RT Journal Article SR Electronic T1 Diagnostic performance and clinical impact of 68Ga-PSMA-11 imaging in early relapsed prostate cancer after radical therapy: a prospective multicenter study (IAEA-PSMA study). JF Journal of Nuclear Medicine JO J Nucl Med FD Society of Nuclear Medicine SP jnumed.120.261886 DO 10.2967/jnumed.120.261886 A1 Juliano Julio Cerci A1 Stefano Fanti A1 Enrique E. Lobato A1 Jolanta Kunikowska A1 Omar Alonso A1 Sevastian Medina A1 Fuad Novruzov A1 Thabo Lengana A1 Carlos Granados A1 Rakesh Kumar A1 Venkatesh Rangarajan A1 Akram Al-Ibraheem A1 Mukbil Hourani A1 Nor S Ali A1 Azra Ahmad A1 Zohar Keidar A1 Ozlem Kucuk A1 Umut Elboga A1 Mateos Bogoni A1 Diana Paez YR 2021 UL http://jnm.snmjournals.org/content/early/2021/07/08/jnumed.120.261886.abstract AB Biochemical recurrence (BCR) is a clinical challenge in prostate cancer (PCa) patients as recurrence localization guides subsequent therapies. The use of positron emission tomography (PET) with prostate-specific membrane antigen (PSMA) presents better accuracy than standard imaging practice. This prospective, multicenter, international study evaluates the diagnostic performance and clinical impact of PSMA-PET/CT in evaluating BCR in Pca in a worldwide scenario. Methods: Patients were recruited from 17 centers in 15 countries. Inclusion encompassed histopathology-proven prostatic adenocarcinoma with previous primary treatment and clinically established BCR, with serum PSA < 4 ng/mL or < 10 ng/mL with negative MR and bone scintigraphy. All patients underwent PET/CT scanning with 68Ga-PSMA-11 as radiotracer. Images and data were centrally reviewed. Multivariate logistic regression analysis was applied to identify the independent predictors of positive PSMA results. Variables were selected for this regression model based on significant associations in the univariate analysis and previous clinical knowledge: Gleason Score, PSA at PET, PSA doubling time and primary treatment strategy. All patients were followed for a minimum of 6 months. Results: From a total of 1004 patients, 77.7% were treated initially with radical prostatectomy while 22.3% with radiotherapy. Overall 65.1% presented PSMA-PET/CT positive scans. PSMA-PET/CT positivity was correlated with Gleason score, PSA at PET time, PSA doubling time and radiotherapy as primary treatment (p<0.001). Treatment was modified based on PSMA-PET/CT results in 56.8% of patients. PSMA-PET/CT positivity rates were consistent and not statistically different among different income countries. Conclusion: This multicenter international prospective trial on PSMA-PET/CT confirms its capability in detecting local and metastatic recurrence in most prostate cancer patients in the setting of biochemical recurrence. PSMA-PET/CT positivity was correlated with Gleason score, PSA at PET, PSA doubling time and radiotherapy as primary treatment. PSMA-PET/CT results led to changes in therapeutic management in more than half of the cohort. The study demonstrates the reliability of PSMA-PET/CT in the workup of PCa patients with BCR, and its worldwide feasibility.