Active Surveillance for Prostate Cancer With Indolent Features
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ClinicalTrials.gov Identifier: NCT00421265
Verified January 2007 by Assaf-Harofeh Medical Center. Recruitment status was: Not yet recruiting
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 is a continuous process of monitoring disease characteristcs aiming to avoid the morbidity of active therapy in patients with stabe indolent parameters, while offering early detection of disease activity in others who will need active therapy to control their disease. We hypothesize that active surveillance will permit the avoidance of therapy related morbidity in the majority of appropriate patients and will be associated with maintaining their quality of life.
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Ages Eligible for Study:
65 Years to 80 Years (Adult, Senior)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
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.
Patients who do not meet the above eligibility criteria