Clinical trial · Observational
MRI Before Biopsy in Diagnosing Patients With Prostate Cancer
Novel Screening MRI for the Detection 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): Principal Investigator Left Institution
Summary
Brief summary (as posted)
This pilot clinical trial studies how well magnetic resonance imaging (MRI) before biopsy works in diagnosing patients with prostate cancer. MRI is a procedure in which radio waves and a powerful magnet linked to a computer are used to create detailed pictures of areas inside the body. This diagnostic procedure may aid in identifying lesions in the prostate which may have cancer. The lesions can then be targeted during the prostate biopsy to improve the accuracy of identifying prostate cancer.
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 |
|---|---|---|---|
| magnetic resonance imaging | Device | — | UNRESOLVED |
| prostate biopsy | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Diagnostic (MRI and biopsy)
- description
- Participants undergo pelvic magnetic resonance imaging (MRI). Within 1-2 weeks, patients undergo scheduled prostate biopsy.
- interventionNames
- Device: magnetic resonance imaging
- Procedure: prostate biopsy
Primary outcomes (1)
- measure
- Increased detection of clinically significant prostate cancer
- timeFrame
- Up to 1 year
- description
- Percent increase of patients with positive prostate cancer biopsies detected with pelvic MRI quick scan from the anticipated detection rate of 40%
Secondary outcomes (2)
- measure
- Detection of clinically significant prostate cancer using 3D T2 SPACE
- timeFrame
- Up to 1 year
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 40 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * Abnormal prostate-specific antigen (PSA) blood test * \> 2.5 ng/mL for men \< 50 years (yrs) of age * \> 3.5 ng/mL for men \< 60 yrs of age * \> 4.5 ng/mL for men \< 70 yrs of age * Abnormal digital rectal exam (i.e. palpable nodule, induration or firm area to the prostate) * Scheduled for a TRUS biopsy based on clinical suspicion for prostate cancer Exclusion Criteria: * Individuals who have previously undergone biopsy of the prostate for diagnosis of prostate cancer * Contraindications to TRUS/prostate biopsy (BX) * Currently on blood thinning agents (Plavix, Coumadin etc.) or bleeding disorder * Active urinary tract infection * Acute painful perianal disorder (i.e. rectal abscess) * Contraindications to MRI * 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 claustrophobia * Individuals with a short life expectancy (\< 10 years)
References
Publications (0)
Data not yet available