Status:
UNKNOWN
Investigative Study of the Role of Focal Therapy for Prostate Cancer Treatment
Lead Sponsor:
Università Vita-Salute San Raffaele
Conditions:
Prostate Cancer
Eligibility:
MALE
18-76 years
Phase:
PHASE1
Brief Summary
Surgery and irradiation for organ confined prostate cancer provide excellent long-term cancer control but they may be accompanied by a risk of side effects that decrease quality of life. Due to the st...
Detailed Description
Prostate cancer is a considerable health risk for men throughout the world. In the United States, prostate cancer has been the second or third leading cause of cancer death in men in each of the last ...
Eligibility Criteria
Inclusion
- Clinical
- Clinical stage T1c or T2a
- PSA less than 10 ng/ml
- PSA velocity less than 2 ng/ml yearly in the year prior to diagnosis
- Biopsy
- Minimum of 12 cores
- No Gleason grade 4 or 5
- Maximum percentage of cancer in each core (20%)
- Maximum length of cancer in each core ( 5 mm)
- Maximum percentage of total cores with cancer (20%)
- Imaging
- Single lesion with a maximum size (12 mm)
- Maximum length of capsular contact (10 mm)
- No evidence of extraprostatic extension or seminal vesicle invasion
Exclusion
- Tumor in the transitional zone
- Previous prostate surgery for benign pathology
- Any rectal or perineal pathology hampering instrumentation and manipulation of the area
- Benign or malignant rectal lesion
- Any condition that in the judgment of the investigators would interfere with the subject's ability to provide informed consent, comply with study instructions, place the subject at increased risk, or which might confound interpretation of study results.
Key Trial Info
Start Date :
September 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2014
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT00928603
Start Date
September 1 2009
End Date
September 1 2014
Last Update
September 15 2009
Active Locations (1)
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1
Department of Urology University "Vita e Salute" HSR
Milan, Italy, 50127