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

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.

Sex

Male

Minimum age

50 Years

Maximum age

80 Years

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

• BACKGROUNDCarter G, Clover K, Britton B, Mitchell AJ, White M, McLeod N, Denham J, Lambert SD. Wellbeing during Active Surveillance for localised prostate cancer: a systematic review of psychological morbidity and quality of life. Cancer Treat Rev. 2015 Jan;41(1):46-60. doi: 10.1016/j.ctrv.2014.11.001. Epub 2014 Nov 13. PMID 25467109
• BACKGROUNDCooperberg MR, Carroll PR, Klotz L. Active surveillance for prostate cancer: progress and promise. J Clin Oncol. 2011 Sep 20;29(27):3669-76. doi: 10.1200/JCO.2011.34.9738. Epub 2011 Aug 8. PMID 21825257
• BACKGROUNDHamdy FC, Donovan JL, Lane JA, Mason M, Metcalfe C, Holding P, Davis M, Peters TJ, Turner EL, Martin RM, Oxley J, Robinson M, Staffurth J, Walsh E, Bollina P, Catto J, Doble A, Doherty A, Gillatt D, Kockelbergh R, Kynaston H, Paul A, Powell P, Prescott S, Rosario DJ, Rowe E, Neal DE; ProtecT Study Group. 10-Year Outcomes after Monitoring, Surgery, or Radiotherapy for Localized Prostate Cancer. N Engl J Med. 2016 Oct 13;375(15):1415-1424. doi: 10.1056/NEJMoa1606220. Epub 2016 Sep 14. PMID 27626136
• BACKGROUNDLoeb S, Carter HB, Schwartz M, Fagerlin A, Braithwaite RS, Lepor H. Heterogeneity in active surveillance protocols worldwide. Rev Urol. 2014;16(4):202-3. No abstract available. PMID 25548550
• BACKGROUNDCooley LF, Emeka AA, Meyers TJ, Cooper PR, Lin DW, Finelli A, Eastham JA, Logothetis CJ, Marks LS, Vesprini D, Goldenberg SL, Higano CS, Pavlovich CP, Chan JM, Morgan TM, Klein EA, Barocas DA, Loeb S, Helfand BT, Scholtens DM, Witte JS, Catalona WJ; Collaborators. Factors Associated with Time to Conversion from Active Surveillance to Treatment for Prostate Cancer in a Multi-Institutional Cohort. J Urol. 2021 Nov;206(5):1147-1156. doi: 10.1097/JU.0000000000001937. Epub 2021 Sep 10. PMID 34503355
• BACKGROUNDAl-Hakeem Y, Raz O, Gacs Z, Maclean F, Varol C. Magnetic resonance image-guided focal laser ablation in clinically localized prostate cancer: safety and efficacy. ANZ J Surg. 2019 Dec;89(12):1610-1614. doi: 10.1111/ans.15526. Epub 2019 Nov 3.