PASS: Prostate Active Surveillance Study
Study Details
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 | Intervention/Treatment | Phase |
|---|---|---|
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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:
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Grade or volume progression
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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
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To determine the proportion of patients on active surveillance who progress based on the above criteria.
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To determine the clinical predictors of disease progression.
Study Design
Outcome Measures
Primary Outcome Measures
Eligibility Criteria
Criteria
Inclusion Criteria:
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Histologically confirmed adenocarcinoma of the prostate.
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Clinically localized prostate cancer: T1-2, NX or N0, MX or M0.
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No previous treatment for prostate cancer (including hormonal therapy, radiation therapy, surgery, or chemotherapy).
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ECOG Performance Status 0 or 1.
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Patient has elected Active Surveillance as preferred management plan for prostate cancer.
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Patient consent has been obtained according to local Institutional Review Board for acquisition of research specimens.
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Patient is accessible and compliant for follow-up.
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Prostate biopsy requirements:
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If diagnosis was within one year of baseline visit, participant must have at least one biopsy with at least 10 cores.
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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:
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Unwillingness or inability to undergo serial prostate biopsy.
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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
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | University of California, San Francisco | San Francisco | California | United States | 94143 |
| 2 | Stanford University | Stanford | California | United States | 94305 |
| 3 | Emory University | Atlanta | Georgia | United States | 30322 |
| 4 | Beth Israel Deaconess Medical Center/Harvard Medical School | Boston | Massachusetts | United States | 02215 |
| 5 | University of Michigan | Ann Arbor | Michigan | United States | 48105 |
| 6 | University of Texas Health Science Center, San Antonio | San Antonio | Texas | United States | 78229 |
| 7 | Eastern Virginia Medical School | Norfolk | Virginia | United States | 23502 |
| 8 | Veterans Affairs Puget Sound Health Care System | Seattle | Washington | United States | 98108 |
| 9 | University of Washington | Seattle | Washington | United States | 98195 |
| 10 | University of British Columbia | Vancouver | British Columbia | Canada | V5Z 1M9 |
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: 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
Study Documents (Full-Text)
None provided.More Information
Publications
- 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.
- 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.
- 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.
- 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.
- 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.
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