• Abel Swaan, Christophe K Mannaerts, Matthijs Jv Scheltema, Jakko A Nieuwenhuijzen, C Dilara Savci-Heijink, Jean Jmch de la Rosette, van Moorselaar R Jeroen A RJA http://orcid.org/0000-0002-2559-9254 Department of Urology, VU University Medical Center, VU University, Amsterdam, Neth, Ton G van Leeuwen, Theo M de Reijke, and Daniel Martijn de Bruin.
• Department of Urology, Academic Medical Center, University of Amsterdam, Amsterdam, Netherlands.
• JMIR Res Protoc. 2018 May 21; 7 (5): e132.

BackgroundFocal therapy for prostate cancer has been proposed as an alternative treatment to whole-gland therapies in selected men to diminish side effects in localized prostate cancer. As nowadays imaging cannot offer complete prostate cancer disease characterization, multicore systematic biopsies are recommended (transrectal or transperineal). Optical imaging techniques such as confocal laser endomicroscopy and optical coherence tomography allow in vivo, high-resolution imaging. Moreover, they can provide real-time visualization and analysis of tissue and have the potential to offer additive diagnostic information.ObjectiveThis study has 2 separate primary objectives. The first is to assess the technical feasibility and safety of in vivo focal imaging with confocal laser endomicroscopy and optical coherence tomography. The second is to identify and define characteristics of prostate cancer and normal prostate tissue in confocal laser endomicroscopy and optical coherence tomography imaging by comparing these images with the corresponding histopathology.MethodsIn this prospective, in vivo feasibility study, needle-based confocal laser endomicroscopy and optical coherence tomography imaging will be performed before transperineal template mapping biopsy or radical prostatectomy. First, confocal laser endomicroscopy and optical coherence tomography will be performed in 4 patients (2 for each imaging modality) undergoing transperineal template mapping biopsy to assess the feasibility and safety of confocal laser endomicroscopy and optical coherence tomography. If proven to be safe and feasible, confocal laser endomicroscopy and optical coherence tomography will be performed in 10 patients (5 for each imaging modality) undergoing radical prostatectomy. Confocal laser endomicroscopy and optical coherence tomography images will be analyzed by independent, blinded observers. Confocal laser endomicroscopy- and optical coherence tomography-based qualitative and quantitative characteristics and histopathology will be compared. The study complies with the IDEAL (Idea, Development, Exploration, Assessment, Long-term study) stage 2a recommendations.ResultsAt present, the study is enrolling patients and results and outcomes are expected in 2019.ConclusionsConfocal laser endomicroscopy and optical coherence tomography are promising optical imaging techniques that can visualize and analyze tissue structure, possible tumor grade, and architecture in real time. They can potentially provide real-time, high-resolution microscopic imaging and tissue characteristics of prostate cancer in conjunction with magnetic resonance imaging or transrectal ultrasound fusion-guided biopsy procedures. This study will provide insight into the feasibility and tissue-specific characteristics of confocal laser endomicroscopy and optical coherence tomography for real-time optical analysis of prostate cancer.Trial RegistrationClinicalTrials.gov NCT03253458; https://clinicaltrials.gov/ct2/show/NCT03253458 (Archived by WebCite at http://www.webcitation.org/6z9owM66B).Registered Report IdentifierRR1-10.2196/9813.©Abel Swaan, Christophe K Mannaerts, Matthijs JV Scheltema, Jakko A Nieuwenhuijzen, C Dilara Savci-Heijink, Jean JMCH de la Rosette, R Jeroen A van Moorselaar, Ton G van Leeuwen, Theo M de Reijke, Daniel Martijn de Bruin. Originally published in JMIR Research Protocols (http://www.researchprotocols.org), 21.05.2018.

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