The PRIMARY Score: Using intra-prostatic PSMA PET/CT patterns to optimise prostate cancer diagnosis.

作者：Louise Emmett, Nathan Papa, James P Buteau, Bao Ho, Victor Liu, Matthew J. Roberts, James Thompson, Daniel Moon, Gemma Sheehan‐Dare, Omar Alghazo, Shikha Agrawal, Declan G. Murphy, Phillip D. Stricker, Thomas A. Hope, Michael S. Hofman · 发表于：Journal of Nuclear Medicine · 年份：2022 · DOI：10.2967/jnumed.121.263448 · 被引用次数：122 · 研究领域：Prostate Cancer Diagnosis and Treatment、Prostate Cancer Treatment and Research、Radiomics and Machine Learning in Medical Imaging

Background: Multi-parametric magnetic resonance imaging (mpMRI) is validated for the diagnosis of clinically significant prostate cancer (csPCa). 68Ga-PSMA -11 PET/CT (PSMA-PET/CT) combined with mpMRI has improved negative predictive value over mpMRI alone for csPCa. The aim of this post-hoc analysis of the PRIMARY study was to evaluate the clinical significance of patterns of intra-prostatic PSMA activity, proposing a 5- point PRIMARY score to optimise accuracy of PSMA-PET/CT for csPCa in a low prevalence population. Methods: The PRIMARY trial is a prospective multi-centre phase II imaging trial that enrolled biopsy-naïve men with suspected PCa, no prior biopsy, recent mpMRI (6 months) and planned for prostate biopsy. 291 men underwent mpMRI, PSMA-PET/CT and systematic +/- targeted biopsy. The mpMRI was read separately using PI-RADS (V2). PSMA-PET/CT (pelvic only) was acquired a minimum 60 minutes post injection. PSMA-PET/CT was centrally read for pattern (diffuse transition zone (TZ), symmetrical central zone (CZ), focal TZ or peripheral zone (PZ), and intensity (SUVmax). In this post-hoc analysis, a 5-level PRIMARY score was assigned based on analysis of the central read: 1. No pattern, 2. Diffuse TZ or CZ (no focal), 3. Focal TZ, 4. Focal PZ or 5. SUVmax ≥ 12. Two further readers independently assigned a PRIMARY score to 118 scans for inter-rater agreement. Associations between PRIMARY score and csPCa (ISUP≥2) were evaluated. Results: Of 291 men enrolled, 162 (56%) had cs...