Canary Prostate Active Surveillance Study


Condition: Prostatic Neoplasms

Study Type: Observational

Clinical Trials Identifier NCT 8-digits: NCT00756665

Sponsor: University of Washington

Phase:

Eligibility:

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

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.

View trial on ClinicalTrials.gov