Clinical trial · Interventional
Correlation of Imaging Findings With Clinical Findings and Patient Outcomes in Prostate Cancer
Assessment of Advanced Imaging Techniques in the Evaluation and Management of Prostate Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): PI departure - study not conducted.
Summary
Brief summary (as posted)
MRI is being increasingly relied upon for detection, staging and management of prostate cancer. In this study patients with risk of prostate cancer will be recommended to have a pelvic MRI prior to the standard biopsy of the prostate and standard treatment of any detected prostate cancer. The results of the MRI will be compared to standard diagnosis techniques to see if cancer can be more accurately detected.
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 (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| MRI guided biopsy | Device | — | UNRESOLVED |
| TRUS biopsy | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- MRI guided biopsy + TRUS biopsy
- description
- Patients will undergo an MRI guided biopsy and standard trans-rectal ultrasonography-guided (TRUS) biopsy. Results will be compared to see which can more accurately diagnose and manage prostate cancer
- interventionNames
- Device: MRI guided biopsy
- Procedure: TRUS biopsy
Primary outcomes (2)
- measure
- Number of patients with the most likely diagnosis based on the five-point scale - PIRADS
- timeFrame
- Up to two weeks after MRI
- description
- Prostate imaging reporting and data system (PIRADS) scale: 1. Benign; 2. Probably benign; 3. Indeterminate; 4. Probably malignant; 5. Malignant
- measure
- Number of patients with true diagnosis based on biopsy pathology
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 40 Years
- Maximum age
- 90 Years
Show eligibility criteria text
Inclusion Criteria: * Patients with a suspicion (elevated PSA and/or abnormal digital rectal exam)/ diagnosis of prostate cancer Inclusion criteria for sub-group follow-up scans: 1a. Patients who have undergone standard TRUS biopsy or TRUS with targeted biopsy (i.e cognitive TRUS, MR-TRUS fusion or TRUS + in-gantry biopsy) Exclusion Criteria: * Patients with ferromagnetic or otherwise non-MRI compatible aneurysm clips. * The presence of an implanted pacemaker or implanted defibrillator device. * Patients with contraindications for MRI due to embedded foreign metallic objects. Bullets, shrapnel, metalwork fragments, or other metallic material adds unnecessary risk to the patient. * Implanted medical device not described above that is not MRI-compatible; * Known history of severe claustrophobia; * For patients with known history of allergic reaction to magnetic resonance (MR) contrast material or abnormal kidney function (glomerular filtration rate (GFR) \< 30 mL/min), a contrast enhanced exam will not be performed; however, a non-contrast exam may be performed; * Minors will be excluded. * Prisoners and members of other vulnerable populations will be excluded from this study as these populations will not provide any additional unique information to or uniquely benefit from the study.
References
Publications (0)
Data not yet available