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)

NCT07892378 | Not Yet Recruiting

• 1 other identifier: 2043
• Study Type: observational
• Target: 65
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Prostate Cancer

Keywords

Prostate Cancer; Clinically Significant Prostate Cancer; PSMA-PET; 18F-PSMA-1007; Multiparametric MRI; mpMRI; PI-RADS; Transition Zone; Prostate Biopsy; PRIMARY Score; Diagnostic Accuracy

Outcome Measures

Primary Outcomes (1)

• Diagnostic Accuracy of mpMRI and 18F-PSMA-1007 PET for Clinically Significant Prostate Cancer

  Diagnostic performance of mpMRI and 18F-PSMA-1007 PET for the detection of clinically significant prostate cancer in PI-RADS ≥4 transition zone lesions will be assessed using prostate biopsy histopathology as the reference standard. Clinically significant prostate cancer will be defined as Gleason score ≥7. Sensitivity, specificity, and area under the receiver operating characteristic curve (AUC) will be calculated for each imaging modality and compared between modalities.

  From completion of diagnostic imaging to availability of prostate biopsy histopathology results, up to 30 days.

Secondary Outcomes (1)

• Agreement Between mpMRI and 18F-PSMA-1007 PET

  From the first imaging examination to completion of both mpMRI and 18F-PSMA-1007 PET assessments, up to 14 days.

Study Arms (1)

Patients With PI-RADS ≥4 Transition Zone Lesions

Men with suspected prostate cancer and a PI-RADS ≥4 lesion located in the transition zone of the prostate on mpMRI. All participants will undergo Fluorine-18 Prostate-Specific Membrane Antigen-1007 Positron Emission Tomography (18F-PSMA-1007 PET) in addition to mpMRI before prostate biopsy. Imaging findings will be evaluated independently. All participants will subsequently undergo image-guided prostate biopsy, including targeted and systematic sampling, with histopathology serving as the reference standard for the detection of clinically significant prostate cancer.

Diagnostic Test: Multiparametric Magnetic Resonance Imaging (mpMRI); Diagnostic Test: 18F-PSMA-1007 PET; Procedure: Prostate Biopsy

Interventions

Multiparametric Magnetic Resonance Imaging (mpMRI) DIAGNOSTIC_TEST

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.

Patients With PI-RADS ≥4 Transition Zone Lesions

18F-PSMA-1007 PET DIAGNOSTIC_TEST

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.

Patients With PI-RADS ≥4 Transition Zone Lesions

Prostate Biopsy PROCEDURE

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.

Patients With PI-RADS ≥4 Transition Zone Lesions

Eligibility Criteria

• Sex: male
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult men with suspected prostate cancer who are candidates for prostate biopsy and have a PI-RADS ≥4 lesion located in the transition zone of the prostate on mpMRI will be prospectively enrolled at a single center. Eligible patients will be consecutively recruited until the prespecified target enrollment of 65 participants is reached. All participants will undergo mpMRI and 18F-PSMA-1007 PET before image-guided prostate biopsy. Histopathological examination of targeted and systematic biopsy samples will serve as the reference standard for determining the presence of clinically significant prostate cancer. The target sample size was determined a priori based on the paired diagnostic study design, with allowance for potential losses, technical failures, exclusions, or incomplete data.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sanatorio Privado San Geronimo: lead

Study Sites (1)

Sanatorio San Geronimo

Santa Fe, Santa Fe Province, 3000, Argentina

Location

Related Publications (6)

• Oto A, Kayhan A, Jiang Y, Tretiakova M, Yang C, Antic T, Dahi F, Shalhav AL, Karczmar G, Stadler WM. Prostate cancer: differentiation of central gland cancer from benign prostatic hyperplasia by using diffusion-weighted and dynamic contrast-enhanced MR imaging. Radiology. 2010 Dec;257(3):715-23. doi: 10.1148/radiol.10100021. Epub 2010 Sep 15.

  PMID: 20843992 RESULT

• de Rooij M, Hamoen EH, Futterer JJ, Barentsz JO, Rovers MM. Accuracy of multiparametric MRI for prostate cancer detection: a meta-analysis. AJR Am J Roentgenol. 2014 Feb;202(2):343-51. doi: 10.2214/AJR.13.11046.

  PMID: 24450675 RESULT

• Chesnais AL, Niaf E, Bratan F, Mege-Lechevallier F, Roche S, Rabilloud M, Colombel M, Rouviere O. Differentiation of transitional zone prostate cancer from benign hyperplasia nodules: evaluation of discriminant criteria at multiparametric MRI. Clin Radiol. 2013 Jun;68(6):e323-30. doi: 10.1016/j.crad.2013.01.018. Epub 2013 Mar 23.

  PMID: 23528164 RESULT

• Hoeks CM, Hambrock T, Yakar D, Hulsbergen-van de Kaa CA, Feuth T, Witjes JA, Futterer JJ, Barentsz JO. Transition zone prostate cancer: detection and localization with 3-T multiparametric MR imaging. Radiology. 2013 Jan;266(1):207-17. doi: 10.1148/radiol.12120281. Epub 2012 Nov 9.

  PMID: 23143029 RESULT

• Satapathy S, Singh H, Kumar R, Mittal BR. Diagnostic Accuracy of 68Ga-PSMA PET/CT for Initial Detection in Patients With Suspected Prostate Cancer: A Systematic Review and Meta-Analysis. AJR Am J Roentgenol. 2021 Mar;216(3):599-607. doi: 10.2214/AJR.20.23912. Epub 2021 Jan 21.

  PMID: 32755196 RESULT

• Emmett L, Buteau J, Papa N, Moon D, Thompson J, Roberts MJ, Rasiah K, Pattison DA, Yaxley J, Thomas P, Hutton AC, Agrawal S, Amin A, Blazevski A, Chalasani V, Ho B, Nguyen A, Liu V, Lee J, Sheehan-Dare G, Kooner R, Coughlin G, Chan L, Cusick T, Namdarian B, Kapoor J, Alghazo O, Woo HH, Lawrentschuk N, Murphy D, Hofman MS, Stricker P. The Additive Diagnostic Value of Prostate-specific Membrane Antigen Positron Emission Tomography Computed Tomography to Multiparametric Magnetic Resonance Imaging Triage in the Diagnosis of Prostate Cancer (PRIMARY): A Prospective Multicentre Study. Eur Urol. 2021 Dec;80(6):682-689. doi: 10.1016/j.eururo.2021.08.002. Epub 2021 Aug 28.

  PMID: 34465492 RESULT

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Multiparametric Magnetic Resonance Imaging

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Magnetic Resonance Imaging; Tomography; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• Miguel A Bergero, MD, MSc, PhD

  Sanatorio San Geronimo

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Miguel A Bergero, PhD

CONTACT

+54 9 342 4099960; angelbergero@hotmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 22, 2026
• First Posted: October 23, 2026
• Study Start (Estimated): November 1, 2026
• Primary Completion (Estimated): November 1, 2028
• Study Completion (Estimated): March 1, 2029
• Last Updated: October 23, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

AR (1)