prostate cancer C61
Conditions
Interventions
Group 1: Hemiablation the prostate by HIFU
Sponsors
Universitätsklinikum Regensburg
Eligibility
Sex/Gender
Male
Age
19 Years to No maximum
Inclusion criteria
Inclusion criteria: • Patients aged > 18 years • Bioptic secured prostate cancer • Clinical stage T1c - T2a • PSA <= 10 ng/ml • Gleason Score <= 7a (3+4) • One-sided tumor attack • Proportion of infected tumor stamp in the total number of stamp of collected stamp <30% and the largest continuous tumor stove <5 mm • Height of the peripheral zone of the prostate to be treated in TRUS: o = 30 mm when treated with Ablatherm Integrated Imaging o = 40 mm when treatment with Focal One • No evidence of significant carcinoma of the opposite side in multiparametric MRI (defined as PI-RADS score 4 and 5) • Thickness of the rectal wall <6 mm in TRUS • Willingness of the participant to attend all follow-up visits (for 12 months)
Exclusion criteria
Exclusion criteria: - Previous therapie of prostate cancer as radiation, hormonotherapy (including bilateral orchiectomy and plastic orchiectomy) - Previous surgery of prostate and urethra within the last 6 month (TUR-prostate, urethrotomy, bladder neck incision) - Taking of 5-alpha-reductase inhibitors (finasteride or dutasteride) within the last 6 month - Stenosis of the rectum - Acute urinary tract infection - Acute bleeding coagulopathy - Allergy of latex - Participation of another clinical or pharmacological trial during the last 30 days
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| No initiation of definitive therapy (radical prostatectomy, radiation, complete HIFU, cryotherapy, hormone therapy) after one year | — |
Secondary
| Measure | Time frame |
|---|---|
| • Criteria for the study participants to qualified for an Active Surveillancen within the observation period. After following criteria, an AS must be vacated: - Gleason score> 6 - PSA doubling time T2a • Bioptic tumor freedom after 1 year - The treated prostate half - The untreated prostate half • Overall survival (defined as time to death of any cause) [Time Frame: 1 year] • Prostate cancer-specific survival (defined as time to death due to prostate cancer) [Time Frame: 1 year] • Morbidity [Time Frame: 1 year]: - Continence : - Changes in the ICS male SF-Score - Micturition : - Changes in IPSS-Score - Potency: - Changes in the IIEF 5-Score - Quality of life : - Changes in the EORTC QLQ 30 (version 3.0) - Anxiety and psychological distress : - Change in HADS ( Hospital Anxiety and Depression Scale ) • Security [Time Frame: 1 year]: - The incidence of all side effects during and after treatment, which associated with the treatment | — |
Countries
Germany
Contacts
Public ContactRoman Ganzer
Klinik und Poliklinik für Urologie, Universitätsklinikum Leipzig AöR
Outcome results
None listed