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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)
Sponsor: Sanatorio Privado San Geronimo
Summary
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.
Official title: Comparison of Multiparametric Magnetic Resonance Imaging (mpMRI) Versus Prostate-Specific Membrane Antigen Positron Emission Tomography (PSMA-PET) for the Evaluation of Prostate Imaging Reporting and Data System (PI-RADS) ≥4 Lesions in the Prostate Transition Zone: A Prospective Clinical Study
Key Details
Gender
MALE
Age Range
Any - Any
Study Type
OBSERVATIONAL
Enrollment
65
Start Date
2026-11-01
Completion Date
2029-03-01
Last Updated
2026-10-23
Healthy Volunteers
No
Conditions
Interventions
Multiparametric Magnetic Resonance Imaging (mpMRI)
mpMRI of the prostate will be performed using a 1.5- to 3-Tesla MRI system without an endorectal coil. The protocol will include T2-weighted imaging, diffusion-weighted imaging (DWI), and dynamic contrast-enhanced MRI (DCE-MRI). Lesions located in the transition zone will be evaluated according to the PI-RADS classification. MRI images will be interpreted independently and blinded to the PSMA-PET findings.
18F-PSMA-1007 PET
Participants will undergo PSMA-PET using 18F-PSMA-1007 administered at a dose of 2 MBq/kg. PET images will be acquired approximately 60 minutes after tracer injection. Intraprostatic lesions will be evaluated using the PRIMARY Score according to the PROMISE V2 framework, based on the pattern and intensity of PSMA uptake relative to reference organs. PRIMARY Scores 1-2 will be considered negative and scores 3-5 positive. Maximum standardized uptake value (SUVmax) will also be recorded for transition zone lesions. PSMA-PET images will be interpreted independently and blinded to the mpMRI findings.
Prostate Biopsy
Participants will undergo image-guided prostate biopsy. Targeted samples from suspicious lesions and systematic biopsy samples will be obtained. Histopathological examination of biopsy specimens will serve as the reference standard for determining the presence of clinically significant prostate cancer.
Locations (1)
Sanatorio San Geronimo
Santa Fe, Santa Fe Province, Argentina