Hiroyoshi Suzuki1, Yusuke Inoue2, Hiroyuki Fujimoto3, Junji Yonese4, Kazunari Tanabe5, Satoshi Fukasawa6, Tomio Inoue7, Shiro Saito8, Munehisa Ueno9, Akiharu Otaka10. 1. Department of Urology, Toho University Sakura Medical Center, Sakura hiroyoshi.suzuki@med.toho-u.ac.jp. 2. Department of Diagnostic Radiology, Kitasato University School of Medicine, Sagamihara. 3. Department of Urology, National Cancer Center Hospital, Tokyo. 4. Department of Urology, Cancer Institute Hospital, Japanese Foundation for Cancer Research, Tokyo. 5. Department of Urology, Tokyo Women's Medical University, Tokyo. 6. Prostate Center and Division of Urology, Chiba Cancer Center, Chiba. 7. Department of Radiology, Yokohama City University Graduate School of Medicine, Yokohama. 8. Department of Urology, National Hospital Organization Tokyo Medical Center, Tokyo. 9. Department of Uro-Oncology, Saitama Medical University International Medical Center, Hidaka. 10. Clinical Development Department, Nihon Medi-Physics Co., Ltd., Tokyo, Japan.
Abstract
OBJECTIVE: We performed a multicenter Phase IIb clinical trial of NMK36, a novel amino acid analog for positron emission tomography containing trans-1-amino-3-[(18)F]fluorocyclobutanecarboxylic acid, to evaluate its safety and diagnostic performance for primary prostate cancer. METHODS: Sixty-eight subjects with primary prostate cancer scheduled for radical prostatectomy or hormone therapy underwent whole-body positron emission tomography/computed tomography after injection of NMK36. The diagnostic performances of NMK36-positron emission tomography/computed tomography were evaluated for (i) regional lymph node metastasis: comparison with contrast-enhanced computed tomography under setting reference standard (histopathology or 6-month follow-up), (ii) bone metastasis: concordance rate with conventional imaging (combination of bone scintigraphy and contrast-enhanced computed tomography) and (iii) primary lesion: comparison with histopathological findings. RESULTS: The accuracy of NMK36-positron emission tomography/computed tomography and contrast-enhanced computed tomography for regional lymph node metastasis were 85.5 and 87.3%, respectively. NMK36-positron emission tomography/computed tomography showed positive findings for regional lymph nodes with short-axis diameters of 5-9 mm at 23 regions in 13 patients of hormone therapy cohort, but they were not confirmed with reference standard in this study. The concordance rate of NMK36-positron emission tomography/computed tomography with conventional imaging for bone metastases was 83.3%, and seven patients had positive findings only by NMK36-positron emission tomography/computed tomography. The sensitivity and specificity of NMK36-positron emission tomography/computed tomography for primary lesion in six-segment analysis was 92.5 and 90.1%, respectively. Seven of non-serious adverse events were observed in six patients. CONCLUSIONS: This study showed the comparable diagnostic performance of NMK36-positron emission tomography/computed tomography compared with conventional imaging. Some lesions of lymph node and bone were positive solely by NMK36-positron emission tomography/computed tomography, which needs to be confirmed with reference standard in future study to evaluate the usefulness of NMK36-positron emission tomography/computed tomography in staging prostate cancer.
OBJECTIVE: We performed a multicenter Phase IIb clinical trial of NMK36, a novel amino acid analog for positron emission tomography containing trans-1-amino-3-[(18)F]fluorocyclobutanecarboxylic acid, to evaluate its safety and diagnostic performance for primary prostate cancer. METHODS: Sixty-eight subjects with primary prostate cancer scheduled for radical prostatectomy or hormone therapy underwent whole-body positron emission tomography/computed tomography after injection of NMK36. The diagnostic performances of NMK36-positron emission tomography/computed tomography were evaluated for (i) regional lymph node metastasis: comparison with contrast-enhanced computed tomography under setting reference standard (histopathology or 6-month follow-up), (ii) bone metastasis: concordance rate with conventional imaging (combination of bone scintigraphy and contrast-enhanced computed tomography) and (iii) primary lesion: comparison with histopathological findings. RESULTS: The accuracy of NMK36-positron emission tomography/computed tomography and contrast-enhanced computed tomography for regional lymph node metastasis were 85.5 and 87.3%, respectively. NMK36-positron emission tomography/computed tomography showed positive findings for regional lymph nodes with short-axis diameters of 5-9 mm at 23 regions in 13 patients of hormone therapy cohort, but they were not confirmed with reference standard in this study. The concordance rate of NMK36-positron emission tomography/computed tomography with conventional imaging for bone metastases was 83.3%, and seven patients had positive findings only by NMK36-positron emission tomography/computed tomography. The sensitivity and specificity of NMK36-positron emission tomography/computed tomography for primary lesion in six-segment analysis was 92.5 and 90.1%, respectively. Seven of non-serious adverse events were observed in six patients. CONCLUSIONS: This study showed the comparable diagnostic performance of NMK36-positron emission tomography/computed tomography compared with conventional imaging. Some lesions of lymph node and bone were positive solely by NMK36-positron emission tomography/computed tomography, which needs to be confirmed with reference standard in future study to evaluate the usefulness of NMK36-positron emission tomography/computed tomography in staging prostate cancer.
Authors: Divya Yadav; Hyunsoo Hwang; Wei Qiao; Rituraj Upadhyay; Brian F Chapin; Chad Tang; Ana Aparicio; Maria A Lopez-Olivo; Stella K Kang; Homer A Macapinlac; Tharakeswara K Bathala; Devaki Shilpa Surasi Journal: Radiol Imaging Cancer Date: 2022-03
Authors: Esther Mena; Peter C Black; Soroush Rais-Bahrami; Michael Gorin; Mohamad Allaf; Peter Choyke Journal: World J Urol Date: 2020-07-15 Impact factor: 4.226