Trial Information
Prospective Cohort Study of Active Surveillance for Prostate Cancer With Indolent Linical Features
Inclusion Criteria:
1. Men 65 years of age or older who were diagnosed with prostate cancer in the past 3
month prior to inclusion
2. Gleason's score of 6 or less.
3. Clinical T1C per digital rectal exam.
4. Pre biopsy PSA serum level of 6.0ng/ml or less.
5. The presence of cancer in a single biopsy core of at least 8 taken.
6. The presence of cancer in no more than 10% of the length of the core involved.
7. Patient's consent to engage in active surveillance after being informed of the
benefits and potential risks of this approach as well as of alternative lines of
therapy.
8. Israeli residence with the readiness to be available for the followup schedule.
Exclusion Criteria:
Patients who do not meet the above eligibility criteria
Type of Study:
Observational
Study Design:
Observational Model: Defined Population, Observational Model: Natural History, Time Perspective: Longitudinal, Time Perspective: Prospective
Principal Investigator
Dan Leibovici, M.D.
Investigator Role:
Principal Investigator
Investigator Affiliation:
Assaf-Harofeh Medical Center
Authority:
Israel: Ministry of Health
Study ID:
138/06
NCT ID:
NCT00421265
Start Date:
Completion Date:
Related Keywords:
- Prostate Cancer
- prostate cancer
- active surveillance
- indolent features
- Prostatic Neoplasms