- 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
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
Minimum age: 50
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
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
Publications
Websites
NCT05698576
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