An observational study in Prostate Cancer, sponsored by Sanatorio Privado San Geronimo. Not yet recruiting at 1 site in Argentina. Open to male participants. Per ClinicalTrials.gov, last updated 2026-10-23.
Sponsored by Sanatorio Privado San Geronimo · Observational
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.
6,484 studies on the registry are indexed under Prostatic Neoplasms; 1,415 are open to participants now.
This study's planned enrollment of 65 is below the median of 200 across 1,200 observational studies indexed under Prostatic Neoplasms.
Browse Prostatic Neoplasms studies →This is the only study on the registry with Sanatorio Privado San Geronimo as lead sponsor.
Counted across the registry records on this site, refreshed daily.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
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
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.
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.
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.
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.
Time frame: From completion of diagnostic imaging to availability of prostate biopsy histopathology results, up to 30 days.
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.
Time frame: From the first imaging examination to completion of both mpMRI and 18F-PSMA-1007 PET assessments, up to 14 days.
Plan to share: 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.
Start is estimated for Nov 2026; primary completion for Nov 2028, 24 months later.
Of 496 non-industry observational studies under Prostatic Neoplasms, half reached primary completion within 66 months of starting (the median), counting those still running; a quarter within 29 and three quarters within 147. This study's planned 24 months is below that.
Counting every sponsor, half of 584 studies reached it within 60 months; a quarter within 29 and three quarters within 135.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.