Clinical trial · Interventional
Multiparametric MRI in Men With Prostate Cancer Enrolled in Active Surveillance
NCT03648359CI-TRIAL-00095035enrolling by invitationN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 17, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260917-000001
Summary
Brief summary (as posted)
To investigate whether multiparametric MRI (mp-MRI) in patients with low-risk prostate cancer can improve the selection of patients suitable for Active Surveillance and have a relevance in the ongoing monitoring
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 |
|---|---|---|---|
| Prostatic Neoplasms | Prostate Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| multiparametric MRI Diagnostics | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- OTHER
- label
- Enrolled AS patients
- description
- Patients with prostate cancer enrolled i active surveillance protocol using PSA, digital rectal examination and conventional TRUS-biopsies
- interventionNames
- Procedure: multiparametric MRI Diagnostics
Primary outcomes (1)
- measure
- Changes in treatment from active surveillance (observation) to active treatment based on mp-MRI results.
- timeFrame
- 12 months
- description
- Patients enrolled in active surveillance will progress to active treatment if mp-MRI show previously undetected suspicious areas of significant disease. Significant cancer (measured by Gleason score and cancer core involvement on biopsies) will be confirmed by repeat biopsies of the suspicious areas. The decision to progress to active treatment is based on decision from the treating urologist.
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * Patients with low risk localized prostate cancer enrolled in active surveillance Exclusion Criteria: * Metastatic prostate cancer * No mp-MRI data present * Prostate cancer treatment * Known allergic reaction to Gadolinium-based MRI contrast agent * Prostate biopsy during the last 21 days * Impaired renal function with GFR \< 30 ml / min * pacemaker * Magnetic metal residues in the body * Claustrophobia * Psychiatric disorders * Age under 18 year
References
Publications (0)
Data not yet available
No reference posted for this study.