Canary Prostate Active Surveillance Study
21 Years
N/A
Male
Prostatic Neoplasms
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 Michigan | Ann Arbor, Michigan 48109-0624 |
| Stanford University | Stanford, California 94305 |
| Eastern Virginia Medical School | Norfolk, Virginia 23507 |
| University of Washington | Seattle, Washington 98195 |
| University of California, San Francisco | San Francisco, California 94143 |
| Beth Israel Deaconess Medical Center/Harvard Medical School | Boston, Massachusetts 02115 |
| University of Texas Health Science Center, San Antonio | San Antonio, Texas 78229 |
| Veterans Affairs Puget Sound Health Care System | Seattle, Washington 98108 |
