Effectiveness of focal therapy in men with prostate cancer (ENFORCE) - ENFORCE

Radboud Universitair Medisch Centrum0 个研究点目标入组 356 人开始时间: 待定最近更新: 2024年4月9日

适应症

试验速览

暂无简介。

•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

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