Determining the diagnostic value of PSMA-PET/CT imaging in patients with persistent high prostate specific antigen levels and negative prostate biopsies.

Purpose: To assess the diagnostic performance of prostate specific membranous antigen (PSMA) positron emission tomography/computed tomography (PET/CT) imaging to localize primary prostate cancer (PCa) in men with persistent elevated prostate-specific antigen (PSA) levels and previous prostate biopsies that were negative for PCa.

Methods: In this study, 34 men with persistently elevated PSA-levels, previous negative for PCa biopsies and who subsequently underwent diagnostic PSMA-PET/CT imaging were retrospectively evaluated. Men were divided into 3 groups: 1. 12 men with a previous negative mpMRI scan (PI-RADS 1-2) 2. 17 men with a positive mpMRI scan (PI-RADS 3-5), but negative MRI-targeted biopsies and 3. Four men in whom mpMRI was contraindicated. If PSMA-avid lesions were seen, patients underwent 2-4 cognitive targeted biopsies in combination with systematic biopsies. The detection rate of PSMA-PET/CT for PCa, and the accuracy of (possible) targeted biopsies were calculated.

Results: Included men had a median PSA-level of 22.8 ng/mL (Interquartile Range 15.6-30.0) at the time of PSMA-PET/CT. Elevated PSMA-ligand uptake in the prostate suspicious for PCa was observed in 22/34 patients (64.7%). In 18/22 patients (54.5%), PSMA-targeted prostate biopsies were performed. In 3/18 patients (16.6%), the targeted biopsies showed International Society of Urological Pathology (ISUP) score 1-2 PCa. The other men had inflammation or benign findings after histopathological examination of the biopsy cores.

Conclusion: In this study, the clinical value of PSMA-PET/CT for patients with an elevated PSA-level, and negative for PCa biopsies was low. Only very few men were diagnosed with PCa, and no clinically significant PCa was found.