Clinical trial · Interventional
Prostate Cancer Detection Rate of Targeted Biopsies With PCaVision
Clinical Validation of Transrectal Multiparametric Ultrasound Imaging Strategy (PCaVision) for the Detection of Clinically Significant Prostate Cancer: a Head-to-head Comparison With the MRI-based Strategy
NCT06281769CI-TRIAL-00093804completedN/AClinicalTrials.gov clinicaltrialsProvenance
- 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 primary objective is to demonstrate non-inferiority of the detection rate of clinically significant prostate cancer (csPCa) in targeted biopsies based on PCaVision imaging (PCaVision pathway) in comparison with the detection rate of clinically significant cancer in targeted biopsies based on MRI (MRI pathway).
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 |
|---|---|---|---|
| 3D multi-parametric ultrasound targeted biopsy pathway using PcaVision | Diagnostic Test | — | UNRESOLVED |
| MRI targeted biopsy pathway | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- OTHER
- label
- Diagnostic evaluation of prostate cancer
- interventionNames
- Diagnostic Test: 3D multi-parametric ultrasound targeted biopsy pathway using PcaVision
- Diagnostic Test: MRI targeted biopsy pathway
Primary outcomes (1)
- measure
- Detection rate of clinically significant prostate cancer (csPCa) in targeted biopsies based on PCaVision imaging in comparison with the detection rate of clinically significant cancer in targeted biopsies based on MRI.
- timeFrame
- Two weeks
- description
- csPCa defined as GG ≥ 2 in any of the biopsy cores taken from a lesion
Secondary outcomes (4)
- measure
- Proportion of men in whom targeted biopsies could be safely omitted in the PCaVision pathway versus the MRI pathway.
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * be male * have an age of 18 years or older * be biopsy naïve * have a clinical suspicion of prostate cancer * be scheduled for evaluation by prostate MRI based on a suspicious DRE and/or elevated serum PSA * have signed informed consent Exclusion Criteria: * active (urinary tract) infection or prostatitis * a patient history with a cardiac right-to-left shunt. * allergic to sulphur hexafluoride or any of the other ingredients of the ultrasound contrast agent SonoVue * current treatment with dobutamine * known severe pulmonary hypertension (pulmonary artery pressure \>90 mmHg), uncontrolled systemic hypertension or respiratory distress syndrome * any (further) contraindication to undergo MRI or 3D mpUS imaging * incapable of understanding the language in which the patient information is given. * medical history of prostate surgery * treatment of 5 alpha-reductase inhibitors for at least 3 months
References
Publications (10)
- BACKGROUNDvan Moorselaar RJ, Voest EE. Angiogenesis in prostate cancer: its role in disease progression and possible therapeutic approaches. Mol Cell Endocrinol. 2002 Nov 29;197(1-2):239-50. doi: 10.1016/s0303-7207(02)00262-9. PMID 12431818
- BACKGROUNDvan den Kroonenberg DL, Jager A, Garrido-Utrilla A, Reitsma JB, Postema AW, Beerlage HP, Oddens JR. Clinical Validation of Multiparametric Ultrasound for Detecting Clinically Significant Prostate Cancer Using Computer-Aided Diagnosis: A Direct Comparison with the Magnetic Resonance Imaging Pathway. Eur Urol Open Sci. 2024 Jul 1;66:60-66. doi: 10.1016/j.euros.2024.06.012. eCollection 2024 Aug. PMID 39050912
- RESULTRusso G, Mischi M, Scheepens W, De la Rosette JJ, Wijkstra H. Angiogenesis in prostate cancer: onset, progression and imaging. BJU Int. 2012 Dec;110(11 Pt C):E794-808. doi: 10.1111/j.1464-410X.2012.11444.x. Epub 2012 Sep 7. PMID 22958524
- RESULTMischi M, Kuenen MP, Wijkstra H. Angiogenesis imaging by spatiotemporal analysis of ultrasound contrast agent dispersion kinetics. IEEE Trans Ultrason Ferroelectr Freq Control. 2012 Apr;59(4):621-9. doi: 10.1109/TUFFC.2012.2241. PMID 22547274
- RESULTKuenen MP, Saidov TA, Wijkstra H, de la Rosette JJ, Mischi M. Spatiotemporal correlation of ultrasound contrast agent dilution curves for angiogenesis localization by dispersion imaging. IEEE Trans Ultrason Ferroelectr Freq Control. 2013 Dec;60(12):2665-9. doi: 10.1109/TUFFC.2013.2865. PMID 24297031
- RESULTPostema AW, Frinking PJ, Smeenge M, De Reijke TM, De la Rosette JJ, Tranquart F, Wijkstra H. Dynamic contrast-enhanced ultrasound parametric imaging for the detection of prostate cancer. BJU Int. 2016 Apr;117(4):598-603. doi: 10.1111/bju.13116. Epub 2015 Jun 29. PMID 25754526
- RESULTPostema AW, Gayet MCW, van Sloun RJG, Wildeboer RR, Mannaerts CK, Savci-Heijink CD, Schalk SG, Kajtazovic A, van der Poel H, Mulders PFA, Beerlage HP, Mischi M, Wijkstra H. Contrast-enhanced ultrasound with dispersion analysis for the localization of prostate cancer: correlation with radical prostatectomy specimens. World J Urol. 2020 Nov;38(11):2811-2818. doi: 10.1007/s00345-020-03103-4. Epub 2020 Feb 20.