C61
Conditions
Interventions
Group 1: - Almost all in Germany with HIFU-treated patients should be included about 1000 patients
- All cases to be documented for the observation of the application are carried out with the devices
Sponsors
o Universitätsklinik für Urologie, Uroonkologie, robotergestützte und fokale Therapie
Eligibility
Sex/Gender
Male
Age
18 Years to No maximum
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall survival of patients 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
| Measure | Time frame |
|---|---|
| - Tumor-specific survival - Analysis of the acute and late toxicity of the procedure (effectiveness and effectiveness of HIFU therapy) 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. | — |
Countries
Germany
Contacts
Public ContactAlexander Fehr
o Universitätsklinik für Urologie, Uroonkologie, robotergestützte und fokale Therapie
Outcome results
None listed