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

  • Recruiting
  • Treatment
  • Interventional
  • Device
  • Urological Research Network, LLC
  • 50 - 80 Years


Study Purpose

This study is set up as a phase I prospective, single center, device interventional pilot study carried in office setting under local anesthesia. It will assess the tolerance and safety of target fusion ablation of prostate cancer tumors using Laser Induced Thermal Therapy (TFA-LITT) guided by fusion imaging in men 50 to 80 years of age with low to intermediate risk prostate cancer Prostate Cancer is currently managed with in a discrete fashion where patients either enroll in active surveillance protocols (No intervention) or undergo full intervention via whole gland treatments - most commonly radical surgery or radiation. These treatments have not shown definitive gains in all cause survival and not uncommonly harbor undesirable adverse effects, most notably: impotency and incontinence. Such events elicit significant and noticeable changes on a male lifestyle and for most prostate cancer tumors are considered overtreatment. This study aims to evaluate the use of TFA-LITT in the office setting under local anesthesia - greatly decreasing patient perioperative surgical risk - focused on the organ sparing cancer lesion ablation, where organ function is preserved. The fundamental objective is to determine the tolerance and safety of TFA-LITT in men with low to intermediate risk prostate cancer, successful performed in the outpatient office-based setting under local anesthesia directed by fusion imaging. Secondary objectives include: 1-Biopsy proven cancer control of ablated areas 12 months after procedure; 2-Uroflowmetry and urinary function Patient Reported Outcome Measures (PROMs) at one, three, six, nine and 12 months; 3- Sexual function Patient Reported Outcome Measures (PROMs) at one, three, six, nine and 12 months; 4- MRI changes of ablated area one, three and 12 months after TFA-LITT; 5- Absence or presence of ejaculation after TFA-LITT.

Intervention

Device : TRANBERG® Transperineal Fusion Laser--Induced Thermal Therapy of Prostate Cancer (TPF-LITT)


Eligibility Requirements

info icon Willing and able to sign informed consent

info icon Subject is able and willing to complete all procedure and follow-up visits indicated in the protocol

info icon Absence of urinary retention

info icon Prostate volume: ≥ 18 and ≤ 100 cc, measured by transrectal ultrasound

info icon Serum creatinine levels \<2 ng/dl and GFR \> 45

info icon Serum PSA levels \< 20 ng/ml

info icon Multiparametric prostate MRI with piRADS scores 3-5

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

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

info icon Minimum age: 50

info icon Post-void residual (PVR): \> 250 mL or \> 50% of voided volume

info icon Previous prostate cancer intervention (Radiation therapy, brachytherapy, prostate cryoablation

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

info icon Evidence of neurogenic bladder determined by urodynamics studies

info icon Presence of Indwelling Foley catheter or on active regime of clean intermittent catheterization (CIC) in the prior 30 days

info icon Active urinary tract infection determined by urinary cultures

info icon SHIM score \<14

info icon IPSS score \>23

info icon Acute prostatitis

info icon Macroscopic hematuria without a known contributing factor

info icon History of colorectal carcinoma with anterior perineal resection of rectum

info icon History of pelvic radiation therapy or radical pelvic surgery

info icon History of bladder neck contracture and/or urethral strictures within the 5 years prior to the informed consent date

info icon Bladder stones

info icon Medical contraindication for undergoing TPFLA surgery (eg, infection, coagulopathy, significant cardiac or other medical risk factors for surgery)

info icon Diagnosed or suspected bleeding or coagulopathic disorder such as hemophilia, ITP, TTP

info icon Medical contraindication to being subjected to local anesthesia

Recruiting status

Recruiting

Estimated enrollment

20

 
Study start date

Mar 16, 2022

Study end date

Jan 30, 2033

Last updated

Mar 24, 2025

Primary purpose

Treatment

Design

Interventional

Intervention

Device

Study phase

NA

Allocation

Na

 

Sponsor:

Urological Research Network, LLC

Collaborator:

N/A

Investigator:

Fernando J Bianco, MD

Isabel H Lopez, BS., MBA

NCT05698576

Clinic Location Investigator Distance RECRUITING STATUS Contact