Detecting Clinically Significant Prostate Cancer With Advanced MRI Protocols and Extensive Histopathology

February 24, 2026 updated by: Virdx, Inc.

Bridging Imaging and Pathology: Using Advanced MRI Protocols in Correlation With Extensive Histopathology to Detect Clinically Significant Prostate Cancer

In recent years, new and promising approaches have emerged in the field of MRI imaging of the prostate. These approaches usually aim to visualise the so-called "microstructures" of the tissue and are intended to offer greater accuracy in the diagnosis of prostate cancer than the current mpMRI examination. To this end, mathematical microstructure models are calculated that determine the proportional presence of histological substructures in specific MRI volumes. Additional new MRI sequences that are not routinely recorded are required to calculate the microstructure models. In order to further investigate the possibilities of these new MRI sequences, this study will compare different mathematical models. In addition, a histopathological examination of the tissue will be performed.

Study Overview

Status

Recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

300

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Brazil
      • São Paulo, Brazil
        • Recruiting
        • Instituto do Cancer do Estado de São Paulo

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients at the Instituto do Câncer do Estado de São Paulo

Description

Inclusion Criteria:

  • Humans with a prostate ≥18 years of age.
  • Patients with biopsy-proven PCa who are scheduled for an RPE.
  • Signed informed consent form (ICF) that demonstrates study participant understands the purpose of and procedures necessary for the study.
  • Willingness, ability, and legal capacity to participate in the study.
  • Ability to adhere to the prohibitions and restrictions defined in this protocol.

Exclusion Criteria:

  • Inability to give consent.
  • Prior hormone treatment (i.e., androgen deprivation treatment (ADT) and/or 5-ɑ-reductase inhibitors).
  • Prior PCa treatment.
  • Prior transurethral resection of the prostate (TUR-P) or other prostate surgery.
  • Prior total hip arthroplasty on one or both sides or other metal implants that interfere with the MRI acquisition of the hip region.
  • General contraindications for an MRI scan (i.e., pacemaker, relevant metal implants, etc.).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Patients with biopsy-proven PCa who are scheduled for RPE

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Comparison of different microstructure models in the performance of detecting csPCa
Time Frame: Upon study completion since data from all subjects need to be included (Until 6 months after the last patient got included)
Upon study completion since data from all subjects need to be included (Until 6 months after the last patient got included)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Virdx, Inc.

Collaborators

Instituto do Cancer do Estado de São Paulo

Investigators

  • Principal Investigator: Marcelo Araujo Queiroz, MD PhD, Instituto do Cancer do Estado de São Paulo

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 28, 2026

Primary Completion (Estimated)

June 1, 2028

Study Completion (Estimated)

June 1, 2028

Study Registration Dates

First Submitted

February 17, 2026

First Submitted That Met QC Criteria

February 24, 2026

First Posted (Actual)

February 25, 2026

Study Record Updates

Last Update Posted (Actual)

February 25, 2026

Last Update Submitted That Met QC Criteria

February 24, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • VIRDX 2025_BR

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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