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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new laser treatment, SoracteLite(TM) TPLA, for men with benign prostatic hyperplasia (BPH), a condition causing urinary problems. The goal is to determine if using a laser under local anesthesia can improve symptoms and quality of life without more invasive surgery. The study will assess any side effects and the treatment's effectiveness in a simple office setting. Men with noticeable urinary issues due to BPH who have not had previous prostate interventions might be suitable for this trial. As a Phase 1 trial, this research aims to understand how the treatment works in people, offering participants the chance to be among the first to receive this innovative therapy.

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 prior data suggests that this laser ablation technique is safe for treating benign prostatic hyperplasia?

Research has shown that transperineal laser ablation (TPLA) is generally well-tolerated for treating an enlarged prostate, also known as benign prostatic hyperplasia (BPH). Studies indicate that TPLA improves symptoms at both 3 and 12 months after treatment. It is considered a safe and less invasive option for men with urinary problems caused by BPH.

Patients have reported positive results and few side effects, making it a promising alternative to more invasive surgeries. One study confirmed that TPLA is safe and practical when performed in an outpatient setting. Overall, the evidence suggests that TPLA is a reliable choice for managing BPH symptoms with a good safety record. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike the standard treatments for Benign Prostatic Hyperplasia (BPH), which often include medications like alpha-blockers and 5-alpha reductase inhibitors or surgical procedures, SoracteLite(TM) TPLA offers a minimally invasive approach using transperineal laser ablation. This technique targets the enlarged prostate tissue with precision, using laser fibers guided by advanced imaging, potentially reducing side effects and recovery time compared to traditional surgeries. Researchers are excited about this treatment because it could provide effective relief with a lower risk of complications, allowing patients to return to their daily lives more quickly.

What evidence suggests that transperineal laser ablation is effective for benign prostatic hyperplasia?

Research has shown that transperineal laser ablation (TPLA), the treatment under study in this trial, offers a promising approach for managing an enlarged prostate, also known as benign prostatic hyperplasia (BPH). One study found that patients experienced a significant reduction in symptoms, with symptom scores dropping from 20.8 to 8.4, indicating fewer symptoms and improved quality of life. Another study discovered that TPLA improved urine flow and reduced prostate size over a year. Additionally, TPLA has effectively treated both BPH and localized prostate cancer while preserving good sexual function. Overall, TPLA appears to be a safe and effective way to manage BPH symptoms. ^{1 2 3 5 6}

Who Is on the Research Team?

FERNANDO J BIANCO, MD

Principal Investigator

Urlogical Research Network

Are You a Good Fit for This Trial?

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 for a Trial Participant

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)

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10160153/

Ultrasound-guided SoracteLite™ transperineal laser ... At 12-month follow-up, IPSS was significantly improved from 20.8 ± 7.4 to 8.4 ± 5.9 (p < 0.001), QoL from 4.7 ± 1.4 to 1.2 ± 0.8 (p < 0.001), ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12428793/

Real-World Clinical Outcomes of Transperineal Laser ... We observed significant and progressive improvements in IPSS, Qmax, PVR, and prostate volume over a 12-month follow-up. Additionally, ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S2214388223000681

Transperineal laser ablation of the prostate as a treatment ... Conclusion. Echolaser® TPLA is a safe and effective procedure that treats BPH and localized PCa with satisfactory functional and sexual outcomes.

4. clinicaltrials.gov clinicaltrials.gov/study/NCT04760483

Office Based Transperineal Laser Ablation for Benign ... 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 ...

5. bjui-journals.onlinelibrary.wiley.com bjui-journals.onlinelibrary.wiley.com/doi/full/10.1002/bco2.278

Transperineal laser ablation as treatment for benign prostatic ... Functional outcomes increased significantly, up to 50% at 12 months. TPLA adds a new technique to the landscape of minimally invasive treatments ...

6. sciencedirect.com sciencedirect.com/science/article/pii/S2666168322000593

Prostate Cancer Safety and Feasibility of Soractelite ... TPLA for the treatment of PCa at the outpatient clinic appears to be safe and feasible with good short-term QoL and functional outcomes.