Evaluating the Safety and Efficacy of the "HIFU" High-intensity Focused Ultrasound Treatment of Benign Prostatic Hyperplasia;

NCT06601179 | Recruiting DMC

• 1 other identifier: HIFU.F.23.02
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 9

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.

Conditions

Benign Prostatic Hyperplasia

Outcome Measures

Primary Outcomes (3)

• Rate of adverse events

  Phase 1 Presence of significant cavitation that may be associated with adverse effects. Repeated urethral involvement that could damage the urethra. Absence of serious adverse effects (Clavien-Dindo ≥ III) directly attributable to the HIFU treatment procedure at 3 months of follow-up. Based on these elements, the scientific committee will analyze the cause-and-effect relationship between the indicators observed during treatment and the adverse effects.

  3 months

• Rate of patients with two of the following criteria ( Δ Qmax ≥ 50%, Δ IPSS ≥30%, Homogeneous necrosis observed on MRI)

  Phase 1 Efficacy : Efficacy will be considered satisfactory if at least two of the following three conditions are met: Significant improvement in the maximum flow defined by Δ Qmax ≥ 50% of the initial flow or by a removal of the urinary catheter or supra-pubic catheter in included patients with urinary retention. Improvement in obstructive and irritative symptoms 3 months after treatment, defined by a reduction in the IPSS score defined by Δ IPSS ≥30% Homogeneous necrosis observed on MRI

  3 months

• Rate of patients that meet the four evaluation criteria (Absence of AD Clavien-Dindo ≥ III + ΔQmax ≥ 50% + Δ IPSS ≥30% + IPSS-QoL score ≤2)

  Phase 2 Efficacy of the treatment To validate phase 2, 80% of patients are expected to meet the four evaluation criteria below after 6 months. Evaluation of urinary symptoms, continence, the erectile function, postoperative complications using a composite "tetrafecta" score defined by 4 criteria: 1. Absence of serious adverse effects relating to the HIFU procedure, Clavien-Dindo ≥ III after 6 months. 2. Significant improvement in the maximum flow defined by ΔQmax ≥ 50% of the initial flow after 6 months, or by a removal of the urinary catheter after 3 months in included patients with urinary retention. 3. Improvement in obstructive and irritative symptoms 6 months after treatment, defined by a reduction in the IPSS score defined by Δ IPSS ≥30% 4. Improvement in quality of life 6 months after treatment defined by an IPSS-QoL score ≤2

  6 months

Secondary Outcomes (11)

• Rate of adverse events

  36 months

• Rate of patients with a significant decrease of prostate size

  36 months

• The impact of the HIFU treatment on the urinary flow

  36 months

• Rate of patients with a significant decrease of RPM

  36 months

• The rate of patients with a significant improvment of obstructive and irritative symptoms of the lower urinary tract

  36 months

Study Arms (1)

HIFU

EXPERIMENTAL

Device: HIFU

Interventions

HIFU DEVICE

high-intensity focused ultrasound treatment of benign prostatic hyperplasia

HIFU

Eligibility Criteria

• Age: 50 Years - 85 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• EDAP TMS S.A.: lead

Study Sites (9)

Clinique Saint Vincent

Besançon, 25000, France

NOT YET RECRUITING

Clinique Tivoli-Ducos

Bordeaux, 33000, France

NOT YET RECRUITING

Groupe Hospitalier Pellegrin

Bordeaux, 33000, France

NOT YET RECRUITING

CHU de Lille

Lille, 59000, France

NOT YET RECRUITING

HCL_Hôpital Edouard Herriot

Lyon, 69003, France

RECRUITING

CH Matigues

Martigues, 13500, France

RECRUITING

Hôpital Foch

Suresnes, 92150, France

NOT YET RECRUITING

Clinique Saint Michel

Toulon, 83100, France

NOT YET RECRUITING

Hôpitaux de Toulouse

Toulouse, 31400, France

NOT YET RECRUITING

MeSH Terms

Conditions

Prostatic Hyperplasia

Condition Hierarchy (Ancestors)

Prostatic Diseases; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Male Urogenital Diseases

Central Study Contacts

Djamila BENNAT

CONTACT

33472153142; affaires-cliniques@edap-tms.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: July 8, 2024
• First Posted: September 19, 2024
• Study Start: August 23, 2024
• Primary Completion (Estimated): August 31, 2028
• Study Completion (Estimated): August 31, 2028
• Last Updated: October 15, 2024

Record last verified: 2024-10

Locations

FR (9)