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

NCT07432360 | Recruiting

• 1 other identifier: VIRDX 2025_BR
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

Brief Summary

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

Prostate Cancer

Outcome Measures

Primary Outcomes (1)

• Comparison of different microstructure models in the performance of detecting csPCa

  Upon study completion since data from all subjects need to be included (Until 6 months after the last patient got included)

Study Arms (1)

Patients with biopsy-proven PCa who are scheduled for RPE

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients at the Instituto do Câncer do Estado de São Paulo

You may qualify if:

• 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.

You may not qualify if:

• 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.).

Sponsors & Collaborators

• Virdx, Inc.: lead
• Instituto do Cancer do Estado de São Paulo: collaborator

Study Sites (1)

Instituto do Câncer do Estado de São Paulo

São Paulo, Brazil

RECRUITING

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 Officials

• Marcelo Araujo Queiroz, MD PhD

  Instituto do Câncer do Estado de São Paulo

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sina Knapp, PhD

CONTACT

+4917680891277; sina.knapp@virdx.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Day
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 17, 2026
• First Posted: February 25, 2026
• Study Start: January 28, 2026
• Primary Completion (Estimated): June 1, 2028
• Study Completion (Estimated): June 1, 2028
• Last Updated: February 25, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)