Focal Laser Ablation for Benign Prostatic Hyperplasia

August 1, 2019 updated by: Guglielmo Manenti, University of Rome Tor Vergata

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

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Italy
    • RM
      • Rome, RM, Italy, 00133
        • Recruiting
        • Policlinico Tor Vergata (PTV) Foundation: UOC Department of Diagnostic Imaging and Interventional Radiology
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

47 years to 81 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: ECHOLASER X4 Socratelite
Optic fiber of 300um will be inserted at a distance of 8-10mm from the urethra. Each ablation lasts 6 minutes. Each fiber ablates at an energy of 1800J with a power of 2-3W. Treatment lasts for about 30 minutes.
Procedure: Transperineal Focal Laser Ablation (TPLA)
The intervention will take place in an ambulatory setting of the interventional radiology department using the combined Echolaser XVG system. The treatment consists of a local anesthesia to the perineal region. Within each needle, an optic fiber of 300um will be inserted. Each ablation lasts 6 minutes and each fiber ablates1800J at a power of 2-3W. At the end of the ablation there is a pull-back of about 1cm from the original ablation location. According to the dimension of the middle lobe of the prostate, multiple pullbacks can be used. The total ablation is 3600J for 2 fibers (1800J/ fiber) at the power of 2-3W for a total duration of about 30minutes. At the end of the treatment, a 20mg bolus of i.v. corticosteroid is given for anti-edema and anti-inflammatory effects. Antibiotic therapy (Ciprofloxacin 500mg and gastroprotective therapy is given for 5 days. After an adequate amount of time for observation, the patient is dismissed.
Other Names:
  • Focal Laser Ablation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical symptoms at 1-yr follow-up evaluated with usual objective and subjective parameters
Time Frame: 12 months
Improvement of obstructive symptomatology correlated to BPH. The evaluation will be based on urodynamic studies of Qmax, post void and residual volume.
12 months
Rate of complication needing re-hospitalisation or reintervention
Time Frame: procedure date to 12 months
Evaluation of complications post TPLA treatment by MRI.
procedure date to 12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Reproducibility of Multi-parametric MRI
Time Frame: 12 months.
Evaluation of multi-parametric MRI of the prostate to quantify and/or preview coagulative necrosis after treatment and evaluate the response to transperineal laser ablation treatment for lower urinary tract symptoms.
12 months.
Total and post-operative costs during follow-up compared to transurethral resection of the prostate
Time Frame: 12 months
Calculation and stratification of prodecural costs in in comparison to transurethral resection of the prostate (TURP).
12 months
Evaluation of Quality of Life by International Prostate Symptom Score
Time Frame: 12 months
Evaluation of quality of life quantified by the questionnaire (IPSS)
12 months
Evaluation of Quality of Life by International Index of Erectile Function
Time Frame: 12 months
Evaluation of Quality of Life by International Index of Erectile Function (IIEF)
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Rome Tor Vergata

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 5, 2018

Primary Completion (Anticipated)

April 5, 2023

Study Completion (Anticipated)

April 5, 2023

Study Registration Dates

First Submitted

July 11, 2019

First Submitted That Met QC Criteria

August 1, 2019

First Posted (Actual)

August 5, 2019

Study Record Updates

Last Update Posted (Actual)

August 5, 2019

Last Update Submitted That Met QC Criteria

August 1, 2019

Last Verified

August 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • R.S.71.18

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

Create an international registry to assess long-term effectiveness of transperineal laser ablation for lower urinary tract symptoms, to assess functional outcomes, to assess safety, to determine baseline patient characteristics, to collect information on possible differences between centres applying treatment of transperineal laser ablation and to explore the optimal treatment indications and possible limitations. It an international prospective observational registry in which data is recorded of patients who are treated with transperineal laser ablation for lower urinary tract symptoms.

IPD Sharing Time Frame

This registry will be open for inclusion for five years. Since individual patients will have a follow-up of five years, the total study duration will be 10 years.

IPD Sharing Access Criteria

Every accredited centre that performs TPLA procedures, wants to participate and signs the regulatory document and obtains ethical committee approval can participate

IPD Sharing Supporting Information Type

  • Study Protocol
  • Informed Consent Form (ICF)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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