Clinical trial · Observational
Evaluation of Modern MRI in the Diagnosis of Prostate Cancer in a Danish Setup
- 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)
Clinical staging of prostate cancer in Denmark is determined solely by digital rectal examination and sometimes by TRUS, even though the investigators know these examinations are inaccurate and have limitations. Since the majority of men diagnosed with prostate cancer will die with their disease and not of their disease, and the different treatment-options may imply greater side effects, it is important to improve the diagnostic localization and staging of the tumour for optimal clinical management and therapy selection. The development of modern multiparametric-high-field-magnetic-imaging (mMRI) offers new possibilities and approaches in detection, localization and staging of prostate cancer due to its high resolution and soft-tissue contrast. mMRI can provide information about the morphological, metabolic and cellular changes and characterize tissue- and tumour- vascularity and correlate it with tumour aggressiveness. This helps to locate and stage a possible tumour and to guide targeted-biopsies towards disease-suspicious areas. Internationally published data support the rapidly growing use of multiparametric MRI, as being the most sensitive and specific imaging tool for prostate cancer patients. While mMRI internationally is a well recognized and accepted method for detection, localization and staging of prostate cancer, the use of mMRI in the diagnosis of PCa in Denmark has never been applied. Therefore, this project is carried out in order to evaluate the use of modern mMRI in the diagnosis of prostate cancer in a Danish setup.
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 magnetic resonance imaging (mMRI) | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- localized prostate cancer
- description
- Danish men with localized prostate cancer
- interventionNames
- Other: Multiparametric magnetic resonance imaging (mMRI)
Primary outcomes (1)
- measure
- Change in the diagnosis and treatment planning based on MRI examination
- timeFrame
- The participants will be followed for the duration of the hospital diagnostic investagation, an expected average of 4 weeks
- description
- Study 1: Change in clinical T-stage (TNM-classification) at baseline compared to the patological T-stage after curative treatment approx. 4 weeks later. Study 2: Change in prostatic volumen expressed in milliliter(ml) on CT and MRI 4 weeks after brachytherapy-operation compared to the prostatic volumen on TRUS at baseline. Study 3: Change detectionrate of prostatecancer using MRI-targeted biopsies.
Secondary outcomes (1)
- measure
- To gain experience in the use of modern multiparametric MRI in Denmark to evaluate prostatic tumors.
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria Study 1: * Patients with newly diagnosed localized (T1-2) or locally advanced (T3)prostate cancer Exclusion Criteria Study 1: * Metastatic prostate cancer * 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 years Inclusion Criteria Study 2: \- Patients with localized prostate cancer who underwent brachytherapy 4 weeks prior to MRI. Exclusion Criteria Study 2: * Metastatic prostate cancer * Prostate cancer treatment other than Brachytherapy * 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 years Inclusion Criteria Study 3: * Patients scheduled for re-biopsy due to continuing suspicion of prostate cancer after standard TRUS-guided biopsies with negative findings. Exclusion Criteria Study 3: * Histological positive prostate biopsies and known prostate cancer * Metastatic prostate cancer * 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 years
References
Publications (0)
Data not yet available