Testing advanced prostate MRI scans against tissue examination to detect significant prostate cancer
Compares advanced prostate MRI methods with tissue analysis in adult men suspected of prostate cancer.
Plain-language title generated from the registry record
Registry title: Detecting Clinically Significant Prostate Cancer With Advanced MRI Protocols and Extensive Histopathology
Key facts
- Where
- São Paulo, BrazilSee the site
Where in Brazil
- Instituto do Câncer do Estado de São PauloSão Paulo, BrazilTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Virdx, Inc.
- Trial code
- NCT07432360
- Record updated
- 25 February 2026
- Original description
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.Read full original descriptionShow less
Bridging Imaging and Pathology: Using Advanced MRI Protocols in Correlation With Extensive Histopathology to Detect Clinically Significant Prostate Cancer
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.
Inclusion: 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: 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.); Inability to give consent.