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TRANBERG® Laser Therapy for Prostate Cancer

This study is testing a new way to treat prostate cancer called TRANBERG® Transperineal Fusion Laser-Induced Thermal Therapy (TPF-LITT). This treatment uses a laser to heat and destroy prostate cancer cells. It's done in an office setting using local anesthesia (medicine to numb a small area). The study will look at how safe and tolerable this treatment is for men aged 50 to 80 with low to intermediate risk prostate cancer. Current prostate cancer treatments can have side effects like impotence and incontinence, so researchers are looking for better options. This study aims to see if TRANBERG® TPF-LITT can be a good alternative.

Study design
This is a pilot study involving 20 men. It is a single-center study, meaning it takes place at one location.
What's involved
You would need to be willing and able to complete all procedure and follow-up visits as outlined in the study plan.
Compensation
Not stated in the trial record.
Follow-up
The main safety and tolerability of the treatment will be measured at 90 days after the procedure.

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NCT05698576

TRANBERG® Transperineal MR/US Fusion Laser--Induced Thermal Therapy for Men With Prostate Cancer

Recruiting
NAAges 50–80InterventionalTreatment
Urological Research Network, LLC
~20 participants
Updated 2023-01-26 on ClinicalTrials.gov
What's tested:TRANBERG® Transperineal Fusion Laser--Induced Thermal Therapy of Prostate Cancer (TPF-LITT)

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] of TRANBERG® TPF-LITT performed in the office setting under local anesthesia.
Measured over 90 days

Conditions

Prostate Cancer
Adverse Effects Surgery
MRI
Ultrasound
Sexual Function Disturbances
Urinary Incontinence
Urinary Function Disorders
Prostate Biopsy
Ablation

Explore related trials

Prostate Carcinoma

Where it's being run

1 sites across 1 states
Florida1

Study leadership

  • Fernando J Bianco, MD · PRINCIPAL_INVESTIGATOR · Urological Research Network
  • Isabel H Lopez, BS., MBA · STUDY_DIRECTOR · Urological Research Network

Who to contact

Cielo D Guerra, BS
[email protected]
786-431-2014
Email the study team

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Eligibility criteria

Inclusion

Willing and able to sign informed consent
Subject is able and willing to complete all procedure and follow-up visits indicated in the protocol
Absence of urinary retention
Prostate volume: ≥ 18 and ≤ 100 cc, measured by transrectal ultrasound
Serum creatinine levels \<2 ng/dl and GFR \> 45
Serum PSA levels \< 20 ng/ml
Multiparametric prostate MRI with piRADS scores 3-5
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

Exclusion

Post-void residual (PVR): \> 250 mL or \> 50% of voided volume
Previous prostate cancer intervention (Radiation therapy, brachytherapy, prostate cryoablation
Major neurological conditions such as Alzheimer's, Parkinson, Multiple sclerosis, ALS, spinal cord injury
Evidence of neurogenic bladder determined by urodynamics studies
Presence of Indwelling Foley catheter or on active regime of clean intermittent catheterization (CIC) in the prior 30 days
Active urinary tract infection determined by urinary cultures
SHIM score \<14
IPSS score \>23
Acute prostatitis
Macroscopic hematuria without a known contributing factor
History of colorectal carcinoma with anterior perineal resection of rectum
History of pelvic radiation therapy or radical pelvic surgery
History of bladder neck contracture and/or urethral strictures within the 5 years prior to the informed consent date
Bladder stones
Medical contraindication for undergoing TPFLA surgery (eg, infection, coagulopathy, significant cardiac or other medical risk factors for surgery)
Diagnosed or suspected bleeding or coagulopathic disorder such as hemophilia, ITP, TTP
Medical contraindication to being subjected to local anesthesia

What this trial measures

  • Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] of TRANBERG® TPF-LITT performed in the office setting under local anesthesia.90 days

    Tolerability will be assessed during the execution of TFP-LITT at several phases of the treatment. An analog pain scale will be provided to the patient, whom will be asked to describe any pain scores at each of the following treatment successions: 1. superficial perineal block, 2. foley advancement, 3. deep perineal block, 4. fusion co-registration, 5. before and after each ablation, 6-Once the patient has recovered, he will be asked for an overall pain assessment. Safety will be evaluated by assessments of the 7-day, 30-day and 90-day AEs reported using the CTCAE scale, as perioperative assessments will be conducted at each of these milestones. A grade 3 or worse AEs based on the CTCAE v5.0 within 90 days post procedure will be considered severe. Any registered AEs will be labelled as follows: 1. Not related 2. Possible 3. Probable 4. Causal relationship