Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 1:58 PM
Ignite Modification Date:
2025-12-24 @ 1:58 PM
NCT ID:
NCT06223295
Eligibility Criteria:
Inclusion Criteria:
* 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
Exclusion Criteria:
* Unfit for general anesthesia or radical surgery
* Low volume low-risk disease (≤4mm Gleason 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 MRCT.
* 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
Healthy Volunteers:
False
Sex:
MALE
Minimum Age:
45 Years
Study:
NCT06223295
Study Brief:
Protocol Section:
NCT06223295