Observational study of therapy with High Intensive Focused Ultrasound (HIFU) at Prostate Cancer
Recruiting
- Conditions
- C61Malignant neoplasm of prostate
- Registration Number
- DRKS00018103
- Lead Sponsor
- niversitätsklinik für Urologie und Kinderurologie
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Male
- Target Recruitment
- 1000
Inclusion Criteria
1. Patients with prostate cancer in whom a local therapy an improvement of disease situation promises
2. Consent to voluntary participation in the observational study after complete education on nature and purpose of observation, confirmed by signature on enlightenment document
Exclusion Criteria
1. Acute, untreated urinary tract infection
2. Pre-existing urinary or rectal fistula
3. Anal stenosis, the introduction of the HIFU transducer does not allow
Study & Design
- Study Type
- observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Overall survival of patients<br>There should be a follow-up at yearly intervals. For this purpose, dynamic progress sheets are created, which document a recurrence / progress by means of PSA course and possibly obtained control histology. Any imaging or clinical findings can be recorded.
- Secondary Outcome Measures
Name Time Method - Tumor-specific survival<br>- Analysis of the acute and late toxicity of the procedure (effectiveness and effectiveness of HIFU therapy)<br>The follow-up includes standardized questionnaires regarding micturition problems, general quality of life, continence and potency, and finally, concomitant or sequelae, in particular hospitalisation, surgical therapy or others are documented.