Prostate Cancer Detection Rate of Targeted Biopsies With PCaVision

NCT06281769 | Completed DMC

• 1 other identifier: NL82101.000.22
• Study Type: interventional
• Target: 467
• Locations: 1 country
• Sites: 5

Brief 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).

Conditions

Prostate Cancer

Keywords

contrast enhanced ultrasound; CEUS; Multiparametric Ultrasound; Artificial intelligence; MRI

Outcome Measures

Primary Outcomes (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

  Two weeks

Secondary Outcomes (4)

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

  Two weeks

• 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).

  Two weeks

• 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.

  Two weeks

• 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.

  Two weeks

Study Arms (1)

Diagnostic evaluation of prostate cancer

OTHER

Diagnostic Test: 3D multi-parametric ultrasound targeted biopsy pathway using PcaVision; Diagnostic Test: MRI targeted biopsy pathway

Interventions

3D multi-parametric ultrasound targeted biopsy pathway using PcaVision DIAGNOSTIC_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.

Diagnostic evaluation of prostate cancer

MRI targeted biopsy pathway DIAGNOSTIC_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).

Diagnostic evaluation of prostate cancer

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA): lead
• Angiogenesis Analytics: collaborator

Study Sites (5)

Amsterdam UMC - location VUmc

Amsterdam, Netherlands

Location

Andros Clinics

Baarn, Netherlands

Location

Spaarne Gasthuis

Hoofddorp, Netherlands

Location

St. Antonius

Nieuwegein, Netherlands

Location

Fransiscus Gasthuis

Rotterdam, Netherlands

Location

Related Publications (10)

• 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.

  PMID: 12431818 BACKGROUND

• 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.

  PMID: 39050912 BACKGROUND

• 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.

  PMID: 22958524 RESULT

• 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.

  PMID: 22547274 RESULT

• 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.

  PMID: 24297031 RESULT

• 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.

  PMID: 25754526 RESULT

• 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.

  PMID: 32078707 RESULT

• 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.

  PMID: 32315112 RESULT

• 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.

  PMID: 31246546 RESULT

• 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.

  PMID: 34324383 RESULT

Related Links

• Clinical Trial Protocol: Developing an Image Classification Algorithm for Prostate Cancer Diagnosis on Three-dimensional Multiparametric Transrectal Ultrasound

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof.dr. H.P. Beerlage

Study Record Dates

• First Submitted: February 12, 2024
• First Posted: February 28, 2024
• Study Start: February 26, 2024
• Primary Completion: August 15, 2025
• Study Completion: August 15, 2025
• Last Updated: August 19, 2025

Record last verified: 2025-08

Locations

NL (5)