Focal therapy of recurrent prostate cancer after external beam radiation therapy using mpMRI/TRUS-guided high intensity focused ultrasound (HIFU) technology (FOXPRO_RAD) – an initial pilot study
Not Applicable
- Conditions
- C61Malignant neoplasm of prostate
- Registration Number
- DRKS00009020
- Lead Sponsor
- Klinik für Urologie, Universitätsmedizin Mannheim
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Male
- Target Recruitment
- 15
Inclusion Criteria
Previous external beam radiation therapy of prostate cancer -Serum PSA: PSA = 10 ng/ml - mpMRT/TRUS bioptic proven recurrent prostate cancer radiation therapy: - Clinical stage: localized, unifocal - Gleason score = 4 + 3 - Life expectancy > 10 yr
Exclusion Criteria
urinary tract infection; metastases of prostate cancer
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Proportion of patients without residual tumor in the treated areal - Focal ablation of prostate cancer with negative mpMRI/TRUS fused biopsy at 12 mo after treatment
- Secondary Outcome Measures
Name Time Method Secondary treatment free time (5 years)<br>Biochemical treatment failure (lifelong)<br>Metastatic-free survival (lifelong)<br>Cancer-specific mortality (lifelong)<br>Overall mortality (lifelong)<br>Functional outcome (3 years)<br>Clinical validity of mpMRI to analyse the presence of residual or recurrent cancer compared with histopathologic findings using mpMRI/TRUS-guided prostate biopsy (12 months)<br>Assessment of safety: 60-day postoperative complications using Clavien-Dingo grading system <br>