Ignite Creation Date:
2026-03-26 @ 3:16 PM
Ignite Modification Date:
2026-03-30 @ 12:19 AM
Study NCT ID:
NCT07485257
Status:
COMPLETED
Last Update Posted:
2026-03-20
First Post:
2025-12-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Molecular Profiling of MRI-PSMA PET Discordance in Prostate Cancer
Sponsor:
IRCCS San Raffaele
Organization:
Study Overview
Official Title:
Molecular Profiling of Prostate Cancer Lesions With MRI-PSMA PET Discordance
Status:
COMPLETED
Status Verified Date:
2026-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
MP-PET-MRI
Brief 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. 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.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: