Multiparametric Magnetic Resonance Imaging (mpMRI) Versus Prostate-Specific Membrane Antigen Positron Emission Tomography (PSMA-PET) for Detecting Clinically Significant Prostate Cancer in Transition Zone Lesions /PRostate Imaging With MRI and PET in the Transition Zone (PRIME-TZ)

This prospective, single-center diagnostic accuracy study will compare mpMRI and PSMA-PET for the detection of clinically significant prostate cancer in patients with prostate imaging reporting and data System (PI-RADS) ≥4 lesions located in the transition zone of the prostate. All participants will undergo both mpMRI and 18F-PSMA-1007 PET before prostate biopsy. Imaging findings will be evaluated independently, and biopsy histopathology will serve as the reference standard for determining the presence of clinically significant prostate cancer. The primary objective is to compare the diagnostic performance of mpMRI and PSMA-PET for detecting clinically significant prostate cancer. The study will also evaluate agreement between the two imaging methods and explore whether combining mpMRI and PSMA-PET may improve diagnostic accuracy and help reduce unnecessary prostate biopsies.

Inclusion Criteria: * Men with suspected prostate cancer. * Candidates for prostate biopsy with a PI-RADS ≥4 lesion located in the - transition zone of the prostate identified on mpMRI. * Ability and willingness to provide written informed consent. Exclusion Criteria: * Previous treatment for prostate cancer, including surgery, radiotherapy, or hormonal therapy. * Concomitant conditions that preclude or substantially interfere with imaging evaluation, including severe renal impairment, untreated severe claustrophobia, or mpMRI-incompatible metallic implants. * Contraindication to mpMRI or PSMA-PET, including severe renal impairment, MRI-incompatible implants, severe untreated claustrophobia, or known hypersensitivity to gadolinium-based contrast agents or the PSMA radiotracer. * Patients undergoing active surveillance without an immediate indication for prostate biopsy.