Prostate Active Surveillance Study (PASS)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00756665|
Recruitment Status : Recruiting
First Posted : September 22, 2008
Last Update Posted : February 27, 2023
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|Condition or disease|
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:
• To discover and confirm biomarkers that predict aggressive disease as defined by pre-specified histological, PSA, clinical criteria, or outcomes based on these variables.
- 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 Type :||Observational|
|Estimated Enrollment :||2500 participants|
|Official Title:||Canary Prostate Active Surveillance Study|
|Study Start Date :||July 2008|
|Estimated Primary Completion Date :||September 2024|
|Estimated Study Completion Date :||September 2029|
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
|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|
- 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:
- If diagnosis was within one year of baseline visit, participant must have at least one biopsy with at least 10 cores.
- 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.
- 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.
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
|Contact: Lisa Newcomb, PhDfirstname.lastname@example.org|
|United States, California|
|University of California, San Francisco||Recruiting|
|San Francisco, California, United States, 94143|
|Contact: Imelda Tenggara-Hunter 415-353-7348 email@example.com|
|Principal Investigator: Peter R. Carroll, MD|
|Stanford, California, United States, 94305|
|Contact: Ned Realiza 650-498-8496 firstname.lastname@example.org|
|Principal Investigator: James D. Brooks, MD|
|United States, Georgia|
|Atlanta, Georgia, United States, 30322|
|Contact: Bill Zheng 404-778-2258 email@example.com|
|Contact: Leslie Gantt 404-778-7397 firstname.lastname@example.org|
|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 email@example.com|
|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 firstname.lastname@example.org|
|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 email@example.com|
|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 firstname.lastname@example.org|
|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 email@example.com|
|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 firstname.lastname@example.org|
|Principal Investigator: Martin E. Gleave, MD|
|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|
|Responsible Party:||Daniel Lin, Professor, Urology, University of Washington|
|Other Study ID Numbers:||
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|
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