PT  - JOURNAL ARTICLE
AU  - Shi, Jingyan
AU  - Li, Danyan
AU  - Chen, Mengxia
AU  - Fu, Yao
AU  - Peng, Shan
AU  - Zhang, Qing
AU  - Liang, Jing
AU  - Lu, Qun
AU  - Lu, Jiaming
AU  - Ai, Shuyue
AU  - Wang, Feng
AU  - Qiu, Xuefeng
AU  - Guo, Hongqian
TI  - The Value of <sup>68</sup>Ga-PSMA PET/MRI for Classifying Patients with PI-RADS 3 Lesions on Multiparametric MRI: A Prospective Single-Center Study
AID  - 10.2967/jnumed.123.266742
DP  - 2024 Apr 01
TA  - Journal of Nuclear Medicine
PG  - 555--559
VI  - 65
IP  - 4
4099  - http://jnm.snmjournals.org/content/65/4/555.short
4100  - http://jnm.snmjournals.org/content/65/4/555.full
SO  - J Nucl Med2024 Apr 01; 65
AB  - Prostate Imaging Reporting and Data System (PI-RADS) category 3 lesions remain a diagnostic challenge for detecting clinically significant prostate cancer (csPCa). This article evaluates the added value of 68Ga-labeled prostate-specific membrane antigen-11 (68Ga-PSMA) PET/MRI in classifying PI-RADS 3 lesions to avoid unnecessary biopsies. Methods: Sixty biopsy-naïve men with PI-RADS 3 lesions on multiparametric MRI were prospectively enrolled between February 2020 and October 2022. In all, 56 participants underwent 68Ga-PSMA PET/MRI and prostate systematic biopsy. 68Ga-PSMA PET/MRI was independently evaluated and reported by the 5-level PRIMARY score developed within the PRIMARY trial. Receiver-operating-characteristic curve analysis was used to estimate the diagnostic performance. Results: csPCa was detected in 8 of 56 patients (14.3%). The proportion of patients with csPCa and a PRIMARY score of 1, 2, 3, 4, and 5 was 0% (0/12), 0% (0/13), 6.3% (1/16), 38.5% (5/13), and 100% (2/2), respectively. The estimated area under the curve of the PRIMARY score was 0.91 (95% CI, 0.817–0.999). For a PRIMARY score of 4–5 versus a PRIMARY score of 1–3, the sensitivity, specificity, positive predictive value, and negative predictive value were 87.5%, 83.3%, 46.7%, and 97.5%, respectively. With a PRIMARY score of at least 4 to make a biopsy decision in men with PI-RADS 3 lesions, 40 of 48 patients (83.3%) could avoid unnecessary biopsies, at the expense of missing 1 of 8 (12.5%) csPCa cases. Conclusion: 68Ga-PSMA PET/MRI has great potential to classify patients with PI-RADS 3 lesions and help avoid unnecessary biopsies.