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

The field of urology currently demands better options for men diagnosed with prostate cancer, the most common solid tumor in the US and Western Europe. Recently, active surveillance has become a main alternative for patients and physicians seeking to avoid the overtreatment phenomenon associated with standard treatments. However, most men on surveillance protocols for prostate cancer end up converting to "definitive" management whether surgery or radiation within 5 years from diagnosis.

The TRANBERG®|Thermal Therapy System (Clinical Laserthermia Systems AB. Scheelevägen 2 | 223 81 Lund, Sweden), is a 25 W, 1064 nm diode laser. It uses a disposable laser applicator 14G that allows the insertion of a laser applicator (15G) with a fiberoptic core of 550µm. This thermal therapy laser system is indicated for minimal invasive ablation procedures so called Laser Induced Thermal Therapy (LITT) or also called Laser Ablation for prostate treatments. During LITT, light causes damage in tissue due to absorption of light and through heat conduction into the tissue of the absorbed energy. Light tissue interaction is reliable, reproducible, and safe. The laser fiber tip induces necrosis near the tip and coagulative effects deeper in tissues through heat conduction. The body cleans up treated tissue over time. Much experience is gained with laser ablation in different organs.

The development of medical fusion devices that incorporate the precise diagnostic findings from MRI with the flexibility of ultrasound has expanded the precision of prostate biopsies and has led thinking into the current management of prostate cancer, opening for consideration the case for partial gland ablation as an option with fewer side effects.12 Conceivably, the most promising role of fusion imaging would be in the management spectrum of prostate cancer. 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. A better understanding on their role in ablation treatments is imperative.

The Focalyx® Fusion (Focalyx, 2140 West 68th St, #204a. Miami Lakes, FL, USA) is a novel disruptive medical device that enables an office based transperineal approach to be conducted using real-time fusion. The characteristics of this fusion device and trials studies have been well documented. This theoretically makes available a safe and laser fiber energy delivery that results in expedient and short procedure times. 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. However, targeted prostate cryoablation carries some intrinsic disadvantages as it requires high pressure gasses. Argon and helium are not readily available worldwide, and its efficacy depends on several timely cycles demanding procedure times of about an hour or more. LITT can be accomplished in efficient minutes treatment times and can address the multi-focality of prostate cancer quite effectively. Laser ablation has proven effective when conducted in an MRI bore, however, the immensity of these machines, limited size of the bore, prone positioning and constant in and out verification makes this approach not practical. Fusion laser ablation for prostate cancer is a novel concept that can bring together the precision of MRI with the practicality of ultrasound.

The combination of the TRANBERG® laser and the FOCALYX® Fusion medical device will allow us to perform targeted transperineal fusion laser induced thermal therapy (TPF-LITT) of prostate cancer lesions. This approach portends significant advantages that the investigators can consider, among them: lesion directed ablation, sparring of critical organs and structures such as the bladder neck, NVB, urethral sphincter and rectum. Moreover, healthy tissue is spared and can perform its function, if it mirrors what the investigators have accomplished with target fusion cryoablation. It shall be expected that most men will have preservation of some ejaculation, mild changes in sexual function and no incontinence following treatment with TPF-LITT. In fact, from a urinary function status, the investigators expect patients to suffer no harm either subjectively or objectively. However, all these thoughts require rigorous evaluation. Today, there is no data or evaluation of its safety profile if/when conducted in an office setting under local anesthesia. Therefore, in this study, the principal aim is to assess tolerability and safety profile of TRANBERG® TPF-LITT conducted in men with Prostate Cancer in the office setting.