NCT07432360 Detecting Clinically Significant Prostate Cancer With Advanced MRI Protocols and Extensive Histopathology
| NCT ID | NCT07432360 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Virdx, Inc. |
| Condition | Prostate Cancer |
| Study Type | OBSERVATIONAL |
| Enrollment | 300 participants |
| Start Date | 2026-01-28 |
| Primary Completion | 2028-06 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 300 participants in total. It began in 2026-01-28 with a primary completion date of 2028-06.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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.).
Contact & Investigator
Marcelo Araujo Queiroz, MD PhD
PRINCIPAL INVESTIGATOR
Instituto do Câncer do Estado de São Paulo
Frequently Asked Questions
Who can join the NCT07432360 clinical trial?
This trial is open to male participants only, aged 18 Years or older, studying Prostate Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07432360 currently recruiting?
Yes, NCT07432360 is actively recruiting participants. Contact the research team at sina.knapp@virdx.com for enrollment information.
Where is the NCT07432360 trial being conducted?
This trial is being conducted at São Paulo, Brazil.
Who is sponsoring the NCT07432360 clinical trial?
NCT07432360 is sponsored by Virdx, Inc.. The principal investigator is Marcelo Araujo Queiroz, MD PhD at Instituto do Câncer do Estado de São Paulo. The trial plans to enroll 300 participants.
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