Journal: European Urology Open Science
Published: July 19, 2020
Author: Peltier et al.
Hospital: Institut Jules Bordet, Dept. of Urology, Belgium
DOI: https://www.eu-openscience.europeanurology.com/article/S2666-1683(20)33485-6/pdf
INTRODUCTION AND OBJECTIVES: Through an ablate-and-resect study, we evaluated the feasibility, safety and histological effects of very low loss (VLL) microwave ablation, performed transrectally under real-time MRI/TRUS image registration and 3D mapping, in patients with localized prostate cancer (PCa).
MATERIALS AND METHODS: Patients with a detectable index lesion on mpMRI, PSA level <20 ng/mL and wishing to undergo a prostatectomy in case of significant PCa on biopsy were eligible for this study approved by Ethics Committee. Targeted biopsies of the index lesion were performed by using an ultrasound-MRI image fusion system with OBT-registration (Trinity®, KOELIS, France) to provide quality control. Targeted cores were analyzed intraoperatively with an extemporaneous analysis. If positive, the patients were treated during the same session by a targeted focal microwave ablation using a single 18G needle inserted transrectally under sedation. Predictive ablation charts obtained with the microwave generator (TATO, Biomedical Srl, Italy) through in vitro experiments were used to choose the duration and power of the treatment. Treated patients were followed-up for 4 to 6 weeks and the planned radical prostatectomy was performed. All patients underwent uroflowmetry test and filled the self-administered questionnaires (IPSS, IPSS-QOL, IIEF-5, and MSHQ-EjD-SF) before the intervention, at 7 days and 1 month after the procedure. A mpMRI of the treated prostate was performed at 7 days. After radical prostatectomy, whole-mount histology served to define the ablation boundaries and dimensions in the prostate. A total of 10 patients will be operated.
RESULTS: From January to June 2019, 5 patients participated in this ablate-and-resect study without therapeutic intent. Microwave ablation was performed on 4 patients. One patient did not receive the treatment due to negative targeted biopsies and was exited from the study. Another one withdrew his consent after microwave ablation and thus did not undergo radical prostatectomy. He is now under active surveillance. All procedures were performed under sedation in an outpatient setting, with a median intervention time of 81.5 min [63.75-96.5]. After 4 interventions, no patient reported any pain and no serious adverse event was observed. The early postoperative mpMRI showed consistent devascularization on the T1 DCE MRI at the treatment site. A sharp necrosis was also observed on the whole-mount sections. Further interventions will allow to compare clinical observations with the predictive charts.
CONCLUSION: Our pilot study demonstrated that microwave ablation guided by OBT-fusion in patients with localized PCa is safe, feasible and easily deliverable in an outpatient setting. Histopathological analyses confirm a well-delimited ablation shape.