Prostate Cancer Detection Rate of Targeted Biopsies With PCaVision

March 5, 2024 updated by: Harrie P. Beerlage, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

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).

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

438

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Netherlands
      • Amsterdam, Netherlands
        • Recruiting
        • Amsterdam UMC - location VUmc
      • Baarn, Netherlands
        • Recruiting
        • Andros Clinics
      • Hoofddorp, Netherlands
        • Recruiting
        • Spaarne Gasthuis
      • Nieuwegein, Netherlands
        • Recruiting
        • St. Antonius
      • Rotterdam, Netherlands
        • Recruiting
        • Fransiscus Gasthuis

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Diagnostic evaluation of prostate cancer
Diagnostic test: 3D multi-parametric ultrasound targeted biopsy pathway using PcaVision
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 test: MRI targeted biopsy pathway
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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
csPCa defined as GG ≥ 2 in any of the biopsy cores taken from a lesion
Two weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of men in whom targeted biopsies could be safely omitted in the PCaVision pathway versus the MRI pathway.
Time Frame: Two weeks
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.
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).
Time Frame: Two weeks
(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
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.
Time Frame: Two weeks
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.
Time Frame: Two weeks
Two weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Collaborators

Angiogenesis Analytics

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

February 26, 2024

Primary Completion (Estimated)

January 1, 2025

Study Completion (Estimated)

January 1, 2025

Study Registration Dates

First Submitted

February 12, 2024

First Submitted That Met QC Criteria

February 26, 2024

First Posted (Actual)

February 28, 2024

Study Record Updates

Last Update Posted (Estimated)

March 6, 2024

Last Update Submitted That Met QC Criteria

March 5, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NL82101.000.22

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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