NCT07892378Not yet recruiting
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)
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
Source: ClinicalTrials.gov · Last updated 23 Oct 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Observational
- Enrollment
- 65 (estimated)
- First submitted
- 22 Sept 2026
- Start date
- 1 Nov 2026
- Primary completion date
- 1 Nov 2028
- Lead sponsor
- Sanatorio Privado San Geronimo
- Diseases
- Prostate cancer, Childhood cancers
- NCT number
- NCT07892378
What you commit to
- Study type: Observational
- Planned participants: 65
- From 1 Nov 2026 to the primary completion date, 1 Nov 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
Other illness
- 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.
Other
- Patients undergoing active surveillance without an immediate indication for prostate biopsy.
Who the study is looking for
- 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.
Sex: Male · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Sanatorio San Geronimo Coordinator of this site? Confirm its status | Santa Fe | Argentina | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.