Clinical trial · Interventional
PRostate Evaluation for Clinically Important Disease: MRI vs Standard Evaluation Procedures
A Phase III Multi-centre Open-label Randomized Controlled Trial of Multi-parametric Magnetic Resonance Imaging (MRI)-Targeted Biopsy Compared to Systematic Trans-rectal Ultrasound (TRUS) Guided Biopsy
- 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 aim of this study is to assess the efficacy of MRI-targeted biopsy compared to standard of care systematic TRUS guided biopsy in the detection of clinically significant and clinically insignificant prostate cancer in men without prior biopsy. The implication of this trial is that MRI-targeted biopsy could replace systematic TRUS guided biopsy as the standard of care in the diagnosis of 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 (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| MRI | Procedure | — | UNRESOLVED |
| MRI Targeted Biopsy | Procedure | — | UNRESOLVED |
| Standard of Care | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- OTHER
- label
- MRI
- description
- Men in Arm A will undergo a MRI followed by either a targeted biopsy of suspicious areas or will be followed for two years if there is no suspicious areas identified by MRI. The unbiopsied men will have a repeat MRI at 2 years.
- interventionNames
- Procedure: MRI
- Procedure: MRI Targeted Biopsy
- type
- ACTIVE_COMPARATOR
- label
- Standard of Care
- description
- Men in Arm B will undergo a 12-core systematic TRUS guided biopsy. All men in the study will be followed for two years or until they have had radical treatment (whichever comes first).
- interventionNames
- Procedure: Standard of Care
Primary outcomes (1)
- measure
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: In order to be eligible, all inclusion criteria must be met: 1. Men at least 18 years of age referred with clinical suspicion of prostate cancer who have been advised to have a prostate biopsy; 2. ≥5% chance of high-grade prostate cancer as calculated using individualized risk assessment of prostate cancer calculator, PCPTRC 2.0, found at http://deb.uthscsa.edu/URORiskCalc/Pages/calcs.jsp; 3. Serum PSA ≤ 20ng/ml within 3 months of randomization 4. Fit to undergo all procedures listed in protocol; 5. Able to provide written informed consent. Exclusion Criteria: 1. Prior prostate biopsy 2. Prior treatment for prostate cancer 3. Contraindication to MRI (e.g. claustrophobia, pacemaker, estimated GFR ≤ 50mls/min) 4. Contraindication to prostate biopsy 5. Men in whom artifact would reduce the quality of the MRI, i.e. previous hip replacement surgery, metallic hip replacement or extensive pelvic orthopaedic metal work 6. Unfit to undergo any procedures listed in protocol.
References
Publications (2)
- DERIVEDKlotz L, Chin J, Black PC, Finelli A, Anidjar M, Machado A, Levental M, Ghai S, Chang SD, Patel C, Kassam Z, Loblaw A, Kebabdjian M, Pond G, Haider MA. Magnetic Resonance Imaging-Targeted Versus Systematic Prostate Biopsies: 2-year Follow-up of a Prospective Randomized Trial (PRECISE). Eur Urol Oncol. 2024 Jun;7(3):456-461. doi: 10.1016/j.euo.2023.09.013. Epub 2023 Oct 12. PMID 37838556
- DERIVEDKlotz L, Chin J, Black PC, Finelli A, Anidjar M, Bladou F, Mercado A, Levental M, Ghai S, Chang SD, Milot L, Patel C, Kassam Z, Moore C, Kasivisvanathan V, Loblaw A, Kebabdjian M, Earle CC, Pond GR, Haider MA. Comparison of Multiparametric Magnetic Resonance Imaging-Targeted Biopsy With Systematic Transrectal Ultrasonography Biopsy for Biopsy-Naive Men at Risk for Prostate Cancer: A Phase 3 Randomized Clinical Trial. JAMA Oncol. 2021 Apr 1;7(4):534-542. doi: 10.1001/jamaoncol.2020.7589. PMID 33538782