Detecting Clinically Significant Prostate Cancer With Advanced MRI Protocols and Extensive Histopathology
Recruiting · NCT07432360 · Observational (researchers observe without assigning treatment) · Lead sponsor: Virdx, Inc.
View the official record on ClinicalTrials.gov →What this trial is about
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.
Who can take part
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.).
Where it is running
1 location listed.
- Instituto do Câncer do Estado de São Paulo - São Paulo, Brazil