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.
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
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
Single group
TRANBERG® Transperineal Fusion Laser--Induced Thermal Therapy of Prostate Cancer (TPF-LITT)
DeviceA 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.
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] of TRANBERG® TPF-LITT performed in the office setting under local anesthesia.
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
Average Ablated area volume (in cc) measured by MRI immediately following the procedure
patients will undergo a multiparametric MRI immediately after the procedure and the ablated areas will be contoured and the dimensions on cubic centimeters will be recorded as ablation area
Average Ablated area volume (in cc) measured by MRI 1-month following the procedure
patients will undergo a multiparametric MRI 30 days (1-month) after the procedure and the ablated areas will be contoured and the dimensions on cubic centimeters will be recorded as ablation area
Average Ablated area volume (in cc) measured by MRI 3-month following the procedure
patients will undergo a multiparametric MRI 90 days (3-month) after the procedure and the ablated areas will be contoured and the dimensions on cubic centimeters will be recorded as ablation area
Average Ablated area volume (in cc) measured by MRI 1-year following the procedure
patients will undergo a multiparametric MRI 1-year after the procedure and the ablated areas will be contoured and the dimensions on cubic centimeters will be recorded as ablation area
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