Clinical trial · Observational
Quantitative mpMRI to Predict Metastatic Potential of Prostate Cancer
NCT05252806CI-TRIAL-00059221QmpMRIunknownClinicalTrials.gov clinicaltrialsProvenance
- 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)
The primary aim of this study is to assess the potential of quantitative MRI measurements to predict localized prostate cancer T-stage and disease spread to nodes (N-stage) by correlating quantitative MRI measurements of the local prostate to the presence of metastases as seen on PSMA-PET/CT.
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 (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| MRI examination of the prostate | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- optimal combination of quantitative MRI parameters that best correlates to the presence of (lymph node) metastases in prostate cancer as seen on PSMA-PET/CT.
- timeFrame
- within 14 days of PSMA-PET/CT scan, before any therapy
- description
- To find the optimal combination of quantitative parameters for discriminating between positive and negative PSMA-PET/CT, logistic regression modelling will be used. The performance of the model will be evaluated using receiver operating characteristic curve analysis.
Secondary outcomes (3)
- measure
- the performance of individual quantitative MRI parameters discriminating localized from (oligo-)metastatic disease
- timeFrame
- within 14 days of PSMA-PET/CT scan, before any therapy
- description
- To test the individual quantitative MRI parameters for a significant difference between localized and (oligo-)metastatic disease, non-parametric tests for independent groups (Mann-Whitney U test) will be used. The ability of each parameter to discriminate between positive and negative PSMA-PET/CT is assessed using receiver operating characteristic curve analysis, which allows comparison to the logistic regression model performance.
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 50 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically proven primary cancer of the prostate, based on prostate biopsy-core analysis. * Patient is scheduled and fit for PSMA-PET/CT * Age≥50 years. Ability to give voluntary written informed consent to participate in this study. Exclusion Criteria: * Contraindication for MRI-scanning, i.e. claustrophobia, intracranial metal clips, metallic bodies in the eye, implanted electric and electronic devices not eligible for MRI (pacemakers, insulin pumps, cochlear implants, neurostimulators). * Prior prostate cancer treatment. * Prior pelvic surgery, associated with pelvic lymphadenopathy * Presence of any medical condition that in the opinion of the investigator/treating physician will affect patients' clinical status by participating in this trial. * Inability to lie still for 45 minutes or comply with imaging. * The patient is already enrolled in one or more concurrent studies, which could confound the results of this study, according to the investigators.
References
Publications (0)
Data not yet available
No reference posted for this study.