Diagnostic Performance and Clinical Impact of 68 Ga-PSMA-11 PET/CT Imaging in Early Relapsed Prostate Cancer After Radical Therapy: A Prospective Multicenter Study (IAEA-PSMA Study)

The Journal of Nuclear Medicine

article

Juliano J. Cerci¹  Stefano Fanti²  Enrique E. Lobato³  Jolanta Kunikowska⁴  Omar Alonso⁵  Sevastian Medina⁶  Fuad Novruzov⁷  Thabo Lengana⁸  Carlos Granados⁶  Rakesh Kumar⁹  Venkatesh Rangarajan^1,10  Akram Al-Ibraheem^1,11  Mukbil Hourani^1,12  Nor S. Ali^1,13  Azra Ahmad^1,14  Zohar Keidar^1,15  Ozlem Küçük^1,16  Umut Elboga^1,17  Mateos Bogoni¹  Diana Paez³ 

[1] Quanta Diagnóstico e Terapia;IRCCS Azienda Ospedaliero-Universitaria di Bologna;Division of Human Health, International Atomic Energy Agency;Nuclear Medicine Department, Medical University of Warsaw;Centro Uruguayo de Imagenología Molecular;Instituto Nacional de Cancerologia;Nuclear Medicine Department, National Centre of Oncology;University of Pretoria;All India Institute of Medical Sciences;Tata Memorial Centre;King Hussein Cancer Center;American University of Beirut Medical Center;Institute Kanser Negara;Pakistan Atomic Energy Commission;Rambam Medical Centre;Ankara University;University of Gaziantep

关键词: PSMA;    PET/CT;    prostate cancer;    biochemical relapse;   

DOI  :  10.2967/jnumed.120.261886

学科分类：医学（综合）

来源: Society of Nuclear Medicine

【 摘 要 】

Biochemical recurrence (BCR) is a clinical challenge in prostate cancer (PCa) patients, as recurrence localization guides subsequent therapies. The use of PET with prostate-specific membrane antigen (PSMA) provides better accuracy than conventional imaging practice. This prospective, multicenter, international study was performed to evaluate the diagnostic performance and clinical impact of PSMA PET/CT for evaluating BCR in PCa patients in a worldwide scenario. Methods: Patients were recruited from 17 centers in 15 countries. Inclusion criteria were histopathologically proven prostate adenocarcinoma, previous primary treatment, clinically established BCR, and negative conventional imaging (CT plus bone scintigraphy) and MRI results for patients with PSA levels of 4–10 ng/mL. All patients underwent PET/CT scanning with 68Ga-PSMA-11. Images and data were centrally reviewed. Multivariate logistic regression analysis was applied to identify the independent predictors of PSMA-positive results. Variables were selected for this regression model on the basis of significant associations in the univariate analysis and previous clinical knowledge: Gleason score, the PSA level at the time of the PET scan, PSA doubling time, and primary treatment strategy. All patients were monitored for a minimum of 6 mo. Results: From a total of 1,004 patients, 77.7% were treated initially with radical prostatectomy and 22.3% were treated with radiotherapy. Overall, 65.1% had positive PSMA PET/CT results. PSMA PET/CT positivity was correlated with the Gleason score, PSA level at the time of the PET scan, PSA doubling time, and radiotherapy as the primary treatment (P < 0.001). Treatment was modified on the basis of PSMA PET/CT results in 56.8% of patients. PSMA PET/CT positivity rates were consistent and not statistically different among countries with different incomes. Conclusion: This multicenter, international, prospective trial of PSMA PET/CT confirmed its capability for detecting local and metastatic recurrence in most PCa patients in the setting of BCR. PSMA PET/CT positivity was correlated with the Gleason score, PSA level at the time of the PET scan, PSA doubling time, and radiotherapy as the primary treatment. PSMA PET/CT results led to changes in therapeutic management in more than half of the cohort. The study demonstrated the reliability and worldwide feasibility of PSMA PET/CT in the workup of PCa patients with BCR.

【 授权许可】

CC BY