NL-OMON55975
Recruiting
Phase 3
Effectiveness of focal therapy in men with prostate cancer (ENFORCE) - ENFORCE
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Prostate carcinoma
- Sponsor
- Radboud Universitair Medisch Centrum
- Enrollment
- 356
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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
Exclusion Criteria
- •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\. •
Outcomes
Primary Outcomes
Not specified
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