Prostate Active Surveillance Study

Prostatic Neoplasms Clinical Trial

— PASS  

Official title:

Canary Prostate Active Surveillance Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00756665
• Other study ID #: 33567
• Secondary ID: RG4212000
• Status: Recruiting
• Start date: July 2008
• Est. completion date: September 2032

Study information

• Verified date: April 2024
• Source: University of Washington
• Contact: Lisa Newcomb, PhD
• Email: lnewcomb[@]fredhutch.org
• Is FDA regulated: No
• Study type: Observational

Clinical 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. This study seeks to discover markers that will identify cancers that are more aggressive from those tumors that grow slowly.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 3000
• Est. completion date: September 2032
• Est. primary completion date: September 2029
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 21 Years and older

Eligibility

Inclusion Criteria:

• 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.
• 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.

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.

Related Conditions & MeSH terms

• Prostatic Neoplasms

Locations

Country	Name	City	State
Canada	University of British Columbia	Vancouver	British Columbia
United States	University of Michigan	Ann Arbor	Michigan
United States	Emory University	Atlanta	Georgia
United States	Beth Israel Deaconess Medical Center/Harvard Medical School	Boston	Massachusetts
United States	Eastern Virginia Medical School	Norfolk	Virginia
United States	University of Texas Health Science Center, San Antonio	San Antonio	Texas
United States	University of California, San Francisco	San Francisco	California
United States	Veterans Affairs San Francisco Health Care System	San Francisco	California
United States	University of Washington	Seattle	Washington
United States	Veterans Affairs Puget Sound Health Care System	Seattle	Washington
United States	Stanford University	Stanford	California

Sponsors (3)

Lead Sponsor	Collaborator
University of Washington	Canary Foundation, Early Detection Research Network

Countries where clinical trial is conducted

United States,  Canada, 

References & Publications (9)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation