Clinical trial NCT06601179: Evaluating the Safety and Efficacy of the "HIFU" High-intensity Focused Ultrasound Treatment of Benign Prostatic Hyperplasia;
Official title: Phase 1-2 Dose-escalation Study, Evaluating the Safety and Efficacy of the "HIFU" High-intensity Focused Ultrasound Treatment of Benign Prostatic Hyperplasia After 3 Months, 6 Months, 12 Months, 18 Months and 36 Months.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Benign Prostatic Hyperplasia
Lead sponsor: EDAP TMS S.A.
Sponsor class: INDUSTRY
First posted: 2024-09-19
Enrollment: 100
Sex: MALE
Minimum age (years): 50
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Phase 1 aims to determine the minimum effective dose for BPH treatment. It will include 10 patients receiving 50% of the standard shooting power. If, after a 3-month follow-up, there are no serious adverse events (SAEs) and good efficacy, Phase 2 will begin.

If Phase 1 results indicate that 50% power is insufficient, power levels will be increased by 10% increments (60%, 70%, 80%, 90%) with similar follow-up until the minimum effective dose is determined.

Phase 2 aims to validate the effocacy of the minimum effective dose. It will include 90 new patients treated with the same 50% power. They will be monitored regularly after 1 and 3 months, every 6 months up to 24 months, and finally at 36 months.
Primary purpose: TREATMENT

Brief summary: Prostate adenoma, also known as benign prostatic hypertrophy or hyperplasia (BPH), involves an increase in the size of the prostate, forming a benign tumor. It is the most common benign tumor in men, generally affecting those over 40 years old. The risk of BPH is more than 50% in men aged 50 to 60 and rises to 90% in men by age 80.

This hyperplasia leads to altered urinary flow and bladder outlet obstruction, referred to as "lower urinary tract symptoms" or LUTS, which become more frequent with age. These symptoms are categorized as obstructive or irritative. In the early stages, men with BPH may have difficulty starting urination and may feel as if their bladder is not completely empty. As a result, they need to urinate more often, especially at night, a condition known as nocturia. Additionally, the volume and velocity of the urinary flow may decrease significantly, as evidenced by flow measurements, and residual urine discharge may occur at the end of urination.

High-intensity focused ultrasound (HIFU) is a medical technique that uses high-intensity ultrasonic waves to treat various medical conditions, including malignant and benign tumors, without the need for invasive surgery or ionizing radiation. HIFU generates heat between 80° to 95°C at the focal point, causing necrosis of the targeted area with pinpoint accuracy. In urology, HIFU is used to treat prostate cancer in a minimally invasive manner, with focused ultrasounds delivered endorectally using a transducer that targets the treatment area with real-time monitoring.

Exclusively targeted HIFU treatment has been suggested for BPH, where localized necrosis of the side lobes reduces the volume of the prostatic transition zone, alleviating compression of the prostatic urethra and improving urinary symptoms.

This new study was initiated to evaluate the safety and efficacy of HIFU for BPH treatment.


Eligibility criteria: Inclusion Criteria:

Men aged ≥ 50 to ≤ 85

Patient diagnosed with benign prostatic hyperplasia evaluated by:

* Prostate volume ranging from 30 cc to 80 cc evaluated by MRI
* Qmax \< 15ml/s
* IPSS ≥ 8
* IPSS-QoL ≥ 3
* IIEF-5 \> 17

Patient for whom medical treatment failed (having been taken regularly for more than 12 weeks) OR patient with a contraindication to the initiation of medical treatment OR patient refusing medical treatment Patient whose prostate show no sign of cancerous lesion confirmed by MRI Patient capable of reading and understanding French or with a carer who speaks French and could help the patient understand the leaflet and the questionnaires Patient registered with a social security scheme Patient having given their free and informed consent to participate in the study

Exclusion Criteria:

Presence of a median lobe preventing the HIFU treatment to be delivered according to the investigator's judgment Prostate cancer confirmed or suspected History of surgical treatment of the prostate History of radiotherapy of the prostate History of bladder cancer History of urethral stricture Presence of a urinary tract fistula Urethral stricture or untreated bladder neck stenosis Untreated urinary lithiasis Neurological bladder or neurological bladder disease or any other neurological disease likely to affect the functioning of the bladder-sphincter system History of pelvic radiotherapy Patient with renal failure with GFR \< 35ml/min Patient currently undergoing anticoagulant therapy (antivitamins K (AVK) and new oral anticoagulants (NOACs) for which the stop window cannot exceed 48H at the time of the HIFU procedure Contraindication to the surgical procedure, in particular anesthesia Contraindication to the pelvic MRI Patient with a rectal wall \> 10mm

Contraindication to the HIFU treatment procedure:

* Active urogenital infection (the infection must be treated before HIFU treatment)
* Anal or rectal fibrosis, anal or rectal stenosis or any other abnormalities making it difficult to insert the Focal One® probe
* Urinary tract or rectal fistula
* Anatomic abnormalities of the rectum or rectal mucosa
* Presence of permanent radioactive implants in the rectal wall
* Presence of prostatic calcification the location of which interferes with the HIFU treatment
* Patient with an artificial sphincter, a penile prosthesis or intra-prostatic implant; for example, an endoprosthesis
* Presence of an implant (stent, catheter) within 1cm of the treatment area
* History of inflammatory bowel disease
* Presence of metal stents or implants in the urethra Patient refusing to participate in the study Person under guardianship considered legally incapable of giving their informed consentPatient unable or refusing to complete the questionnaires Persons placed under judicial protection Subject participating in another study including an exclusion period that is still running at the time of pre-inclusion

Primary outcomes:
measure: Rate of adverse events
timeFrame: 3 months
measure: Rate of patients with two of the following criteria ( Δ Qmax ≥ 50%, Δ IPSS ≥30%, Homogeneous necrosis observed on MRI)
timeFrame: 3 months
measure: Rate of patients that meet the four evaluation criteria (Absence of AD Clavien-Dindo ≥ III + ΔQmax ≥ 50% + Δ IPSS ≥30% + IPSS-QoL score ≤2)
timeFrame: 6 months
Secondary outcomes:
measure: Rate of adverse events
timeFrame: 36 months
measure: Rate of patients with a significant decrease of prostate size
timeFrame: 36 months
measure: The impact of the HIFU treatment on the urinary flow
timeFrame: 36 months
measure: Rate of patients with a significant decrease of RPM
timeFrame: 36 months
measure: The rate of patients with a significant improvment of obstructive and irritative symptoms of the lower urinary tract
timeFrame: 36 months
measure: The rate of patients with a significant improvment of LUTS-related quality of life
timeFrame: 36 months
measure: The rate of patients with an improvment in the erectile function
timeFrame: 36 months
measure: The evaluation of the impact of treatment on the ejaculatory function
timeFrame: 36 months
measure: The rate of patients with a recurrence over the follow-up period up to 36 months
timeFrame: 36 months
measure: The cost related to the use of HIFU
timeFrame: 36 months
measure: Efficiency
timeFrame: 36 months
Other outcomes:
Locations:
city: Besançon
country: France
facility: Clinique Saint Vincent
city: Bordeaux
country: France
facility: Clinique Tivoli-Ducos
city: Bordeaux
country: France
facility: Groupe Hospitalier Pellegrin
city: Lille
country: France
facility: CHU de Lille
city: Lyon
country: France
facility: HCL_Hôpital Edouard Herriot
city: Martigues
country: France
facility: CH Matigues
city: Suresnes
country: France
facility: Hôpital Foch
city: Toulon
country: France
facility: Clinique Saint Michel
city: Toulouse
country: France
facility: Hôpitaux de Toulouse
Study officials:
References: