Positron Emission Tomography / Magnetic Resonance Imaging (PET/MRI) Guided Biopsy in Men With Elevated PSA

In this open label, single center, non-randomized, diagnostic study we plan to include 40 men with elevated PSA (ages 30-50 PSA \>2.5 ng/mL; ages 50-80 PSA \> 4ng/mL), which are assigned to a MRI guided biopsy. These patients will undergo one additional PET/MRI scan with \[68Ga\]PSMA within two to three weeks before the biopsy (Arm A), or in case of an unclear/negative MRI scan but positive biopsy two to three weeks after biopsy (Arm B). In Arm A a radiologist will delineate the suspected areas on (A) multiparametric magnetic resonance image (mpMRI) and a nuclear medicine physician will delineate and color code the suspicious areas on the PET/MRI: (B) \[68Ga\]PSMA. The images will be loaded into the BiopSee® system. Lesions positive on both modalities will be labeled as "AB". Every suspicious lesion will be targeted with 3 cores. A maximum of 3 targets will be selected per patient. For arm B: PET/MRI results will be correlated with the template biopsy results. The data analysis of Arm A and Arm B will be identical. For the analysis the Gleason score from the histology of the core biopsies will serve as standard of truth. After completion of the PET/MR study part - an amendment for PET/CT was submitted to the local ethics commity and acknowledged to include 10 more participants with PSMA PET/CT to investigate the use of PET/CT guided biopsy and intraoperative verivication of the target with a gamma counter.