NCT07432360Recruiting
Detecting Clinically Significant Prostate Cancer With Advanced MRI Protocols and Extensive Histopathology
Bridging Imaging and Pathology: Using Advanced MRI Protocols in Correlation With Extensive Histopathology to Detect Clinically Significant Prostate Cancer
Source: ClinicalTrials.gov · Last updated 25 Feb 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 300 (estimated)
- First submitted
- 17 Feb 2026
- Start date
- 28 Jan 2026
- Primary completion date
- Jun 2028
- Lead sponsor
- Virdx, Inc.
- Diseases
- Prostate cancer
- NCT number
- NCT07432360
What you commit to
- Study type: Observational
- Planned participants: 300
- From 28 Jan 2026 to the primary completion date, Jun 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.).
Other
- Inability to give consent.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: Male · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Instituto do Câncer do Estado de São Paulo Coordinator of this site? Confirm its status | São Paulo | Brazil | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.