Clinical trial · Interventional
PRostate Evaluation for Clinically Important Disease: Sampling Using Image-guidance Or Not?
A Randomized Control Trial of Magnetic Resonance Imaging-targeted Biopsy Compared to Standard Trans-rectal Ultrasound Guided Biopsy for the Diagnosis of Prostate Cancer in Men Without Prior 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)
This evaluates the detection rates of prostate cancer by MRI-targeted prostate biopsy compared to standard 12-core trans-rectal ultrasound guided (TRUS) prostate biopsy. Each participant will be randomly allocated to one of the biopsy tests. We hypothesise that MRI-targeted biopsy will detect no fewer clinically significant cancers than TRUS biopsy but will detect fewer clinically insignificant prostate cancers than TRUS 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 Neoplasm | Prostate Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| MRI | Device | — | UNRESOLVED |
| MRI-targeted biopsy | Procedure | — | UNRESOLVED |
| TRUS-biopsy | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- MRI-arm
- description
- Men in this arm will undergo multi-parametric MRI. In the presence of a suspicious area, a man will undergo MRI-targeted biopsy with cores targeted to the suspicious lesion. In the absence of a suspicious area, no biopsy will be taken.
- interventionNames
- Device: MRI
- Procedure: MRI-targeted biopsy
- type
- ACTIVE_COMPARATOR
- label
- TRUS-biopsy arm
- description
- Men in this arm undergo standard 12-core trans-rectal ultrasound guided prostate biopsy
- interventionNames
- Procedure: TRUS-biopsy
Primary outcomes (1)
- measure
- Proportion of men with clinically significant detected
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 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. Serum PSA ≤ 20ng/ml within the previous 3 months 3. Suspected stage ≤ T2 on rectal examination (organ-confined prostate cancer) within the previous 3 months 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 glomerular filtration rate ≤ 50mls/min) 4. Contraindication to prostate biopsy 5. Men in whom artifact would reduce the quality of the MRI 6. Previous hip replacement surgery, metallic hip replacement or extensive pelvic orthopaedic metal work 7. Unfit to undergo any procedures listed in protocol
References
Publications (2)
- DERIVEDKasivisvanathan V, Rannikko AS, Borghi M, Panebianco V, Mynderse LA, Vaarala MH, Briganti A, Budaus L, Hellawell G, Hindley RG, Roobol MJ, Eggener S, Ghei M, Villers A, Bladou F, Villeirs GM, Virdi J, Boxler S, Robert G, Singh PB, Venderink W, Hadaschik BA, Ruffion A, Hu JC, Margolis D, Crouzet S, Klotz L, Taneja SS, Pinto P, Gill I, Allen C, Giganti F, Freeman A, Morris S, Punwani S, Williams NR, Brew-Graves C, Deeks J, Takwoingi Y, Emberton M, Moore CM; PRECISION Study Group Collaborators. MRI-Targeted or Standard Biopsy for Prostate-Cancer Diagnosis. N Engl J Med. 2018 May 10;378(19):1767-1777. doi: 10.1056/NEJMoa1801993. Epub 2018 Mar 18. PMID 29552975
- DERIVEDKasivisvanathan V, Jichi F, Klotz L, Villers A, Taneja SS, Punwani S, Freeman A, Emberton M, Moore CM. A multicentre randomised controlled trial assessing whether MRI-targeted biopsy is non-inferior to standard transrectal ultrasound guided biopsy for the diagnosis of clinically significant prostate cancer in men without prior biopsy: a study protocol. BMJ Open. 2017 Oct 12;7(10):e017863. doi: 10.1136/bmjopen-2017-017863. PMID 29025845