Canary Prostate Active Surveillance Study
- 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.
Other eligibility criteria may apply.
- 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.
Other exclusion criteria may apply.