Clinical trial · Interventional
Advanced Magnetic Resonance Imaging (MRI) in Men With Suspected Prostate Cancer
Multiparametric Magnetic Resonance Imaging Characterization and Guided Biopsy of the Prostate in Men Suspected of Having Prostate Cancer
- 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)
The clinical trial aims to address the critical challenge of differentiating aggressive from indolent prostate cancers by correlating prospectively collected MultiParametric (MP) Magnetic Resonance Imaging (MRI) data (index test) with the histopathology of radical prostatectomy specimens (reference standard). The study design incorporates pre-biopsy MRI, routine standard of care Transrectal Ultrasound guided (TRUS) biopsies and MRI/Ultrasound (US) image fusion techniques to guide biopsies to the suspicious areas identified by MRI. The hypothesis is that MP-MRI will allow pre-treatment determination of prostate cancer aggressiveness and MRI/US image fusion is expected to accurately co-locate cancer foci within the prostate gland for guiding biopsies. Pre-treatment prediction of Gleason grade as a marker of cancer aggressiveness will better inform clinicians and patients to improve risk stratification and facilitate decision making on subsequent treatment. Image fusion will allow accurate targeting of the most suspicious areas on MP-MRI for biopsy, which could obviate the need for multiple biopsies.
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 |
|---|---|---|---|
| TRUS Biopsy | Procedure | — | UNRESOLVED |
| TRUS/FUSION Biopsy | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- OTHER
- label
- TRUS Biopsy
- description
- Standard of Care Treatment
- interventionNames
- Procedure: TRUS Biopsy
- type
- OTHER
- label
- TRUS/FUSION Biopsy
- description
- Interventional Treatment
- interventionNames
- Procedure: TRUS/FUSION Biopsy
Primary outcomes (2)
- measure
- Number of prostate cancers detected by MP-MRI when compared to gold standard prostatectomy specimen
- timeFrame
- 5 years from first recruitment
- description
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 40 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * Males between the age of 40-75 at referral * With at least 10 years life expectancy * With clinically localised PCa: Prostate Specific Antigen (PSA) ≤20 ng/ml * And/or abnormal Digital Rectal Examination (DRE) but \< T3 disease * Ability to informed consent Exclusion Criteria: * Unable to give informed consent * Prior prostatic biopsy within 12 months * Contraindications to biopsy * Poor general health and life expectancy \< 10 years * Previous diagnosis of acute prostatitis within 12 months * History of prostate cancer * Prior transurethral prostatectomy * Contraindications to MRI (cardiac pacemakers, allergic reaction to gadolinium based contrast, renal function with baseline eGRF 30 ml/min, intracranial clips, claustrophobia) * Previous hip replacement
References
Publications (2)
- DERIVEDWei C, Szewczyk-Bieda M, Bates AS, Donnan PT, Rauchhaus P, Gandy S, Ragupathy SKA, Singh P, Coll K, Serhan J, Wilson J, Nabi G. Multicenter Randomized Trial Assessing MRI and Image-guided Biopsy for Suspected Prostate Cancer: The MULTIPROS Study. Radiology. 2023 Jul;308(1):e221428. doi: 10.1148/radiol.221428. PMID 37489992
- DERIVEDSzewczyk-Bieda M, Wei C, Coll K, Gandy S, Donnan P, Ragupathy SKA, Singh P, Wilson J, Nabi G. A multicentre parallel-group randomised trial assessing multiparametric MRI characterisation and image-guided biopsy of prostate in men suspected of having prostate cancer: MULTIPROS study protocol. Trials. 2019 Nov 21;20(1):638. doi: 10.1186/s13063-019-3746-0. PMID 31752954