Clinical trial · Interventional
MRI in Active Surveillance of Prostate Cancer
Multi-parametric Magnetic Resonans Imaging in the Diagnosis and Surveillance of Low-risk Prostate Cancer
NCT02326246CI-TRIAL-00026543completedN/AClinicalTrials.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 purpose of this study is to investigate the hypothesis, that mMRI provides a more accurate and secure interpretation of the aggressiveness of prostate cancer initially/before mMRI defined as low risk. In doing so we will investigate and assess the affect of mMRI on gleason score upgrade, risk classification upgrade and changes in treatment strategy (active surveillance vs. operation).
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 |
|---|---|---|---|
| multi-parametic MRI | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- men with low-risk PC
- description
- men newly diagnosed with low-risk prostate cancer and put in an active surveillance (AS) program. Eight weeks post TRUS-guided biopsies they are scanned with a multi-parametric magnetic resonans imaging (mMRI). If the scans shows a PIRADS 4 or 5 lesion, MRI-guided biopsies are performed. Otherwise the patients will continue in the AS program as usual. The mMRI will in these cases be repeated after 1 year.
- interventionNames
- Other: multi-parametic MRI
Primary outcomes (1)
- measure
- gleason up-grate
- timeFrame
- 1 year
Secondary outcomes (1)
- measure
- changes in the treatment strategy
- timeFrame
- 1 year
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Age over 18 years * PC and put in AC, * No contraindications to MRI, * Written informed consent Exclusion Criteria: * Lack of ability to consent, * Non-MRI compatible metal in the body, * Claustrophobia, * Heavy obesity (largest circumference more than 180 cm), * Moderate/severe kidney malfunction * Known allergy to MRI contrast
References
Publications (0)
Data not yet available
No reference posted for this study.