Molecular Profiling of MRI-PSMA PET Discordance in Prostate Cancer

NCT07485257 | Completed

• 1 other identifier: MP-PET-MRI
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Prostate Cancer; Molecular Imaging; Transcriptomics; RNA; PSMA PET/CT

Outcome Measures

Primary Outcomes (2)

• Identification of omic alterations distinguishing MRI-PSMA PET discordant lesions from concordant lesions within the same cohort.

  At the time of biopsy

• Distribution of molecular profiles across discordant versus concordant lesions.

  At the time of biopsy

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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

You may qualify if:

• Signed informed consent
• PCa diagnosis
• Available samples
• Performed both PSMA PET and MRI

You may not qualify if:

• Low quality samples availability

Sponsors & Collaborators

• IRCCS San Raffaele: lead

Study Sites (1)

IRCCS San Raffaele

Milan, Milan, 20132, Italy

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Full professor

Study Record Dates

• First Submitted: December 10, 2025
• First Posted: March 20, 2026
• Study Start: December 4, 2023
• Primary Completion: December 9, 2025
• Study Completion: December 9, 2025
• Last Updated: March 20, 2026

Record last verified: 2026-03

Locations

IT (1)