Clinical trial · Interventional
Predicting Prostate Biopsy Results With Biomarkers and mpMRI.
Developing a Multivariable Diagnostic Prediction Model for Prostate Biopsy Outcome Using Biomarkers and mpMRI as Prediction Variables in Biopsy naïve Men.
- 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)
Current standard prostate biopsy techniques, used to definitively diagnose prostate cancer (PC), utilises an ultrasound guided biopsy approach, that offers unsatisfactory specificity and sensitivity for clinical significant PC. This often leads to harmful unnecessary biopsies. To improve the overall detection of clinical significant PC, multiparametric magnetic resonance imaging (mpMRI) has emerged as a new technique that might be useful in selecting the appropriate patient for biopsy. Nevertheless, mpMRI fail to detect cancer in some circumstances and the exact role of mpMRI is undetermined. Currently, the majority of PC is diagnosed either incidentally or by unsystematic screening with prostate specific antigen (PSA). PSA suffers from being an organ specific, but cancer unspecific serum biomarker. PSA testing may neither rule out or confirm the presence of prostate cancer. Newer biomarkers have shown promise in curbing some of this sensitivity and specificity gap, but still needs refinement. In the present study, the investigators will use mpMRI and a new set of urine and plasma biomarkers in combination, prior to performing standard biopsies in order to develop a prediction model for the biopsy outcome. If proven successful the model would offer excellent risk stratification and possibly mitigating the need for 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 |
|---|---|---|---|
| mpMRI | Diagnostic Test | — | UNRESOLVED |
| Urine and plasma biomarkes. | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Standard care
- description
- Study subject will undergo sampling of plasma and urine biomarkers.
- interventionNames
- Diagnostic Test: Urine and plasma biomarkes.
- type
- EXPERIMENTAL
- label
- Magnetic Resonance Imaging.
- description
- Prior to biopsies a magnetic resonance imaging scan will be performed.
- interventionNames
- Diagnostic Test: mpMRI
- Diagnostic Test: Urine and plasma biomarkes.
Primary outcomes (1)
- measure
- Detection of clinical significant cancer.
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: 1. Able to provide informed written consent. 2. PSA \< 20. 3. Referred for prostate biopsy. Exclusion Criteria:: 1. Previously diagnosed with prostate cancer. 2. Active use of anticoagulant (excluding platelet inhibitors) or other contraindication for prostate biopsies. 3. Previously undergone prostate biopsies. 4. Inability to undergo mpMRI scan (pacemaker , claustrophobia, impaired renal function, allergy towards contrast agent etc) 5. Any, previous or current, therapy for benign prostate hyperplasia including surgery or medical therapy (except alpha adrenal blockers). 6. They withdraw their consent.
References
Publications (11)
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- BACKGROUNDStamey TA, Yang N, Hay AR, McNeal JE, Freiha FS, Redwine E. Prostate-specific antigen as a serum marker for adenocarcinoma of the prostate. N Engl J Med. 1987 Oct 8;317(15):909-16. doi: 10.1056/NEJM198710083171501. PMID 2442609
- BACKGROUNDAlbitar M, Ma W, Lund L, Albitar F, Diep K, Fritsche HA, Shore N. Predicting Prostate Biopsy Results Using a Panel of Plasma and Urine Biomarkers Combined in a Scoring System. J Cancer. 2016 Feb 2;7(3):297-303. doi: 10.7150/jca.12771. eCollection 2016. PMID 26918043
- BACKGROUNDPanebianco V, Barchetti F, Sciarra A, Ciardi A, Indino EL, Papalia R, Gallucci M, Tombolini V, Gentile V, Catalano C. Multiparametric magnetic resonance imaging vs. standard care in men being evaluated for prostate cancer: a randomized study. Urol Oncol. 2015 Jan;33(1):17.e1-17.e7. doi: 10.1016/j.urolonc.2014.09.013. Epub 2014 Nov 11.