Higher diagnostic accuracy of 64Cu PET/CT compared to standard 18F-choline PET/CT in the detection rate of metastasis from prostate cancer.

Prostate cancer at risk of developing metastatic lesions

To evaluate the diagnostic performance in terms of sensitivity and specificity of 64Cu PET/CT versus 18F-choline PET/CT on a patient basis, in relation to the whole individual. In particular, 18F-choline PET/CT and 64CuCl2 PET/CT will be evaluated as positive (PET+) in case of evidence of pathological focal uptake in correspondence with site(s) compatible with metastases (bone, lymph node and visceral;otherwise they will be judged negative (PET-) when no pathological focal uptakes are detectable

The diagnostic accuracy of the two PET/CT (64Cu and 18F-choline) will be assessed by area under the ROC curve (AUC) and the difference in the curve between the two methods will be evaluated., Sensitivity and specificity on a lesion-based and region-based basis will be analysed by aggregation according to body region (chest, abdomen, pelvis) and anatomo-pathological character of the lesions (bone, lymph node, visceral)., The sensitivity 64Cu PET and 18F-choline will be correlated with PSA levels and calculated as for the primary objective., Patients will be classified into non-metastatic, oligometastatic and multimetastatic with both PET/CT. (A patient with up to three metastases will be defined as oligometastatic)., In each patient the different impact of the two PET scans on decision-making (impact of the test versus pre-test probability) will be assessed with calculation of positive and negative predictive values., In each patient the impact determined by the 64Cu PET/CT on clinical outcome will be evaluated by means of the patient's follow-up data and in particular the consequences of misdiagnosis (delay of treatment or unnecessary intervention) will be assessed., The inter-observer reproducibility of 64CuCl2 and 18F-FCH PET/CT will be evaluated.

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