Clinical trial NCT04044573: Focal Laser Ablation for Benign Prostatic Hyperplasia
Official title: Efficacy of Ultrasound Guided Percutaneous Transperineal Laser Ablation in Benign Prostatic Hypertrophy Patients: Non-Pharmacological Interventional Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Benign Prostatic Hyperplasia
Lower Urinary Tract Symptoms
Keywords: BPH
mpMRI
interventional radiology
Lead sponsor: University of Rome Tor Vergata
Sponsor class: OTHER
First posted: 2019-08-05
Enrollment: 40
Sex: MALE
Minimum age (years): 51
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Efficacy of Ultrasound Guided Percutaneous Transperineal Laser Ablation in Benign Prostatic Hypertrophy Patients: Non-Pharmacological Interventional Study

Detailed description: Efficacy of Ultrasound Guided Percutaneous Transperineal Laser Ablation in Benign Prostatic Hypertrophy Patients: Non-Pharmacological Interventional Study

The aim of this pilot study is to evaluate the efficacy of TPLA under US-guidance and the safety and the reproducibility in acute and follow-up.

Objective of the study: Evaluate the efficacy of percutaneous ablative treatment with neodymium laser; the complete profile of safety and tolerability in acute and in the follow-up in patients with Benign Prostatic Hypertrophy by using multiparametric prostate MRI that allows us to evaluate the prostate acutely after treatment and in follow-up. All of the imaging data is correlated with clinical and laboratory data.

Design of the study: Non-pharmacological interventional study. The clinical evaluation will be carried out at three different times:

Time 1: eligibility assessment, signing of informed consent Time 2: admission, laser ablation and control with multiparametric MRI of the post-procedural prostate (T0).

Time 3 Follow up at 3 (T1) -6 (T2) -12 (T3) months from the procedure.

There are various inclusion and exclusion criteria. The inclusion criteria are: over 65 years old, benign prostate hypertrophy (BPH) confirmed by pre-interventional multi-parametric (mpMRI), moderate-elevated surgical risk, presence of urinary obstructive symptoms, signed consent form. Exclusion criteria are: presence of prostate tumor diagnosed by MRI and confirmed by biopsy, urethral stenosis, severe coagulation pathology, ischemic pathology, pacemaker presence, inflammatory pathology in acute phase, presence of 3rd dominant lobe and contraindication to MRI.

Pre-treatment blood chemistry tests:

* Total and fractionated PSA
* Complete blood count with platelet count and leukocyte formula
* Blood coagulation tests
* Urine test - urine culture
* Azotemia
* Creatinine

Technique of performing a percutaneous laser ablation treatment:

The treatments are performed by the radiology team, in an outpatient setting using the Echolaser XVG combined system.

The procedure is performed with the patient in gynecological position, and in safe conditions according to the current legislation for laser treatments (such as protective glasses).

Treatment includes local anesthesia of the perineal region, under ultrasound guidance. At the discretion of the medical team, sedation can be carried out with anesthetic assistance.

2 or 4 needles of 21G, 1 or 2 will be inserted. In each needle a 300 micron optical fiber will be inserted - Elesta s.r.l. - 50041, Calenzano (FI) - Italy, at a distance of 8-10 mm from the urethra. For each ablation, for about 6 minutes, an energy of 1200 J per fiber will be delivered, at the power of 2-5 Watts. At the end the needle and the fiber is retracted for about 1 cm ("pull-back"). Further ablation follows, with delivery and duration and power equal to the previous one. Depending on the size of the middle lobe one or more pull-backs can be made. In total the treatment consists in dispensing up to 1800 J, at the power of 2-5 W for a total duration of 30 minutes.

The laser causes hyperthermia, denaturation and coagulative necrosis of proteins.

The maximum volume treated in a session and the extent of the ablation vary according to the prostatic volume, anatomy and receptivity of the tissue.

At the end of the treatment 20 mg of corticosteroids ev (if not specifically contraindicated by the patient) is administered, for anti-edema and anti-inflammatory purposes. An antibiotic, pain relief and gastroprotective therapy is established for 1 week. After an adequate observation period, the patient will be discharged.

Follow up: The clinical evaluation is carried out at different times

Post procedural follow up:

Immediately after the procedure, a multiparametric prostate MRI is performed, followed by discharge with steroid therapy (prednisone), if not contraindicated, to be scaled and for programming the subsequent follow-up phases.

Post-discharge follow-up:

Specialist examination, suprapubic ultrasound of the urinary tract (with evaluation of the post-residual volume) and multiparametric prostate MRI at 3 months, 6 months and 12 months and subsequent checks according to clinical judgment.

A urine test and any urine culture are attached to each clinical-ultrasound evaluation. At each revaluation the IPSS form and the data collection form is filled out.

Eligibility criteria: Inclusion Criteria:

* Over 50 years old
* BPH confirmed by mpMRI
* Uroflowmetry indicating obstructive pathology
* Surgical risk moderate-elevated
* Symptomatology of obstructive pathology (voiding hesitation, intermittent mitt, urinary flow reduction, incomplete emptying of the bladder, post-urination incontinence and irritative symptoms such as urinary frequency, dysuria, nocturia - quantified with IPSS)
* Signature of the information sheet and of the informed consent to the treatment, at the execution of the multiparametric MRI and the administration of the paramagnetic contrast medium.

Exclusion Criteria:

* MRI signs of malignancy confirmed by biopsy investigation
* Urethral stenosis
* Serious coagulation disorders
* Inadequate compliance
* Ischemic pathology in the previous six months
* Presence of pacemakers
* Active phase inflammatory pathology
* Presence of III dominant prostate lobe
* Contraindications to the execution of MRI (claustrophobia, auricular implants, metal prostheses and other contraindications included in the specific informed consent)
* Paramagnetic contrast medium allergy.
* Acute and / or chronic renal failure (GFR \<50 mL / min and serum creatinine\> 1.5 mg / d)
* Not adequate understanding of the information sheet

Primary outcomes:
measure: Clinical symptoms at 1-yr follow-up evaluated with usual objective and subjective parameters
timeFrame: 12 months
measure: Rate of complication needing re-hospitalisation or reintervention
timeFrame: procedure date to 12 months
Secondary outcomes:
measure: Reproducibility of Multi-parametric MRI
timeFrame: 12 months.
measure: Total and post-operative costs during follow-up compared to transurethral resection of the prostate
timeFrame: 12 months
measure: Evaluation of Quality of Life by International Prostate Symptom Score
timeFrame: 12 months
measure: Evaluation of Quality of Life by International Index of Erectile Function
timeFrame: 12 months
Other outcomes:
Locations:
city: Rome
country: Italy
facility: Policlinico Tor Vergata (PTV) Foundation: UOC Department of Diagnostic Imaging and Interventional Radiology
state: RM
Study officials:
References:
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