Prostatic NeoplasmsPASSNCT00756665
Prostate Active Surveillance Study
An observational study of Prostatic Neoplasms, run by University of Washington at 11 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 years and older, men only
- Conditions the study is for
- Prostatic Neoplasms
- How many people
- 3,000 participants
- Where
- 11 sitesin 2 countries
- Study dates
- Jul 2008to Sep 2032
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Study population: Urology Clinic
Who may be able to join
- 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.
Show all 11Show fewer
- 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.
Who cannot join
- 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.
Trial locations and contacts
11 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
Lisa Newcomb, PhD contact
11 sites in 2 countries
United States10 sites, 10 recruiting
- Recruiting
University of Michigan
Ann Arbor, Michigan, 48105
Amy Kasputis, 734-647-3411, amgursky@med.umich.edu
Todd M. Morgan, MD
- Recruiting
Emory University
Atlanta, Georgia, 30322
Shelby McAlister, 256-702-3471, sjmcali@emory.edu
Martin G. Sanda, MD
- Recruiting
Beth Israel Deaconess Medical Center/Harvard Medical School
Boston, Massachusetts, 02215
Gabriela NietoBlanco, (617) 632-1047, gnietobl@bidmc.harvard.edu
Andrew A. Wagner, MD
- Recruiting
Eastern Virginia Medical School
Norfolk, Virginia, 23502
April Whitley, 757-452-3460, awhitley@urologyofva.net
Robert W. Given, MD
- Recruiting
University of Texas Health Science Center, San Antonio
San Antonio, Texas, 78229
Rafael Sanchez, 210-450-8272, sanchezr17@uthscsa.edu
Michael A. Liss, MD, MAS
- Recruiting
Veterans Affairs San Francisco Health Care System
San Francisco, California, 94121
Chloe Chan, 858-537-4540, chloe.chan@va.gov
Matthew R. Cooperberg, MD, MPH
- Recruiting
University of California, San Francisco
San Francisco, California, 94143
Imelda Tenggara-Hunter, 415-353-7348, Imelda.Tenggara@ucsf.edu
Peter R. Carroll, MD, MPH
- Recruiting
Veterans Affairs Puget Sound Health Care System
Seattle, Washington, 98108
Branda Levchak, 206-277-4760, Branda.Levchak@va.gov
Atreya Dash, MD
- Recruiting
University of Washington
Seattle, Washington, 98195
Chenee Holcomb, 206-598-0850, cnh3@uw.edu
Daniel W. Lin, MD
- Recruiting
Stanford University
Stanford, California, 94305
Ned Realiza, 650.498.8496, nrealiza@stanford.edu
James D. Brooks, MD
Canada1 site, 1 recruiting
- Recruiting
University of British Columbia
Vancouver, British Columbia, V5Z 1M9
Jonathan Ma, 604-875-5675, jma@prostatecentre.com
Martin E. Gleave, MD
About this study
Official title: Canary Prostate Active Surveillance Study
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.
Read the 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.
- Conditions
- Prostatic Neoplasms
- Keywords
- prostate, cancer
- Medical subject headings
- Prostatic Neoplasms, Neoplasms
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2008 (estimated)
- Study startJul 2008
- Primary completionSep 2029 (estimated)
- Study completionSep 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Prostatic NeoplasmsStudies of the same condition, open and under way.
- More trials run by University of WashingtonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 3,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Washington
- Sponsor type
- University, hospital or other
- Collaborators
- Canary Foundation, Early Detection Research Network
- Responsible party
- Principal investigator, Daniel Lin, University of Washington
- Investigators
- Daniel W. Lin, MD, Principal investigator, University of WashingtonJames D. Brooks, MD, Principal investigator, Stanford UniversityMartin E. Gleave, MD, Principal investigator, University of British ColumbiaMichael Liss, MD, Principal investigator, The University of Texas Health Science Center at San AntonioPeter R. Carroll, MD, MPH, Principal investigator, University of California, San FranciscoRobert W. Given, MD, Principal investigator, Eastern Virginia Medical SchoolAndrew A Wagner, MD, Principal investigator, Beth Israel Deaconess Medical Center/Harvard Medical SchoolTodd M. Morgan, MD, Principal investigator, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00756665
- Sponsor's protocol ID
- 33567
- Other IDs
- RG4212000
- Acronym
- PASS
- Status last verified
- Aug 2026
- First submitted
- 18 Sep 2008
- Last updated
- 2 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
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.
PubMed 16414495Carter 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.
PubMed 11832703Hardie 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.
PubMed 15839912Klotz 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.
PubMed 16414494Meng 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.
PubMed 14634396Patel 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.
PubMed 15017211Roemeling 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.
PubMed 17161520Kattan 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.
PubMed 14532778Steyerberg 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.
PubMed 17162015Chappidi MR, Newcomb LF, Zheng Y, Liu M, Schenk JM, Zhu K, de la Calle CM, Brooks JD, Carroll PR, Dash A, Filson CP, Gleave ME, Liss MA, Martin F, McKenney JK, Morgan TM, Wagner AA, Nelson PS, Lin DW. Magnetic Resonance Imaging at Second Surveillance Biopsy After Diagnosis in Patients With Grade Group 1 Prostate Cancer in the Canary Prostate Active Surveillance Study. J Urol. 2025 Sep;214(3):251-258. doi: 10.1097/JU.0000000000004592. Epub 2025 Apr 30.
PubMed 40305682
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Canary Prostate Active Surveillance Study
- ClinicalTrials.gov ID
- NCT00756665
- Acronym / sponsor ID
- PASS / 33567
- Conditions
- Prostatic Neoplasms
- Keywords
- prostate, cancer
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 3,000 participants (estimated)
- Lead sponsor
- University of WashingtonUniversity, hospital or other
- Collaborators
- Canary Foundation, Early Detection Research Network
- Study start
- Jul 2008
- Primary completion
- Sep 2029 (estimated)
- Study completion
- Sep 2032 (estimated)
- First posted
- 22 Sep 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 21 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Urology Clinic
Key inclusion criteria (11 listed)
- 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.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2026.
- Background: PubMed 16414495Warlick 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.
- Background: PubMed 11832703Carter 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.
- Background: PubMed 15839912Hardie 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.
- Background: PubMed 16414494Klotz 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.
- Background: PubMed 14634396Meng 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.
- Background: PubMed 15017211Patel 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.
- Background: PubMed 17161520Roemeling 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.
- Background: PubMed 14532778Kattan 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.
- Background: PubMed 17162015Steyerberg 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.
- Derived from this study: PubMed 40305682Chappidi MR, Newcomb LF, Zheng Y, Liu M, Schenk JM, Zhu K, de la Calle CM, Brooks JD, Carroll PR, Dash A, Filson CP, Gleave ME, Liss MA, Martin F, McKenney JK, Morgan TM, Wagner AA, Nelson PS, Lin DW. Magnetic Resonance Imaging at Second Surveillance Biopsy After Diagnosis in Patients With Grade Group 1 Prostate Cancer in the Canary Prostate Active Surveillance Study. J Urol. 2025 Sep;214(3):251-258. doi: 10.1097/JU.0000000000004592. Epub 2025 Apr 30.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Lisa Newcomb, PhD contact
Daniel W. Lin, MD principal investigator
University of Washington
James D. Brooks, MD principal investigator
Stanford University
Martin E. Gleave, MD principal investigator
University of British Columbia
11 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Prostatic Neoplasms, run by University of Washington at 11 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 2 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lisa Newcomb, PhD (lnewcomb@fredhutch.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00756665, which also lists 10 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Sep 2026.