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

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.

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Key information

Conditions

Prostate Cancer Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasms Neoplasms by Site Prostatic Diseases Prostatic Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

18 year and older

Sex eligibility

Male

Study type

Observational

Primary location

Instituto do Câncer do Estado de São Paulo

São Paulo, Brazil

Location status: Recruiting

Who can participate

Healthy volunteers accepted: No

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

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.).

Treatment and study plan

Primary outcomes

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)

Study contacts

Contact information is provided by the study sponsor or research team.

Sina Knapp, PhD

CONTACT

[email protected]

+4917680891277

Sponsors and collaborators

Lead sponsor

Virdx, Inc.

Industry

Collaborators

Instituto do Cancer do Estado de São Paulo

Registry information

Official study title

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

Important dates

Study start: 2026
Primary completion: 2028
Study completion: 2028
First posted: Feb 25, 2026
Registry last updated: Feb 25, 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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