Prostate CancerPRIME-TZNCT07892378
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)
An observational study of Prostate Cancer, run by Sanatorio Privado San Geronimo at 1 site in Argentina.
Trial 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. Read more about this study
- Who is it for?
- Any age, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- Multiparametric Magnetic Resonance Imaging (mpMRI), 18F-PSMA-1007 PET and Prostate Biopsy
- Type of treatment
- Injection or infusion, Surgery or procedure
- How many people
- 65 participants
- Where
- 1 siteArgentina
- Study dates
- 1 Nov 2026to 1 Mar 2029
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Men only
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
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
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
- Being tested
- Multiparametric Magnetic Resonance Imaging (mpMRI), 18F-PSMA-1007 PET, Prostate Biopsy
- 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
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
18F-PSMA-1007 PETDiagnostic 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.
Prostate BiopsyProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Diagnostic Test: Multiparametric Magnetic Resonance Imaging (mpMRI); Diagnostic Test: 18F-PSMA-1007 PET; Procedure: Prostate Biopsy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Agreement between mpMRI and 18F-PSMA-1007 PET for the identification of suspicious prostate lesions will be assessed using Cohen's kappa coefficient.
Measured: From the first imaging examination to completion of both mpMRI and 18F-PSMA-1007 PET assessments, up to 14 days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2026
- Study start1 Nov 2026 (estimated)
- Primary completion1 Nov 2028 (estimated)
- Study completion1 Mar 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 65 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sanatorio Privado San Geronimo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Miguel Angel Bergero, Sanatorio Privado San Geronimo
- Investigators
- Miguel A Bergero, MD, MSc, PhD, Principal investigator, Sanatorio San Geronimo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07892378
- Sponsor's protocol ID
- 2043
- Acronym
- PRIME-TZ
- Status last verified
- Sep 2026
- First submitted
- 22 Sep 2026
- Last updated
- 23 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data (IPD) will not be publicly shared due to participant confidentiality and data protection considerations. Study results will be reported in aggregate form in scientific publications and presentations.
Publications
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.
PubMed 20843992de 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.
PubMed 24450675Chesnais 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.
PubMed 23528164Hoeks 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.
PubMed 23143029Satapathy 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.
PubMed 32755196Emmett 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.
PubMed 34465492