Feasibility of focal treatment of localized prostate cancer with MRI / TRUS image fusion using the Focal One

Not Applicable

Recruiting

Conditions: prostate cancer
C61
Malignant neoplasm of prostate

Registration Number: DRKS00007775

Lead Sponsor: niversitätsklinik für Urologie und Kinderurologie

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Male

Target Recruitment: 60

Inclusion Criteria

Life expectancy> 10 years, PSA <= 15 ng / ml, clinically localized prostate cancer, the number of infested punching <= 30% of the extracted stamping cylinder, Gleason score <= 3 + 4 = 7, normal anal and rectal anatomy, maximum 2 in mpMRT visible lesions with PI-RADS score 4/5, rejection of also featured standard therapies, at least a visible lesion in mpMRT with a PI-RADS score 4/5, Accordance suspect mpMRT-areas with areas of positive punching

Exclusion Criteria

not limited clinical tumor stage, evidence of lymph node or distant metastases in the imaging, more than 2 visible MRI lesions with PI-RADS 4/5, no suspicious MRI lesion (PI RAS 4/5) with positive punch in the same sector, existing Urethralstenosen, unresolved coagulopathy, untreated urogenital infections, latex allergies, contraindications to MRI (pacemaker, metal prostheses o. ä.), participating in a treatment study for prostate within the last 30 days, missing capacity to consent, ongoing antihormonal therapy, TURP in the last 6 months

Study & Design

Study Type: interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Bioptic tumor tissue of the treated areas within the MRI guided biopsy or MRI / TURS fusion biopsy after 6 month

Secondary Outcome Measures

Name	Time	Method
all at inclusion and FU visits Months 3, 6, 18, 24:<br>- Incontinence: changes in the ICS-male SF score - micturition: changes in IPSS score<br>- Potency: changes in IIEF-5 score<br>- Quality of life: EORTC QLQ C30, Version 3.0<br>- Anxiety and psychological stress: changes in HADS-Scale<br><br>all at treatment and day of discharge and FU-months 1,3, 6, 12, 18, 24:<br>- Safety: detection of adverse reactions to Clavien-Dindo