NCT07432360

Recruiting

Detecting Clinically Significant Prostate Cancer With Advanc...

Virdx, Inc.Source

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Other study identifiers

Sponsor study identifier

VIRDX 2025_BR

Study Type

observational

Estimated enrollment

300

Locations

1 country

Sites

1

Timeline

Study Start

January 28, 2026

Actual (reported)

Primary Completion

June 2028

Estimated

Planned date reported by the registry; this milestone is not confirmed as achieved.

Study Completion

June 2028

Estimated

Planned date reported by the registry; this milestone is not confirmed as achieved.

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.

Registry Overview

Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.

Recruitment status: recruiting
Estimated enrollment: 300 participants
Study completion date: June 2028
Estimated
Planned date reported by the registry; this milestone is not confirmed as achieved.
Listed locations: 1 countries · 1 sites

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.

Study Start
January 28, 2026
Actual (reported)
First Submitted
February 17, 2026
Actual (reported)
First Posted
February 25, 2026
Actual (reported)
Primary Completion
June 2028
Estimated
Planned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
June 2028
Estimated
Planned date reported by the registry; this milestone is not confirmed as achieved.

Last Updated: February 25, 2026
Status Verified: February 2026
Last Update Submitted: February 24, 2026

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

Age18 Years+

Sexmale

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

Sampling MethodNon-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.

Sponsors & Collaborators

Virdx, Inc.
Industrylead
Instituto do Cancer do Estado de São Paulo
Othercollaborator

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, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale 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

Actual (reported)

Primary Completion

June 2028

Estimated

Planned date reported by the registry; this milestone is not confirmed as achieved.

NCT07422597

Prostate Risk Or Radiology Assessment Non-inferiority Design, Upfront MRI or Risk Calculator in Men With Suspected Prostate Cancer

Not ApplicableRecruiting

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Prostate Cancer Early Detection Using Serial MRI Examinations

Not ApplicableNot Yet Recruiting

NCT07468396

A Phase I Clinical Study of GLR2037 in Patients With Advanced Prostate Cancer

Phase 1Not Yet Recruiting

NCT07892378

Multiparametric Magnetic Resonance Imaging (mpMRI) Versus Prostate-Specific Membrane Antigen Positron Emission Tomography (PSMA-PET) for Detecting Clinically Significant Prostate Cancer in Transition Zone Lesions /PRostate Imaging With MRI and PET in the Transition Zone (PRIME-TZ)

Not Yet Recruiting

NCT07875491

Artificial Intelligence Software (Prostate Intelligence) for Detecting Clinically Significant Prostate Cancer on MRI

Not ApplicableNot Yet Recruiting

NCT07184970

PRISM Study: Prostate Recurrence Detection Using Imaging With PSMA PET/MRI Post-high Intensity Focused Ultrasound

Recruiting

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.).

Contact the study team to confirm eligibility.

Study Completion

June 2028

Estimated

Planned date reported by the registry; this milestone is not confirmed as achieved.

Last Updated

February 25, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing: Will not share

Source record

Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.

Source: ClinicalTrials.gov.

JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.

Registry identifier: NCT07432360
Data provider: ClinicalTrials.gov
Source updated: 2026-02-25
Normalization version: ctgov-legacy-1

Open registry record

Source retrieved: 2026-10-25 22:32:17 UTC

Locations

BR(1)

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Study Arms (1)

Patients with biopsy-proven PCa who are scheduled for RPE

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Central Study Contacts

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations