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 @ 11:50 PM
Ignite Modification Date:
2025-12-24 @ 11:50 PM
NCT ID:
NCT03845751
Eligibility Criteria:
Inclusion Criteria:
* Men aged 40 and over.
* Life expectancy ≥ 10 years.
* Localized, intermediate-risk PCa (according to the most recent version of the European Association of Urology Prostate Cancer Guidelines).
* PI-RADS ≥ 3 lesions in MRI (PI-RADS v2.1).
* Unilateral (unifocal or multifocal) PCa or bilateral disease allowing unilateral GS 3+3 up to 1mm in the non-treated side.
* Histopathologically verified PCa by any mpMRI-targeted prostate biopsy (3 cores per each target lesion + 12 random cores performed).
* Any Gleason score 7 (3 + 4) (ISUP2).
* Prostate specific antigen (PSA) ≤15 ng/ml.
* Clinical stage T1c-T2b (based on MRI and/or rectal examination).
* Absence of lymph node and distant metastases.
* Prostate volume ≤ 60 ml. Patient with prostate volume between 40 ml and 60 ml could be included only if lesion is located in posterior zone of the prostate.
* Treatment-naive patients (received no previous treatments for PCa, apart from active surveillance).
* World Health Organization (WHO) performance status of grade 0-2.
* Men who are sexually active with women of chidbearing potential must use a highly effective method of contraception prior the first administration of hormonal therapy and must agree to continue using such precautions for 130 days after the final administration of the treatment.
* Having signed a written informed consent form.
Exclusion Criteria:
* Men under the age of 40.
* Life expectancy less than 10 years.
* Any Gleason score ≤6 (3 + 3) (ISUP1).
* Any Gleason score≥ 7 (4+3) (ISUP3).
* PI-RADS \< 3 lesions in MRI (PI-RADS v2.1).
* Apex lesions may ≥ 10 mm away from the urethral sphincter.
* PSA \>15 ng/ml.
* Clinical stage \> cT2b (based on MRI and rectal examination).
* Evidence of extra-prostatic extension or seminal vesicle invasion.
* Evidence of lymph node or distant metastases.
* Prostate volume \> 40 ml when lesion is located in the anterior zone of the prostate.
* Prostatic calcifications or cysts whose location may interfere with effective delivery of HIFU energy.
* Metal implants/stents in the urethra.
* Active urinary tract infection.
* Men who have previously received any form of PCa treatment (e.g. external beam radiation therapy (EBRT), brachytherapy, HIFU, cryosurgery, thermal or microwave therapy and/or hormonal therapy).
* Patient treated with 5 α-reductase inhibitors in the previous 3 months and during the study.
* Men who have undergone surgery for benign prostatic hyperplasia in the previous 6 months; i.e. a transurethral resection of the prostate (TURP), holmium laser enucleation (HOLEP), greenlight laser vaporization, others.
* Men with an inability to tolerate a transrectal ultrasound probe or have undergone prior significant rectal surgery preventing insertion of transrectal HIFU probe.
* Men unable to have MRI scanning (e.g. men with severe claustrophobia, permanent cardiac pacemaker or metallic implant which may likely contribute to significant image artefacts).
* Men with renal impairment and a glomerular filtration rate (GFR) of \<35 ml/min (unable to tolerate Gadolinium dynamic contrast enhanced MRI).
* WHO performance status of grade 3-4 / men unfit for surgery.
* Hypersensitivity to leuprorelin acetate, to other GnRH agonists or to any of the excipients.
* Men with congenital long QT syndrome, congestive heart failure, frequent electrolyte abnormalities, or taking drugs known to prolong the QT interval.
* Patients who previously underwent orchidectomy.
* Language barriers that might hinder the communications, understanding of written and verbal information about the trial, consenting process, or completing the questionnaires.
* Men refusing to sign an informed consent to participate in the trial.
* Men with relative and/or absolute contraindications to androgen deprivation therapy.
Healthy Volunteers:
False
Sex:
MALE
Minimum Age:
40 Years
Maximum Age:
80 Years
Study:
NCT03845751
Study Brief:
Protocol Section:
NCT03845751