Laser Ablation for Benign Prostatic Hyperplasia

Overseen By Eusebio J Luna, MD

Age: 18+

Sex: Male

Trial Phase: Phase 1

Sponsor: Urological Research Network, LLC

Must be taking: Alpha-1 adrenergic

Disqualifiers: Prostate cancer, Bladder cancer, Neurological conditions, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 5

Duration: 1 day

20 Participants Needed

Trial Summary

What is the purpose of this trial?

This study is set up as a phase I-II prospective, single center, interventional pilot study carried in Office setting under local anesthesia. It will assess the impact in quality of life and adverse events produced by transperineal laser ablation of the prostate (TPLA) in men 40 to 85 years of age with benign prostatic hypertrophy (BPH). BPH is currently managed with medications (ie, alpha-1 adrenergic medications) and/or invasive approaches such as transurethral resection of prostate or surgical excision of prostate - robotic or open lead to relaxation or excision of the bladder neck. Such alteration of the bladder neck function or anatomy portends a significant and noticeable change on a male lifestyle, represented by absence of antegrade ejaculation among others. This study aims to evaluate the use of TPLA in the office setting under local anesthesia - greatly decreasing patient perioperative surgical risk. Moreover, it aims to determine safety profile and outcomes from TPLA therapy The fundamental objective is to determine the feasibility and safety of TPLA in healthy men with LUTS due to BPH, successful performed in the outpatient office-based setting under local anesthesia. Secondary objectives include: 1-Uroflowmetry and Patient Reported Outcome Measures (PROMs) at three, six and 12 months; 2-Immediately spontaneous voiding post-TPLA; 3-Hematuria incidence after TPLA, measured by patient reporting; 4-LUTS after the treatment measured by IPSS; 5- Erectile function and presence of ejaculation after TPLA treatment and 6-Prostate volume changes using Transrectal ultrasound (TRUS) volume measurements

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but it mentions that you must be able to temporarily stop anticoagulation or anti-platelet therapy. It's best to discuss your specific medications with the trial team.

What data supports the effectiveness of the treatment SoracteLite(TM) TPLA for BPH?

Research shows that SoracteLite™ transperineal laser ablation (TPLA) is a promising minimally invasive treatment for benign prostatic hyperplasia (BPH), with studies indicating its effectiveness and safety at 6 and 12 months follow-up. It is designed to be performed under local anesthesia, reducing the need for more invasive procedures and their associated complications. ^{1 2 3 4 5}

How is the SoracteLite TPLA treatment for benign prostatic hyperplasia different from other treatments?

SoracteLite TPLA is unique because it uses a transperineal (through the skin between the anus and scrotum) laser approach, allowing it to be performed under local anesthesia in an outpatient setting, unlike traditional surgeries that require general or spinal anesthesia. It uses a 1064-nm diode laser to induce coagulative necrosis (tissue death), and the system can independently control four laser sources, making it a minimally invasive option with potentially fewer complications. ^{2 3 4 5 6}

Research Team

FERNANDO J BIANCO, MD

Principal Investigator

Urlogical Research Network

Eligibility Criteria

Men aged 40-85 with benign prostatic hyperplasia (BPH) can join this trial. They must have certain urinary flow rates, a prostate size within specific limits, and moderate to severe lower urinary tract symptoms but no history of invasive prostate interventions or major neurological conditions. Participants need normal kidney function and the ability to stop blood thinners temporarily.

Inclusion Criteria

Post-void residual (PVR): ≤ 250 mL

My prostate size is between 30 and 120 cc.

I have moderate to severe urinary symptoms.

Exclusion Criteria

Indwelling Foley catheter or clean intermittent catheterization (CIC) in the prior 30 days

I do not have major neurological conditions like Alzheimer's or Parkinson's.

I have had prostate or bladder cancer in the past.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo SoracteLiteTM transperineal laser ablation (TPLA) for benign prostatic hyperplasia (BPH) under local anesthesia

1 day

1 visit (in-person)

Immediate Follow-up

Participants are monitored for immediate adverse events and recovery post-procedure

1 week

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessments at 3, 6, and 12 months

12 months

3 visits (in-person or virtual)

Long-term Follow-up

Participants are monitored for long-term outcomes and potential re-treatment or conversion to other surgical management

5 years

Annual visits (in-person or virtual)

Treatment Details

Interventions

• SoracteLite(TM) TPLA for BPH

Trial Overview The study is testing SoracteLite(TM) TPLA for BPH in an office setting under local anesthesia. It aims to improve quality of life by reducing risks associated with traditional surgical treatments for BPH while preserving sexual functions like ejaculation.

Participant Groups

Group I: Transperineal Laser Ablation for BPH Experimental Treatment 1 Intervention

Ceftriaxone 250 mg IM as antibiotic prophylaxis. Local Anesthesia: perineal skin will be infiltrated with 10 cc of Lidocaine 2% and then each neurovascular bundle will be infiltrated with 5 - 10 cc. Nitrous self-administered anesthesia will be available. One or two laser fibers from Echolaser x4 will be placed in each of the two prostate lobes using the plan. Treatment will be executed following Echolaser smart Interface planning, needles will follow targeted location using stepper grid under a transperineal approach in a sagittal plane. Ablation with 5 watts power per fiber, a total of \~ 1800 J will be delivered. We will evaluate pain measures and procedure tolerance using visual analog pain scale Upon completion we will measure coagulation zone with TRUS. Before discharge, trial of void will be conducted. Patients with a residual greater than 200 cc will have an indwelling catheter placed and will be discharged with it.

Who Is Running the Clinical Trial?

Urological Research Network, LLC

Lead Sponsor

Trials

5

Recruited

10,200+

References

1. United States pubmed.ncbi.nlm.nih.gov

Transperineal Laser Ablation for Percutaneous Treatment of Benign Prostatic Hyperplasia: A Feasibility Study. [2018]

2. England pubmed.ncbi.nlm.nih.gov

Transperineal laser ablation for percutaneous treatment of benign prostatic hyperplasia: a feasibility study. Results at 6 and 12 months from a retrospective multi-centric study. [2021]

3. Netherlands pubmed.ncbi.nlm.nih.gov

Safety and Feasibility of Soractelite Transperineal Focal Laser Ablation for Prostate Cancer and Short-term Quality of Life Analysis from a Multicenter Pilot Study. [2022]

4. Canada pubmed.ncbi.nlm.nih.gov

Transperineal Laser Ablation Treatment for Lower Urinary Tract Symptoms Due to Benign Prostatic Obstruction: Protocol for a Prospective In Vivo Pilot Study. [2020]

5. England pubmed.ncbi.nlm.nih.gov

Transperineal laser ablation as a new minimally invasive surgical therapy for benign prostatic hyperplasia: a systematic review of existing literature. [2023]

6. England pubmed.ncbi.nlm.nih.gov

3-T MRI and clinical validation of ultrasound-guided transperineal laser ablation of benign prostatic hyperplasia. [2022]