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Prostate CancerNCT06281769

Prostate Cancer Detection Rate of Targeted Biopsies With PCaVision

A study testing 3D multi-parametric ultrasound targeted biopsy pathway using PcaVision and MRI targeted biopsy pathway in people with Prostate Cancer, run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) at 5 sites in Netherlands.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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). Read more about this study

Who is it for?
Ages 18 years and older, men onlyHealthy volunteers can take part
Conditions the study is for
Prostate Cancer
What is being tested?
3D multi-parametric ultrasound targeted biopsy pathway using PcaVision and MRI targeted biopsy pathway
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
467 participants
Where
5 sitesNetherlands
Study dates
26 Feb 2024to 15 Aug 2025
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Men only
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 9Show fewer
  • 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

Trial locations and contacts

5 sites in 1 country.

5 sites in 1 country

Netherlands5 sites

  • Amsterdam UMC - location VUmc

    Amsterdam

  • Andros Clinics

    Baarn

  • Spaarne Gasthuis

    Hoofddorp

  • St. Antonius

    Nieuwegein

  • Fransiscus Gasthuis

    Rotterdam

Other trials in Netherlands

About this study

Official title: 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

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).

Read the detailed description

All patients will undergo imaging using MRI and PCaVision during which suspicious lesions will be identified based on each imaging technique independently with readers being blinded for the results of the other imaging technique. Thereafter, a MRI targeted 3-core biopsy per lesion (maximum of 2 lesions) and/ or a PCaVision targeted 3-core biopsy (maximum of 2 lesions) will be performed by a one physician if suspicious lesions have been identified based on imaging. If lesions have been identified with both PCaVision and MRI in the same patient, the order of the targeted biopsies will be randomized. If the same lesion has been identified on both MRI and PCaVision, both a MRI-targeted and a PCaVision targeted biopsy will be separately performed. Histological examination of the targeted biopsies will be performed to determine presence of clinically significant prostate cancer.

Conditions
Prostate Cancer
Being tested
3D multi-parametric ultrasound targeted biopsy pathway using PcaVision, MRI targeted biopsy pathway
Keywords
contrast enhanced ultrasound, CEUS, Multiparametric Ultrasound, Artificial intelligence, MRI
Medical subject headings
Prostatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 3D multi-parametric ultrasound targeted biopsy pathway using PcaVisionDiagnostic test

    The procedure of 3D multiparametric ultrasound consists of 3 components: (1) intravenous administration of ultrasound contrast; (2) rectal multi-parametric ultrasound imaging; (3) PCaVision: artificial intelligence algorithm analyzing the images.

  • MRI targeted biopsy pathwayDiagnostic test

    MRI sequences will include at least T1-weighted, T2-weighted, Diffusion-weighted imaging (DWI) and calculation of apparent diffusion coefficient (ADC) maps. Scoring of suspicion will be performed using the European Society of Urogenital Radiology (ESUR) PI-RADS standardized scoring system. All lesions will be marked and delineated for MRI-TRUS fusion 3D multiparametric ultrasound (mpUS).

Study groups in NCT06281769
Study groupRoleWhat they receive
Diagnostic evaluation of prostate cancerOtherNot described
Receives: Diagnostic Test: 3D multi-parametric ultrasound targeted biopsy pathway using PcaVision; Diagnostic Test: MRI targeted biopsy pathway

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    csPCa defined as GG ≥ 2 in any of the biopsy cores taken from a lesion

    Measured: Two weeks

Secondary outcomes (4)

  1. Proportion of men in whom targeted biopsies could be safely omitted in the PCaVision pathway versus the MRI pathway.

    Defined as the number of men in whom no lesions for target biopsies have been identified by PCaVision while no CsPCa is detected in either MRI targeted biopsies or systematic biopsies.

    Measured: Two weeks

  2. Detection rate of three different definitions of prostate cancer in targeted biopsies based on PCaVision imaging (PCaVision pathway) in comparison with the detection rate of targeted biopsies based on MRI (MRI pathway).

    (i) ISUP ≥ 3 in any of the biopsy cores taken from a lesion; (ii) ISUP ≥ 2 with cribriform growth and/or intraductal carcinoma (CR/IDC) in any of the biopsy cores taken from a lesion; (iii) ISUP = 1

    Measured: Two weeks

  3. Number of men in whom the PCaVision pathway generated insufficient quality images with the number of men with insufficient quality MRI images in the MRI pathway.

    Measured: Two weeks

  4. Detection rate of clinically significant prostate cancer in targeted biopsies based on PCaVision imaging using various incremental levels of PCaVision's image quality requirements in comparison with the detection rate of targeted biopsies based on MRI.

    Measured: Two weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Feb 2024
  2. Study start26 Feb 2024
  3. Primary completion15 Aug 2025
  4. Study completion15 Aug 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Diagnosis
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
467 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06281769
Sponsor's protocol ID
NL82101.000.22
Status last verified
Aug 2025
First submitted
12 Feb 2024
Last updated
19 Aug 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • van 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.

    PubMed 12431818

  • van 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.

    PubMed 39050912

  • Russo 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.

    PubMed 22958524

  • Mischi 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.

    PubMed 22547274

  • Kuenen 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.

    PubMed 24297031

  • Postema 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.

    PubMed 25754526

  • Postema 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.

    PubMed 32078707

  • Mannaerts CK, Engelbrecht MRW, Postema AW, van Kollenburg RAA, Hoeks CMA, Savci-Heijink CD, Van Sloun RJG, Wildeboer RR, De Reijke TM, Mischi M, Wijkstra H. Detection of clinically significant prostate cancer in biopsy-naive men: direct comparison of systematic biopsy, multiparametric MRI- and contrast-ultrasound-dispersion imaging-targeted biopsy. BJU Int. 2020 Oct;126(4):481-493. doi: 10.1111/bju.15093. Epub 2020 May 13.

    PubMed 32315112

  • Mannaerts CK, Wildeboer RR, Remmers S, van Kollenburg RAA, Kajtazovic A, Hagemann J, Postema AW, van Sloun RJG, J Roobol M, Tilki D, Mischi M, Wijkstra H, Salomon G. Multiparametric Ultrasound for Prostate Cancer Detection and Localization: Correlation of B-mode, Shear Wave Elastography and Contrast Enhanced Ultrasound with Radical Prostatectomy Specimens. J Urol. 2019 Dec;202(6):1166-1173. doi: 10.1097/JU.0000000000000415. Epub 2019 Jun 27.

    PubMed 31246546

  • Jager A, Vilanova JC, Michi M, Wijkstra H, Oddens JR. The challenge of prostate biopsy guidance in the era of mpMRI detected lesion: ultrasound-guided versus in-bore biopsy. Br J Radiol. 2022 Mar 1;95(1131):20210363. doi: 10.1259/bjr.20210363. Epub 2021 Jul 29.

    PubMed 34324383

Questions about this trial

What is this clinical trial studying?

A study testing 3D multi-parametric ultrasound targeted biopsy pathway using PcaVision and MRI targeted biopsy pathway in people with Prostate Cancer, run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) at 5 sites in Netherlands.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 19 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome 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. (time frame: Two weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06281769, which also lists 10 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Aug 2025.

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