Safety and Feasibility of Soractelite Transperineal Focal Laser Ablation for Prostate Cancer and Short-term Quality of Life Analysis from a Multicenter Pilot Study
Luigi A.M.J.G. van Riel, Rob A. A. van Kollenburg, André N. Vis, Pim J. van Leeuwen, Theo M. de Reijke, Daniël M. de Bruin, Jorg R. Oddens
Abstract
Background: Soractelite™ transperineal focal laser ablation (TPLA) for the treatment of localized prostate cancer (PCa) using the Echolaser® system is a novel minimally invasive technique that has the potential to induce tissue ablation, while reducing treatment-related morbidity, when compared with robot-assisted radical prostatectomy (RARP) and radiotherapy. Objective: To determine the short-term safety and feasibility of single or multifiber TPLA, its functional outcomes, and quality of life (QoL). Design setting and participants: TPLA was performed in 12 patients, consecutively assigned to four treatment regimens, with localized PCa who were scheduled for RARP ("ablate and resect design"). The treatment regimens were as follows: (1) a single fiber at 3 W, (2) two fibers at 5 mm distance at 3 W, (3) two fibers at 10 mm distance at 3 W, and (4) a single fiber at 5 W. TPLA was scheduled 4 wk prior to RARP. Intervention: TPLA using the Echolaser® system under local anesthesia at the outpatient clinic. Outcome measurements and statistical analysis: Safety and feasibility were determined by the assessment of device-related peri- and postoperative adverse events (AEs), and length of hospital stay. Functional outcomes and QoL were measured using validated questionnaires. Feasibility of RARP was assessed by a questionnaire for the urologist. Results and limitations: Patients were dismissed after a median (interquartile range) hospital admission of 3.25 (1.25) h. No device-related AEs occurred. AEs that occurred were mostly related to lower urinary tract symptoms and were mild (grade 1-2). Most AEs resolved within 1 wk. A QoL analysis showed no significant differences for all treatment regimens. Functional outcomes remained unchanged, except for erectile function after 1 wk, which returned to baseline after 4 wk. TPLA treatment did not compromise RARP, based on the questionnaires. Conclusions: TPLA for the treatment of PCa at the outpatient clinic appears to be safe and feasible with good short-term QoL and functional outcomes; oncological results are awaited. Patient summary: Focal treatment of localized prostate cancer can safely be performed in a daycare setting using a new technique, based on laser ablation, without compromising quality of life.