Prostate Cancer Clinical Trial
Official title:
Single-center Study for Biopsy Guidance Using Gallium-68 Labeled Prostate-specific Membrane Antigen (PSMA) PET/MRI in Patients With Elevated PSA Eligible for Prostate Biopsy in Comparison to Multiparametric MRI.
In 22% of patients with elevated Prostate-specific antigen (PSA) MRI guided biopsy will not detect significant prostate cancer (PCA) (defined as either: Gleason score (GS) ≥ 3+4 or tertiary pattern 5, or final stage ≥ pT3a and/or pN1). Therefore this study evaluates the ability of [68Ga]PSMA PET/MRI to detect and localize significant primary PCA to accurately direct prostate needle biopsy using the Gleason score from the histology of the core biopsies as standard of truth.
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.
