Re: James P. Buteau, Daniel Moon, Michael T. Fahey, et al. Clinical Trial Protocol for PRIMARY2: A Multicentre, Phase 3, Randomised Controlled Trial Investigating the Additive Diagnostic Value of [68Ga]Ga-PSMA-11 Positron Emission Tomography/Computed Tomography in Men with Negative or Equivocal Multiparametric Magnetic Resonance Imaging for the Diagnosis of Clinically Significant Prostate Cancer. Eur Urol Oncol. In press. https://doi.org/10.1016/j.euo.2023.11.008

We read with great interest the protocol for the clinical trial developed by Buteau et al [1] to demonstrate noninferiority of [68Ga]Ga-PSMA-11 positron emission tomography/computed tomography (PET/CT) in comparison to systematic transperineal prostate biopsy in detecting clinically significant prostate cancer (csPC) in men with negative or equivocal multiparametric magnetic resonance imaging (mpMRI) results. This is a challenging task because this next-generation imaging (NGI) technique, which was first standardized by the RADAR III group [2], is not yet widespread enough to allow systematic use.