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

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT07432360

Enrollment

300

Registered

2026-02-25

Start date

2026-01-28

Completion date

2028-06-01

Last updated

2026-02-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prostate Cancer

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

MALE

Age

18 Years to No maximum

Healthy volunteers

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.).

Design outcomes

Primary

Measure	Time frame
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)

Countries

Brazil

Contacts

CONTACTSina Knapp, PhD

sina.knapp@virdx.com+4917680891277

PRINCIPAL_INVESTIGATORMarcelo Araujo Queiroz, MD PhD

Instituto do Câncer do Estado de São Paulo

Outcome results