Focal therapy of localized prostate cancer using mpMRI/TRUS-guided high intensity focused ultrasound (HIFU) technology
Not Applicable
- Conditions
- C61Malignant neoplasm of prostate
- Registration Number
- DRKS00007105
- Lead Sponsor
- Klinik für Urologie, Universitätsmedizin Mannheim
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- Male
- Target Recruitment
- 50
Inclusion Criteria
Serum PSA: PSA < 10 ng/ml
mpMRT/TRUS bioptic proven prostate cancer:
- Clinical stage: T1c, unifocal
- Gleason score = 3 + 4
Life expectancy > 10 yr
Exclusion Criteria
Previous treatment:
Previous treatment of the primary cancer within the prostate
Previous hormone treatment for prostate cancer within 6 months before trial
Previous radiation to pelvis
Active urinary tract infection
One or more of the following findings in multiparametric MRI:
PI-RADS score < 3 of the treatment lesion
PI-RADS score > 3 of opposite site
Extracapsular extension or seminal vesicle invasion
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Focal ablation of prostate cancer lesion with negative mpMRI/TRUS fused biopsy at 12 mo after treatment
- Secondary Outcome Measures
Name Time Method - 5-year secondary treatment free time<br>- Biochemical treatment failure<br>- Metastatic-free survival<br>- Cancer-specific mortality<br>- Overall mortality<br>- Functional outcome (incontinence voiding, erectile dysfunction, quality of life, anxiety)<br>- Clinical validity of mpMRI to analyse the presence of residual or recurrent cancer compared with histopathologic findings using mpMRT/TRUS-guided prostate biopsy<br>- 5-year costs of treatment<br>- 60-day postoperative complications using Clavien-Dingo grading system<br>