Recruiting

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

Sponsor:

Urological Research Network, LLC

Code:

NCT05698576

Conditions

Prostate Cancer

Adverse Effects Surgery

MRI

Ultrasound

Sexual Function Disturbances

Eligibility Criteria

Sex: Male

Age: 50 - 70+

Healthy Volunteers: Accepted

Interventions

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

Study Details

Brief summary:

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.

Conditions

Prostate Cancer

Adverse Effects Surgery

MRI

Ultrasound

Sexual Function Disturbances

Study ID

NCT05698576

Start date

Mar 16, 2022

Status verified date

Jan, 2023

Completion date

Jan 30, 2033

Anticipated

Primary completion date

Jan 27, 2023

Anticipated

Eligibility Criteria

Sex: Male

Age: 50 - 70+

Healthy Volunteers: Accepted

Inclusion Criteria:

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 Criteria:

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

Study Design

Enrollment

20 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: TPF-LITT ARM

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

Interventions

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

A perineal local anesthesia block is performed with patient on lithotomy. The ultrasound probe is advanced, secured to digital stepper. The live ultrasound image feed is visible on the FOCALYX® Fusion device. Image co-registration (MR/US) will be performed. The FOCALYX® Fusion device shows outline of the prostate on the MRI and the target area(s) in real-time. The urologist advances laser fiber introducer, temperature probes to indicated coordinates. Target treatment - applying TRANBERG® laser energy over the treatment area and controlling delivery with a pedal. Treatment is monitored using FOCALYX® Fusion device in real-time. One laser fiber will be used and a single or multiple applications may be required. The fiber will be relocated to other targets if present. Patient will be dismissed to the MRI center where a multiparametric MRI will be conducted. After this study is completed, the patient will be discharged home with instructions and contact information.

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Cielo D Guerra, BS

786-431-2014 cielo@besturology.net

Luanda Perez, PA.C

305-822-7227 luanda@besturology.net

Locations

Urology Specialist Group

Recruiting

Hialeah, Florida, United States, 33016

Contacts

Isabel H Lopez, MS, MBA

786-431-2014 isabel@research.surgery

Gabriela Soriano

7864312014 gabriela@besturology.net

More Information

Sponsor

Urological Research Network, LLC

Last update posted

Jan 26, 2023

Last verified

Jan, 2023

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Urological Research Network, LLC on 2023-01-26.