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

TRANBERG® Transperineal MR/US Focalyx Fusion Laser--Induced Thermal Therapy in the Office Setting Under Local Anesthesia

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
50 Years to 80 Years
Sex
Male only
Healthy volunteers
Accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Procedures mentioned: MRI scans, Biopsies, Ultrasound, Questionnaires

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "MRI/US fusion imaging has tremendous advantages, it delivers precise anatomical boundaries and perspectives to surgeons as they sought to destroy cancer lesions and spare healthy tissue."
  • "The Focalyx® Fusion has been used safely in the transperineal diagnosis (fusion biopsies) and management (fusion targeted cryoablation) of men with Prostate Cancer in the office setting."
  • "Fusion laser ablation for prostate cancer is a novel concept that can bring together the precision of MRI with the practicality of ultrasound."
  • "Upon conclusion of the procedure, the patient will have a multiparametric MRI of the prostate to determine the extent of ablation with this powerful technology immediately after treatment, and subsequently 1, 3 and 12 months after."
  • "Cancer control will be measured with MRI at several milestones, serum PSA changes during the year and the definitive measure will be a Transperineal MR/US Fusion Biopsy at one year of follow up."
  • "Urinary and Sexual functional outcomes will be determined by evaluating changes in the validated questionnaires."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests the safety of using laser heat to destroy prostate cancer tumors, guided by combined MRI and ultrasound images. It is for men ages 50 to 80 with low- to medium-risk prostate cancer. Treatment takes place in an office with medicine to numb the area.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Able and willing to sign a consent form and attend all treatment and follow-up visits.
  • Able to empty the bladder without urine getting trapped.
  • Prostate size of 18 to 100 cc on both ultrasound and MRI scans.
  • Kidney test results: creatinine below 2 ng/dl and GFR above 45.
  • PSA blood test level below 20 ng/ml.
  • Prostate MRI score called PI-RADS of 3 to 5.
  • Medium-risk prostate cancer taking up less than one-third of the prostate on MRI.

Who can't join

  • More than 250 mL of urine left in the bladder after peeing, or more than half the amount passed; a urine drainage tube or regular tube use in the past 30 days.
  • Past prostate cancer treatment, pelvic radiation, major pelvic surgery, or rectal cancer with the listed surgery to remove the rectum.
  • Major nerve or brain disease, such as Alzheimer's, Parkinson's, multiple sclerosis, ALS, or spinal cord injury; bladder problems caused by nerve damage.
  • An active urine infection, sudden prostate inflammation, bladder stones, or visible blood in urine with no known cause.
  • A sexual function score (SHIM) below 14 or a urinary symptom score (IPSS) above 23.
  • Narrowing at the bladder opening or in the tube that carries urine out within the past 5 years.
  • A known or suspected bleeding or blood-clotting disorder.
  • A health problem that makes the procedure or numbing medicine unsafe, such as infection or serious heart problems.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

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 sites (1)

FL