Diagnostic Accuracy of 68Ga-PSMA-11 PET/CT and Conventional Imaging for Initial Staging of Intermediate and High-risk Prostate Cancer Patients (the PROCA Study)

PSMA PET/CT is a promising method for primary lymph node staging in prostate cancer patients. However, there is lack of enough evidence related to studies with histopathology as a gold standard.
Cross-sectional anatomical imaging has been recommended for patients with unfavourable intermediate and high-risk prostate cancer for primary lymph node staging across urological guidelines despite known insufficient diagnostic accuracy for both CT and MRI.
The use of PSMA PET/CT has been evaluated in numerous settings, including primary staging and biochemical recurrence. Some studies have showed good clinical diagnostic performance in those patients where primary lymph node staging is indicated (high-risk and unfavourable intermediate-risk categories), even though some variations in diagnostic accuracy were observed across the trials. However, most studies were very heterogenous, mainly retrospective and of modest size.
Thus, this CRP will focus on the development of a phase 3, prospective, randomised, and multicentre international study to compare the diagnostic accuracy of PSMA-PET/CT and conventional imaging (CI) with post-prostatectomy histology as gold standard.