Actively Recruiting

Age: 18Years +
MALE
NCT07432360

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

Led by Virdx, Inc. · Updated on 2026-02-25

300

Participants Needed

1

Research Sites

122 weeks

Total Duration

On this page

Sponsors

V

Virdx, Inc.

Lead Sponsor

I

Instituto do Cancer do Estado de São Paulo

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
MALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Humans with a prostate 18 years of age or older
  • Biopsy-proven prostate cancer patients scheduled for radical prostatectomy
  • Signed informed consent confirming understanding of the study purpose and procedures
  • Willingness, ability, and legal capacity to participate in the study
  • Ability to follow the prohibitions and restrictions defined in the protocol
Not Eligible

You will not qualify if you...

  • Inability to give consent
  • Prior hormone treatment such as androgen deprivation therapy or 5-alpha-reductase inhibitors
  • Previous prostate cancer treatment
  • Previous transurethral resection of the prostate or other prostate surgery
  • Prior total hip replacement or metal implants interfering with MRI of the hip region
  • General contraindications for MRI including pacemaker or relevant metal implants

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Instituto do Câncer do Estado de São Paulo

São Paulo, Brazil

Actively Recruiting

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Research Team

S

Sina Knapp, PhD

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

1

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