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.
