Effectiveness of focal therapy in men with prostate cancer (ENFORCE)
- Conditions
- Prostate carcinomaprostate carcinoma100385971003695810025506
- Registration Number
- NL-OMON55975
- Lead Sponsor
- Radboud Universitair Medisch Centrum
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 356
Men with unilateral clinically significant intermediate-risk PCa ór dominant
unilateral clinically significant intermediate-risk and small contralateral
low-risk (ISUP 1) disease:
• Gleason score of 7 (3 + 4 or 4 + 3; ISUP grade 2/3)
• PSA level of <= 20 ng/ml
• Clinical stage <= T2b disease
• Life expectancy of >= 10 years
• Men with a prostate size <= 5 cm in sagittal length and <= 6 cm in axial length
• Fit, eligible, and normally destined for radical surgery or radiotherapy
• No concomitant cancer
• No previous treatment of their prostate
• An understanding of the Dutch language sufficient to receive written and
verbal information about the trial, its consent process and the study
questionnaires
A potential subject who meets any of the following criteria will be excluded
from participation in this study: • Unfit for general anesthesia or radical
surgery • Low volume low-risk disease (<=4mmGleason score of <= 6 / ISUP grade 1)
• High-risk disease (Gleason score of >= 8 / ISUP grade >3) • Clinical T3
disease (extracapsular PCa) • Men who have received previous active therapy for
PCa. • Men with evidence of extraprostatic disease. • Men with an inability to
tolerate a transrectal ultrasound. • Cardiac pacemaker • Metal implants/stents
in the urethra or prostate. • ASA >=4 • Prostatic calcification/cysts that
interfere with effective delivery of TULSA/HIFU based on CT. • Men with renal
impairment and a glomerular filtration rate (GFR) of < 30 ml/minute/1.73 m2. •
Unable to give consent to participate in the trial, as judged by the attending
clinicians
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method