Clinical trial NCT06212453: Evaluation of the Functional Outcomes After Bilateral, 3D Ultrasound-guided Focal Thermal Ablation of the Prostate Transition Zone, in Patients with Benign Prostatic Hyperplasia-related Obstruction
Official title: Evaluation of the Functional Outcomes After Bilateral, 3D Ultrasound-guided Focal Thermal Ablation of the Prostate Transition Zone, in Patients with Benign Prostatic Hyperplasia-related Obstruction
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Benign Prostatic Hyperplasia
Keywords: Benign Prostatic Hyperplasia
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2024-01-18
Enrollment: 22
Sex: MALE
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Targeted Microwave Ablation
Primary purpose: TREATMENT

Brief summary: The aim of the current study is to evaluate the efficacy of transperineal focal microwave ablation (TMA) of the prostate transition zone as a new treatment for lower urinary tract symptoms (LUTS) due to benign prostatic hyperplasia (BPH) within a prospective single-institutional pilot study.

Detailed description: Transurethral resection of the prostate, laser vaporization or enucleation, and simple open prostatectomy represent the current gold standard surgical interventions for BPH-related obstruction. However, these treatments are burdened by their invasiveness, intra and post-operative morbidity, and long-term complications, including ejaculatory dysfunction (70%), urethral strictures (7%), urinary incontinence (2%), and bleeding. Laser-based surgical strategies have only partially overcome these drawbacks.

To provide a personalized therapy for the treatment of BPH related-symptoms, several minimally invasive surgical therapies (MISTs) were developed with the aim of achieving outcomes comparable to the gold standard invasive procedures while minimizing SD and other complications. Urolift implants and Rezum system have demonstrated less complication rate and hospitalization time than standard surgeries.

Recently, 3D ultrasound-guided transperineal focal microwave ablation (TMA) was developed as a focal treatment for localized prostate cancer. Ultrasound-MRI image fusion was performed with organ-based tracking-registration using KOELIS Trinity™ (Koelis, Meylan, France). Microwave thermal ablation was provided by the TATO generator (Biomedical Srl, Firenze, Italy) using a single 17G needle inserted transperineally. This treatment was reported to be safe, precise, and feasible in an outpatient setting.

Eligibility criteria: Inclusion Criteria:

* Man over 40 years old
* Indication of surgical management for BPH
* Prostate volume ≥30 cc and ≤100 cc as evaluated by ultrasonography
* IPSS score ≥15
* Qmax ≤12 ml/s
* Affiliated to the French national social security system
* Patient suitable for IV sedation or general anesthesia and focal microwave ablation
* Wish and able to comply with planned visits
* Able to express his consent
* Signed informed consent form

Exclusion Criteria:

* Unwillingness to accept the treatment
* Neurological pathology responsible for micturition disorders
* History of prostatic surgery
* History of prostatic arterial embolization
* Prostate protrusion Index of grade 2 (\>5 mm) or more as evaluated by ultrasonography.
* Stenosis of the urethra
* History of prostate cancer
* History of radiotherapy or pelvic surgery
* Life expectancy \<2 years
* Inability to understand the informed consent document, to give consent voluntarily or to complete the study tasks.
* Participation in another clinical study involving an investigational product within 1 month before study entry.

Primary outcomes:
measure: Difference between IPSS score at baseline and at 3 months
timeFrame: 3 months
Secondary outcomes:
measure: Length of hospital stay
timeFrame: 1 month
measure: Need for postoperative bladder catheterization
timeFrame: 1 month
measure: Duration of postoperative bladder catheterization
timeFrame: 1 month
measure: Postoperative pain
timeFrame: two hours after surgery
measure: Dimensions of transitional zone tissue ablation
timeFrame: 7 days
measure: Male Sexual Health Questionnaire-ejaculatory dysfunction Short Form (MSHQ-EjD-SF)
timeFrame: 1, 3 and 12 months
measure: International Index of Erectile Function (IIEF-15)
timeFrame: 1, 3 and 12 months
measure: IPSS score
timeFrame: 1, 3 and 12 months
measure: Urinary Symptom Profile (USP)
timeFrame: 1, 3 and 12 months
measure: Qmax
timeFrame: 1, 3 and 12 months
measure: Patients perspectives and treatment preferences
timeFrame: Baseline
Other outcomes:
Locations:
city: Paris
country: France
facility: Hôpital Cochin
Study officials:
affiliation: Assistance Publique - Hôpitaux de Paris
name: Nicolas BARRY DELONGCHAMPS, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Yuan JQ, Mao C, Wong SY, Yang ZY, Fu XH, Dai XY, Tang JL. Comparative Effectiveness and Safety of Monodrug Therapies for Lower Urinary Tract Symptoms Associated With Benign Prostatic Hyperplasia: A Network Meta-analysis. Medicine (Baltimore). 2015 Jul;94(27):e974. doi: 10.1097/MD.0000000000000974.
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citation: Gratzke C, Bachmann A, Descazeaud A, Drake MJ, Madersbacher S, Mamoulakis C, Oelke M, Tikkinen KAO, Gravas S. EAU Guidelines on the Assessment of Non-neurogenic Male Lower Urinary Tract Symptoms including Benign Prostatic Obstruction. Eur Urol. 2015 Jun;67(6):1099-1109. doi: 10.1016/j.eururo.2014.12.038. Epub 2015 Jan 19.
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