
Contact: George Chan 604-875-5003 gchan@prostatecentre.com
Principal Investigator: Martin E. Gleave, MD

Sponsors and Collaborators

University of Washington

Canary Foundation

Early Detection Research Network

Investigators

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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:	Michael Liss, MD	University of Texas Health Science Center, San Antonio
Principal Investigator:	Peter R. Carroll, MD	University of California, San Francisco
Principal Investigator:	Frances M. Martin, MD	Eastern Virginia Medical School
Principal Investigator:	Andrew A Wagner, MD	Beth Israel Deaconess Medical Center/Harvard Medical School
Principal Investigator:	Todd M. Morgan, MD	University of Michigan
Study Director:	Lisa F Newcomb, PhD	Fred Hutchinson Cancer Research Center/University of Washington
Principal Investigator:	Christopher P Filson, MD	Emory University

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. 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.

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Responsible Party:	Daniel Lin, Professor, Urology, University of Washington
ClinicalTrials.gov Identifier:	NCT00756665
Other Study ID Numbers:	33567 RG4212000 ( Other Identifier: Fred Hutch/University of Washington Cancer Consortium )
First Posted:	September 22, 2008 Key Record Dates
Last Update Posted:	February 27, 2023
Last Verified:	February 2023

Keywords provided by Daniel Lin, University of Washington:


prostate cancer

Additional relevant MeSH terms:

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Prostatic Neoplasms Genital Neoplasms, Male Urogenital Neoplasms Neoplasms by Site Neoplasms	Genital Diseases, Male Genital Diseases Urogenital Diseases Prostatic Diseases Male Urogenital Diseases

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