Prospective phase II study of focal therapy (Hemiablation) of the prostate by high intensity focused ultrasound (HIFU) in patients with suitability for Active Surveillance (HEMI)
- Conditions
- prostate cancerC61Malignant neoplasm of prostate
- Registration Number
- DRKS00005180
- Lead Sponsor
- niversitätsklinikum Regensburg
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Male
- Target Recruitment
- 200
• 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)
- 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
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method o initiation of definitive therapy (radical prostatectomy, radiation, complete HIFU, cryotherapy, hormone therapy) after one year
- Secondary Outcome Measures
Name Time Method