Clinical trial · Observational
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
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (1)
- label
- Patients with biopsy-proven PCa who are scheduled for RPE
Primary outcomes (1)
- measure
- Comparison of different microstructure models in the performance of detecting csPCa
- timeFrame
- Upon study completion since data from all subjects need to be included (Until 6 months after the last patient got included)
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
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.).
References
Publications (0)
Data not yet available