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Completed

NCT Number: NCT07485257

Molecular Profiling of MRI-PSMA PET Discordance in Prostate Cancer

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.

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Key information

Conditions

Prostate Cancer Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Molecular Imaging Neoplasms Neoplasms by Site PSMA PET/CT Prostatic Diseases Prostatic Neoplasms RNA Transcriptomics Urogenital Diseases Urogenital Neoplasms

Age range

18 year and older

Sex eligibility

Male

Study type

Observational

Primary location

IRCCS San Raffaele

Milan, 20132, Italy

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Low quality samples availability

Treatment and study plan

Primary outcomes

  1. Number of omic features in MRI-PSMA PET discordant versus concordant lesions

    Time frame: At the time of biopsy

  2. Number of molecular features in MRI-PSMA PET discordant versus concordant lesions

    Time frame: At the time of biopsy

Sponsors and collaborators

Lead sponsor

IRCCS San Raffaele

Other

Registry information

Official study title

Molecular Profiling of Prostate Cancer Lesions With MRI-PSMA PET Discordance

Acronym: MP-PET-MRI

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Mar 20, 2026
Registry last updated
May 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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