Canary Prostate Active Surveillance Study

Condition: Prostatic Neoplasms

Study Type: Observational

Clinical Trials Identifier NCT 8-digits: NCT00756665

Sponsor: University of Washington



  • Age: minimum 21 Years maximum N/A
  • Gender: Male

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.

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