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.
Journal of nuclear medicine : official publication, Society of Nuclear Medicine. 2021 Jul 02 [Epub ahead of print]
Juliano Julio Cerci, Stefano Fanti, Enrique E Lobato, Jolanta Kunikowska, Omar Alonso, Sevastian Medina, Fuad Novruzov, Thabo Lengana, Carlos Granados, Rakesh Kumar, Venkatesh Rangarajan, Akram Al-Ibraheem, Mukbil Hourani, Nor S Ali, Azra Ahmad, Zohar Keidar, Ozlem Kucuk, Umut Elboga, Mateos Bogoni, Diana Paez
Quanta Diagnostico e Terapia, Brazil., University of Bologna., Division of Human Health, International Atomic Energy Agency., Medical University of Warsaw., Clinical Hospital of the University of Uruguay., Instituto Nacional de Cancerologia, Mexico., Nuclear Medicine Department, National Centre of Oncology, Azerbaijan., University of Pretoria, South Africa., All India Institute of Medical Sciences, India., Tata Memorial Centre., King Hussein Cancer Center, Jordan., American University of Beirut; Medical Center, Lebanon., Institute Kanser Negara, Malaysia., Pakistan Atomic Energy Commission, Pakistan., Rambam Medical Centre, Israel., ankara university medical school, Turkey., University of Gaziantep, Turkey., Quanta, Brazil., International Atomic Energy Agency, Austria.