Clinical trial · Interventional
High Resolution MRI Study for Prostate Cancer
Evaluation of a Novel High-Resolution Diffusion-Weighted MRI Sequence
- 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)
This high resolution MRI (hrMRI), along with stand MRI (sMRI) will be obtained at baseline and again in approximately 1 year in patients on prostate cancer active surveillance. Changes in lesion size and ADC values will be assessed on the serial studies. This study evaluates the hypothesis that hrMRI will detect changes that sMRI cannot detect and that these changes will correlate with prostate cancer progression as determined on prostate biopsy.
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 |
|---|---|---|---|
| high resolution MRI (hrMRI) | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- OTHER
- label
- Paired imaging
- description
- Single arm, paired imaging of high resolution MRI (hrMRI) and stand MRI (sMRI)
- interventionNames
- Diagnostic Test: high resolution MRI (hrMRI)
Primary outcomes (2)
- measure
- Sensitivity and Specificity of High Resolution Versus Standard MRI in Identifying Adverse Histology
- timeFrame
- 6-12 months after enrollment
- description
- The primary endpoint of the clinical trial was the presence of adverse histology (AH) on prostate biopsy. We defined adverse histology (AH) as either overall Gleason score of 7 or more on any biopsy, or an increase of 3 or more positive cores on serial systematic biopsies. The primary hypothesis was that change in tumor size or apparent diffusion coefficient (ADC) as detected by high resolution MRI (hrMRI) would better predict AH than standard MRI (sMRI). AH histology was a measure intended to capture patients with high Gleason grade component (i.e. Gleason Grade 4 or 5) and patients progressing (e.g. from Gleason Group 1 to Gleason Group 2 or from Gleason Group 2 to Gleason Group 3). The sample size was too small and the followup duration of approximately 12 months was too short to assess only true cancer progression as the endpoint. The presence of AH alone is clinically important since these patients may need close followup and may consider definitive local therapy.
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 19 Years
Show eligibility criteria text
Inclusion Criteria: * Age over 18 years * Patients diagnosed with clinically localized prostate cancer * Low or Low-intermediate Risk Prostate cancer1 defined as: * Pre-operative prostate specific antigen (PSA) ≤ 20.0 ng/ml * Clinical stage cT1 or cT2 * Gleason score 3+3 or 3+4 * Patients choosing AS or already on AS as primary management strategy * No previous treatment for prostate cancer with radiotherapy, chemotherapy, or hormonal therapy * No contraindications for gadolinium enhanced MRI Exclusion Criteria: * No exclusion criteria
References
Publications (0)
Data not yet available