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

NARecruitingINTERVENTIONAL
Enrollment

20

Participants

Timeline

Start Date

March 16, 2022

Primary Completion Date

January 27, 2023

Study Completion Date

January 30, 2033

Conditions
Prostate CancerAdverse Effects SurgeryMRIUltrasoundSexual Function DisturbancesUrinary IncontinenceUrinary Function DisordersProstate BiopsyAblation
Interventions
DEVICE

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.

Trial Locations (1)

33016

RECRUITING

Urology Specialist Group, Hialeah

All Listed Sponsors
lead

Urological Research Network, LLC

OTHER