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