Status:
UNKNOWN
Active Surveillance for Prostate Cancer With Indolent Features
Lead Sponsor:
Assaf-Harofeh Medical Center
Conditions:
Prostate Cancer
Eligibility:
MALE
65-80 years
Brief Summary
In patients with prostate cancer with indolent features, disease progrssion may be very slow and in many cases will never become clinically evident during the patient's lifetime. Active surveillance i...
Eligibility Criteria
Inclusion
- Men 65 years of age or older who were diagnosed with prostate cancer in the past 3 month prior to inclusion
- Gleason's score of 6 or less.
- Clinical T1C per digital rectal exam.
- Pre biopsy PSA serum level of 6.0ng/ml or less.
- The presence of cancer in a single biopsy core of at least 8 taken.
- The presence of cancer in no more than 10% of the length of the core involved.
- 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.
- Israeli residence with the readiness to be available for the followup schedule.
Exclusion
- Patients who do not meet the above eligibility criteria
Key Trial Info
Start Date :
Trial Type :
OBSERVATIONAL
End Date :
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT00421265
Last Update
January 11 2007
Active Locations (1)
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1
Assaf Harofeh Medical Center
Ẕerifin, Israel, 70300