Prostate CancerMP-PET-MRINCT07485257
Molecular Profiling of MRI-PSMA PET Discordance in Prostate Cancer
An observational study of Prostate Cancer and Molecular Imaging, run by IRCCS San Raffaele at 1 site in Italy.
Trial summary
MRI and PSMA-PET are highly sensitive imaging tools for prostate cancer, yet they often detect different lesions. These discordant findings pose clinical uncertainty because their biological significance is unclear. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer, Molecular Imaging, Transcriptomics
- How many people
- 30 participants
- Where
- 1 siteItaly
- Study dates
- 4 Dec 2023to 9 Dec 2025
- 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 18 years and older
- Men only
- Adult, Older adult
Study population: The study population consists of male patients with a histologically confirmed diagnosis of prostate cancer who previously underwent both multiparametric MRI and PSMA-PET imaging at our institution. All participants have provided informed consent for inclusion in our institutional biobank, from which archived tissue samples will be selected. Eligible samples must be of sufficient quality for molecular analyses. Patients are retrospectively identified from existing biobank material; no new patient enrollment or prospective procedures are required
Who may be able to join
- Signed informed consent
- PCa diagnosis
- Available samples
- Performed both PSMA PET and MRI
Who cannot join
- Low quality samples availability
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Molecular Profiling of Prostate Cancer Lesions With MRI-PSMA PET Discordance
MRI and PSMA-PET are highly sensitive imaging tools for prostate cancer, yet they often detect different lesions. These discordant findings pose clinical uncertainty because their biological significance is unclear. This project aims to molecularly characterize MRI-PSMA PET discordant lesions using high-quality biobanked samples from patients enrolled in an institutional study (NCT06187870). By integrating imaging and molecular data, the study will clarify whether these lesions represent indolent disease, aggressive subclones, or biologically distinct entities, and will assess their clinical implications.
Read the detailed description
Magnetic Resonance Imaging and PSMA-PET are currently the most sensitive imaging modalities for prostate cancer, yet they do not always provide concordant results. Discordant lesions, those detected by one modality but not the other, represent a significant clinical challenge, as their biological nature and implications remain poorly understood. A molecular characterization of these lesions may clarify whether they correspond to indolent clones missed due to imaging limitations, aggressive subclones with distinct molecular features, or biologically different disease entities. We aim to investigate prostate cancer lesions that are discordant between MRI and PSMA-PET, with the specific objective of elucidating their molecular characteristics and clinical implications. Molecular omic analyses will be performed on existing biobank samples from patients enrolled at our institution who have already provided informed consent for research use. This resource provides access to high-quality biospecimens linked with imaging data, enabling a comprehensive evaluation of MRI-PSMA PET discordant prostate cancer lesions.
- Conditions
- Prostate Cancer, Molecular Imaging, Transcriptomics, RNA, PSMA PET/CT
- Medical subject headings
- Prostatic Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of omic features in MRI-PSMA PET discordant versus concordant lesions
Measured: At the time of biopsy
Number of molecular features in MRI-PSMA PET discordant versus concordant lesions
Measured: At the time of biopsy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2026
- Study start4 Dec 2023
- Primary completion9 Dec 2025
- Study completion9 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Retrospective
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- IRCCS San Raffaele
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prof. Alberto Briganti, IRCCS San Raffaele
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07485257
- Sponsor's protocol ID
- MP-PET-MRI
- Acronym
- MP-PET-MRI
- Status last verified
- May 2026
- First submitted
- 10 Dec 2025
- Last updated
- 15 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No