What side effects are associated with this type of intervention?

Common treatments for urinary incontinence include surgical procedures like tension-free vaginal tape (TVT) and transobturator tape (TOT), as well as non-surgical options like laser therapy. TVT and TOT can lead to side effects such as urinary tract infections, pain, and in some cases, exacerbation of mixed urinary incontinence (MUI). Laser therapy, which is similar to LITT in its use of laser technology, has shown efficacy with fewer side effects, primarily involving temporary discomfort and mild irritation. Overall, laser therapy tends to have a more favorable side effect profile compared to traditional surgical methods.

What prior FDA approvals exist?

FDA-approved treatments for urinary incontinence primarily include pharmacologic therapies such as antimuscarinics (e.g., tolterodine, solifenacin) and beta-3 adrenergic agonists (e.g., mirabegron). These medications work by relaxing the bladder muscle to reduce urgency and frequency. While Laser Induced Thermal Therapy (LITT) is being studied for prostate cancer, similar laser-based ablation techniques for urinary incontinence are not commonly used or FDA-approved. Instead, surgical options like transurethral resection of the prostate (TURP) and minimally invasive procedures such as transurethral microwave thermotherapy (TUMT) are more prevalent for treating related conditions like benign prostatic hyperplasia (BPH), which can contribute to urinary symptoms.

What other types of research exist?

Promising novel alternatives to Laser Induced Thermal Therapy (LITT) for urinary incontinence patients considering treatment in 2024 include: 1. Transurethral resection of the prostate (TURP) using bipolar or monopolar techniques, which are less invasive and have shown effectiveness in managing benign prostatic hyperplasia. 2. Photoselective vaporization of the prostate (PVP) using GreenLight laser, which is effective and has a lower risk of bleeding, making it suitable for patients on anticoagulation therapy. 3. Holmium laser enucleation of the prostate (HoLEP), which is effective for larger prostates and has a lower risk of complications. These alternatives focus on minimally invasive techniques that aim to preserve urinary function while effectively treating the underlying condition.

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Procedure

Laser Ablation for Prostate Cancer (TPF-LITT Trial)

N/A

Recruiting

Led By Fernando J Bianco, MD

Research Sponsored by Urological Research Network, LLC

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Prostate volume: ≥ 18 and ≤ 100 cc, measured by MRI

Presence of Intermediate risk prostate cancer with a volume that is less than 1/3 of the gland volume by MRI evaluation

Must not have

Major neurological conditions such as Alzheimer's, Parkinson, Multiple sclerosis, ALS, spinal cord injury

Medical contraindication to being subjected to local anesthesia

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1 year

Awards & highlights

No Placebo-Only Group

Summary

This trial tests a new laser treatment for men aged 50-80 with certain types of prostate cancer. The laser heats and destroys cancer cells, guided by advanced imaging to protect healthy tissue. The goal is to reduce side effects like impotence and incontinence seen with traditional treatments. Recently, there has been an increase in research and development of targeted prostate cancer treatments due to the high number of localized prostate cancers.

Who is the study for?

Men aged 50-80 with low to intermediate risk prostate cancer, who can consent and follow the study plan. They should have a prostate size of 18-100 cc by ultrasound or MRI, PSA <20 ng/ml, no urinary retention, creatinine levels <2 ng/dl with GFR >45. Excluded are those with neurogenic bladder issues, poor sexual function scores (SHIM score <14), surgery risks like infection or coagulopathy, high post-void residual urine volume (>250 mL), prior prostate cancer treatments or major neurological conditions.

What is being tested?

The trial tests TRANBERG® TPF-LITT for treating prostate tumors in an office setting under local anesthesia. It aims to preserve organ function while targeting tumor ablation using fusion imaging guidance. The study will evaluate safety and tolerance of this minimally invasive procedure and its effects on urinary and sexual functions as well as MRI changes in the treated area over time.

What are the potential side effects?

Potential side effects may include discomfort from the laser therapy itself, possible impacts on urinary function leading to incontinence issues, changes in sexual function including erectile dysfunction or altered ejaculation following treatment.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My prostate size is between 18 and 100 cc according to an MRI.

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My prostate cancer is at an intermediate risk level and occupies less than a third of my prostate.

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I do not have problems emptying my bladder completely.

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My prostate size is between 18 and 100 cc as measured by ultrasound.

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My kidney function is normal, with creatinine levels below 2 ng/dl and GFR above 45.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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

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I cannot have local anesthesia due to health reasons.

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I cannot have TPFLA surgery due to a health condition like an infection or heart risk.

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I have acute prostatitis.

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I have had radiation therapy or major surgery in my pelvic area.

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I have visible blood in my urine without any known cause.

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I have bladder stones.

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I have had treatments like radiation or cryoablation for prostate cancer.

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I had surgery for colorectal cancer involving the removal of part of my rectum.

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I have a bleeding or blood clotting disorder.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~1 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] of TRANBERG® TPF-LITT performed in the office setting under local anesthesia.

Secondary study objectives

Average Ablated area volume (in cc) measured by MRI 1-month following the procedure

Average Ablated area volume (in cc) measured by MRI 1-year following the procedure

Average Ablated area volume (in cc) measured by MRI 3-month following the procedure

+7 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: TPF-LITT ARMExperimental Treatment1 Intervention

partial gland ablation of the prostate using laser device and imaging fusion

0 / 15Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for urinary incontinence include pelvic floor muscle training, medications, and surgical interventions. Pelvic floor muscle training strengthens the muscles that support the bladder, improving control over urination. Medications such as anticholinergics reduce bladder muscle spasms, while beta-3 agonists relax the bladder muscle to increase storage capacity. Surgical options like sling procedures provide support to the urethra, preventing leakage. These mechanisms are crucial as they target the underlying causes of incontinence, offering relief and improving quality of life. While LITT focuses on ablating cancerous tissue using laser-induced heat, its principle of targeted tissue modification can be conceptually related to surgical interventions in incontinence treatment, where precise anatomical corrections are made to restore function.