Comparison of diagnostic performance between manual diagnosis following PROMISE V2 and aPROMISE utilizing Ga/F-PSMA PET/CT.

Abstract

Backgrounds: Automated PROMISE (aPROMISE), which is an artificial intelligence-supported software for prostate-specific membrane antigen (PSMA) PET/CT based on PROMISE V2, has demonstrated diagnostic utility with better correspondence rates compared to manual diagnosis. However, previous studies have consistently utilized ¹⁸F-PSMA PET/CT. Therefore, we investigated the diagnostic utility of aPROMISE using both ¹⁸F- and ⁶⁸ Ga-PSMA PET/CT of Japanese patients with metastatic prostate cancer (mPCa).

Materials and methods: We retrospectively evaluated 21 PSMA PET/CT images (⁶⁸ Ga-PSMA PET/CT: n = 12, ¹⁸F-PSMA PET/CT: n = 9) from 21 patients with mPCa. A single, well-experienced nuclear radiologist performed manual diagnosis following PROMISE V2 and subsequently performed aPROMISE-assisted diagnosis to assess miTNM and details of metastatic sites. We compared the diagnostic time and correspondence rates of miTNM diagnosis between manual and aPROMISE-assisted diagnoses. Additionally, we investigated the differences in diagnostic performance between the two radioisotopes.

Results: aPROMISE-assisted diagnosis was significantly associated with shorter median diagnostic time compared to manual diagnosis (427 s [IQR: 370-834] vs. 1,114 s [IQR: 922-1291], p < 0.001). The time reduction with aPROMISE-assisted diagnosis was particularly notable when using ⁶⁸ Ga-PSMA PET/CT. aPROMISE had high diagnostic accuracy with 100% sensitivity for miT, M1a, and M1b stages. Notably, for M1b stages, aPROMISE achieved 100% sensitivity and specificity, regardless of the type of radioisotope used. However, aPROMISE was misinterpreted in lymph node detection in some cases and missed five visceral metastases (2 adrenal and 3 liver), resulting in lower sensitivity for miM1c stage (63%). In addition to detecting metastatic sites, aPROMISE successfully provided detailed metrics, including the number of metastatic lesions, total metastatic volume, and SUV mean.

Conclusions: Despite the preliminary nature of the study, aPROMISE-assisted diagnosis significantly reduces diagnostic time and achieves satisfactory accuracy compared to manual diagnosis. While aPROMISE is effective in detecting bone metastases, its limitations in identifying lymph node and visceral metastases must be carefully addressed. This study supports the utility of aPROMISE in Japanese patients with mPCa and underscores the need for further validation in larger cohorts.