C61
Conditions
Interventions
Group 1: 1. MRI of the prostate
2. Diagnosis of a localized prostate cancer
3. Examination of the inclusion and exclusion criteria
4. Information about the study and consent to participate in focal l
Sponsors
Otto-von-Guericke-Universität Magdeburg, Medizinische Fakultät
Eligibility
Sex/Gender
Male
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Voluntary written consent after verbal explanation for FLA 2. Men aged 18–80 years with a life expectancy of at least 10 years 3. PSA = 15ng / ml 4. Clinically localized prostate cancer 5. Correspondence of suspicious mpMRI areas (PI-RADS score 3-5) with areas of positive punches 6. Gleason score = 3 + 4 = 7a, ISUP category 1 or 2 7. Normal anal and rectal anatomy 8. Minimum distance of the carcinoma to the rectum 8mm 9. General anesthesia possible for patient (ASA status 1-2)
Exclusion criteria
Exclusion criteria: 1. Clinical tumor stage not locally limited 2. Punch biopsy carcinoma detection without MR correlate in the same sector 3. MRI lesions PI-RADS 3-5 that have not been clarified by a targeted biopsy 4. Existing urethral stenosis 5. Unresolved coagulation disorders 6. Untreated urogenital infections 7. Contraindication to magnetic resonance imaging 8. Participation in a therapy study on the prostate within the last 30 days 9. Lack of consent 10. Ongoing anti-hormonal therapy 11. Other oncological pretreatments of the prostate such as radiation or HIFU of the same area 12. Anti-androgen / androgen withdrawal therapy within the last 6 months 13. Ongoing other oncological therapy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Bioptic tumor freedom of the treated areas (infield) as part of an MRT / TRUS random + target fusion biopsy after 6 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Biopsy tumor freedom outside the treated areas as part of the control random biopsy or targeted biopsies in the mpMRI of newly emerged foci (outfield) Functional outcome: • Continence: o Changes in the ICS-male SF score • micturition: o Changes in the IPSS score • Potency: o Changes in the IIEF 5 score Life quality: • Changes in the EORTC QLQ 30 (version 3.0) Anxiety and psychological stress: • Change in HADS (Hospital Anxiety and Depression Scale) Security: • The occurrence of all treatment-related side effects during and after treatment according to Clavien-Dindo and CTCAE version 5.0 | — |
Countries
Germany
Contacts
Public ContactSimone Nitschke
Universitätsklinik für Urologie, Uroonkologie, robotergestützte und fokale Therapie
Outcome results
None listed