Oncology - Prostate
Introduction & Objective : Greater than 90% of TRUS-guided prostate biopsy cores are histopathologically classified as benign. Optical spectroscopy allows characterization of tumors by measurement of spectral tissue properties. As tissue undergoes malignant growth, the optical properties change. Assessment of changes in tissue optical properties may permit the diagnosis of prostate cancer (PCa) at the time of biopsy. The objective of this study was to acquire and analyze spectral data and correlative tissue biopsy cores using the ClariCore™ Optical Biopsy System (COBS) for training and development of a prostate tissue classification algorithm.
Methods : COBS is comprised of a 16-gauge core biopsy needle with an integrated optical sensor and a console which provides real-time prostate tissue classification information prior to taking the biopsy. Auto advancing of the inner needle via a built-in motor allows tissue classification along the length of the core in 1 mm increments. Men > 22 years old, scheduled for TRUS-guided prostate biopsy with a prostate volume > 20 were included in this multicenter study. Using COBS, 10-12 tissue biopsy cores were targeted from each patient. Fluorescence spectra at 280 and 340 nm excitations and elastic scattering spectra between 400-750 nm were collected for every core in 1 mm steps. For each tissue core, 1 mm segments were histopathologically classified either as benign or malignant and correlated with respective spectra measurements.
Results : Of the 144 patients included in the intent to treat analysis, 142 (98.6%) had biopsy cores successfully collected with the COBS. In total, 1,158 biopsy cores collected with the COBS were used for algorithm development. Of these cores, 185 (16.0%) were found to contain PCa. The COBS algorithm performance results are provided in Table 1. During the course of the study no serious adverse events were reported.
Conclusions : This study demonstrated that COBS can successfully acquire spectral data and correlative tissue biopsy cores for algorithm development. High sensitivity and negative predictive value can be used for precise targeting of PCa lesionswith subsequent improvement in the diagnostic yield of TRUS-guided prostate biopsies. The COBS procedure was safe and well-tolerated by patients. Additional studies are underway to further establish ClariCore accuracy and clinical utility.