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Canary Prostate Active Surveillance Study


N/A
21 Years
N/A
Open (Enrolling)
Male
Prostatic Neoplasms

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Trial Information

Canary Prostate Active Surveillance Study


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.


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.

Type of Study:

Observational

Study Design:

Observational Model: Cohort, Time Perspective: Prospective

Principal Investigator

Daniel W. Lin, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Washington

Authority:

United States: Institutional Review Board

Study ID:

33567-K

NCT ID:

NCT00756665

Start Date:

July 2008

Completion Date:

July 2018

Related Keywords:

  • Prostatic Neoplasms
  • prostate
  • cancer
  • Neoplasms
  • Prostatic Neoplasms

Name

Location

University of MichiganAnn Arbor, Michigan  48109-0624
Stanford UniversityStanford, California  94305
Eastern Virginia Medical SchoolNorfolk, Virginia  23507
University of WashingtonSeattle, Washington  98195
University of California, San FranciscoSan Francisco, California  94143
Beth Israel Deaconess Medical Center/Harvard Medical SchoolBoston, Massachusetts  02115
University of Texas Health Science Center, San AntonioSan Antonio, Texas  78229
Veterans Affairs Puget Sound Health Care SystemSeattle, Washington  98108