Clinical trial · Observational
Prostate Cancer Localization With a Multiparametric Magnetic Resonance (MR) Approach
Prostate Cancer Localization With a Multiparametric MR Approach
NCT01138527CI-TRIAL-00051774PCa-MAPcompletedClinicalTrials.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 objective of this prospective multi-centre study is to prove the diagnostic accuracy of in vivo 3T multi-modality Magnetic Resonance Imaging (high resolution T2-weighted MRI, DCE-MRI, MRSI and DWI techniques) in distinguishing carcinoma from other prostate tissue. The gold standard for distinguishing the tissue types is the analysis of whole-mount sections of the resected prostate by a genitourinary histopathologist.
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 | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Biopsy-proven prostate cancer
- description
- Patients with biopsy-proven prostate cancer, planned for radical prostatectomy
- interventionNames
- Other: MRI examination
Primary outcomes (1)
- measure
- Area under the ROC curve to distinguish between cancer and non-cancer tissue in the prostate
- timeFrame
- December 2015
Secondary outcomes (1)
- measure
- Area under the ROC curve to separate low aggressive from intermediate and high aggressive prostate cancer
- timeFrame
- december 2015
Eligibility
Eligibility (as posted)
- Sex
- Male
Show eligibility criteria text
Inclusion Criteria: * Biopsy-proven diagnosis of adenocarcinoma of the prostate * Subject will sign a consent form prior to study entry * Radical prostatectomy and histopathological exam planned * The time interval between last biopsy and the MR exam must be at least 4 weeks * The time interval between MR exam and radical prostatectomy should not exceed 12 weeks Exclusion Criteria: * Subjects who are unable to give valid informed consent * Subjects who are unwilling or unable to undergo an MR exam, including subjects with contra-indications to MR exams * Therapy or surgical procedure applied to the prostate or to other organs in vicinity to the prostate: among the therapies preventing inclusion are any form of radiation therapy, cryo-therapy, thermal-therapy, therapy based on any other medication (including hormonal therapy). * Patients under hormone deprivation therapy.
References
Publications (0)
Data not yet available
No reference posted for this study.