NCT06935487

Brief Summary

The goal of this clinical trial is to learn if a new ultrasound-based imaging method (PCaVision) can accurately detect clinically significant prostate cancer in adult men (18 years and older) who are either undergoing initial evaluation or are already in active surveillance for prostate cancer. The main questions it aims to answer are:

  • Does PCaVision detect clinically significant prostate cancer as accurately as MRI?
  • Can some men safely avoid prostate biopsies based on PCaVision imaging results? Researchers will compare PCaVision-guided biopsies to MRI-guided biopsies to see if PCaVision performs as well as MRI in identifying aggressive prostate cancers. Participants will:
  • Undergo both an MRI and a PCaVision ultrasound scan
  • Receive targeted prostate biopsies based on any suspicious areas found in either scan
  • Possibly have follow-up visits to monitor for biopsy-related side effects

Trial Health

82
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
806

participants targeted

Target at P75+ for not_applicable prostate-cancer

Timeline
12mo left

Started Apr 2025

Geographic Reach
6 countries

10 active sites

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress53%
Apr 2025May 2027

Study Start

First participant enrolled

April 1, 2025

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

April 4, 2025

Completed
16 days until next milestone

First Posted

Study publicly available on registry

April 20, 2025

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2026

Expected
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2027

Last Updated

April 20, 2025

Status Verified

April 1, 2025

Enrollment Period

1.7 years

First QC Date

April 4, 2025

Last Update Submit

April 11, 2025

Conditions

Prostate Cancer

Keywords

prostate cancerprostate biopsyprostate biopsiesartificial intelligencecomputer-aided diagnosismagnetic resonance imagingtargeted biopsyultrasound

Outcome Measures

Primary Outcomes (1)

  • Number of Participants With Clinically Significant Prostate Cancer (csPCa) Detected by PCaVision-Targeted Biopsies Compared to MRI-Targeted Biopsies

    Clinically significant prostate cancer (csPCa) is defined as ISUP Grade Group (GG) ≥ 2. The number of participants in whom csPCa is detected through PCaVision-targeted biopsies will be compared to the number of participants with csPCa detected through MRI-targeted biopsies. The comparison will be performed separately for two patient cohorts: 1. Biopsy-naïve or prior negative biopsy patients 2. Patients under active surveillance (AS) A non-inferiority margin of 5 percentage points will be used.

    12 months

Secondary Outcomes (4)

  • Number of Participants With No Suspicious Lesions on PCaVision and No Clinically Significant Prostate Cancer (csPCa) Detected by MRI-Targeted or Systematic Biopsies

    12 months

  • Number of Participants With Prostate Cancer Detected by PCaVision or MRI According to Alternative Definitions of Clinically Significant Cancer

    12 months

  • Number of Participants With Insufficient Image Quality for Diagnostic Assessment on PCaVision or MRI

    12 months

  • Number of Participants With Clinically Significant Prostate Cancer (csPCa) Detected in Prespecified Subgroups

    12 months

Study Arms (2)

PCaVision Imaging + PCaVision-Targeted Biopsy

EXPERIMENTAL

Participants undergo 3D multiparametric ultrasound (mpUS) imaging using PCaVision, a software-assisted diagnostic tool that combines B-mode, Shear Wave Elastography, and Contrast-Enhanced Ultrasound (CEUS). Suspicious lesions identified by PCaVision will be targeted for biopsy (up to 2 lesions, 3 cores each). * Transrectal 3D mpUS using PCaVision software (v1.1) * Injection of ultrasound contrast agent (SonoVue) * Targeted biopsy based on PCaVision lesion detection (up to 6 cores total)

Diagnostic Test: transrectal ultrasound of prostate (TRUS) with AI software algorithm

MRI Imaging + MRI-Targeted Biopsy

ACTIVE COMPARATOR

Participants undergo multiparametric MRI (mpMRI) of the prostate using 1.5T or 3T MRI systems. Suspicious lesions identified by MRI will be targeted for biopsy (up to 2 lesions, 3 cores each). * Prostate mpMRI with or without contrast * Image analysis following PI-RADS criteria * Targeted biopsy based on MRI lesion detection (up to 6 cores total)

Diagnostic Test: MRI prostate

Interventions

transrectal ultrasound of prostate (TRUS) with AI software algorithmDIAGNOSTIC_TEST

Transrectal ultrasound of prostate (TRUS) with AI software algorithm for detection of lesions suspected for prostate cancer

PCaVision Imaging + PCaVision-Targeted Biopsy
MRI prostateDIAGNOSTIC_TEST

MRI for detection of lesions suspected for prostate cancer

MRI Imaging + MRI-Targeted Biopsy

Eligibility Criteria

Age18 Years+
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • male
  • years of age or older
  • scheduled for evaluation by prostate MRI due to:
  • suspicious digital rectal examination (DRE) and/or
  • Elevated serum PSA levels, or as part of active surveillance (AS) follow-up
  • Have provided written informed consent

You may not qualify if:

  • Active urinary tract infection or prostatitis
  • A history of cardiac right-to-left shunt
  • Allergy to sulphur hexafluoride or any other ingredient in the ultrasound contrast agent SonoVue
  • Current treatment with dobutamine
  • Severe pulmonary hypertension (pulmonary artery pressure \> 90 mmHg), uncontrolled systemic hypertension, or respiratory distress syndrome
  • Any other contraindication to MRI or 3D mpUS imaging
  • Inability to understand the language of the patient information (i.e., language barrier)
  • Previous treatment with focal therapy for prostate cancer (e.g., HIFU, cryotherapy, laser ablation, etc.)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (10)

Institut Paoli- Calmettes

Marseille, France

Location

L'Institut Mutualiste Montsouris

Paris, France

Location

University Klinikum Bonn

Bonn, Germany

Location

Martini-Klinik am UKE

Hamburg, Germany

Location

Urologische Klinik München- Planegg

Planegg, Germany

Location

Università degli Studi di Foggia

Foggia, Italy

Location

University of Padua

Padua, Italy

Location

Amsterdam UMC

Amsterdam, Netherlands

Location

Oslo University hospital Ullevål

Oslo, Norway

Location

Fundació Puigvert

Barcelona, Spain

Location

Related Publications (4)

  • 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: 34324383BACKGROUND

  • 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: 12431818BACKGROUND

  • 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: 39050912BACKGROUND

  • Jager A, Zwart MJ, Postema AW, van den Kroonenberg DL, Zwart W, Beerlage HP, Oddens JR, Mischi M. Development and validation of a framework for registration of whole-mount radical prostatectomy histopathology with three-dimensional transrectal ultrasound. BMC Urol. 2025 Apr 3;25(1):73. doi: 10.1186/s12894-025-01736-4.

    PMID: 40175990BACKGROUND

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital Diseases

Study Officials

  • dr. Oddens, MD, PhD

    Amsterdam UMC

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Masking of Image Interpreters and Outcome Assessors
Purpose
DIAGNOSTIC
Intervention Model
CROSSOVER
Model Details: This study uses a fully paired design, where each participant undergoes both interventions - PCaVision and MRI imaging - and receives biopsies based on each modality within the same study period.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof. Dr. H.P. Beerlage

Study Record Dates

First Submitted

April 4, 2025

First Posted

April 20, 2025

Study Start

April 1, 2025

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

May 1, 2027

Last Updated

April 20, 2025

Record last verified: 2025-04

Data Sharing

IPD Sharing
Will share

IPD Sharing Statement Section * Plan to Share IPD: Yes * Plan Description: De-identified individual participant data (IPD) will be shared with qualified researchers after the main study results are published. Data sharing will be governed by a data use agreement and ethical approvals. • IPD Description: The following individual-level data will be shared: * Participant demographics (e.g., age, PSA level, clinical cohort) * Imaging results from PCaVision and MRI (e.g., lesion scores, heatmaps, image quality) * Histopathological biopsy outcomes (e.g., ISUP Grade Group, csPCa status) * Subgroup classifications (e.g., use of 5-ARI, prior prostate surgery) * Imaging quality and adverse events (de-identified) • Supporting Documents: * Study Protocol * Statistical Analysis Plan (SAP) * Informed Consent Form (ICF) \[if permitted\] • Time Frame: Data will become available after publication of the primary results and completion of the trial, estimated to be around March 2026. Data will remain avail

Shared Documents
STUDY PROTOCOL, SAP, ICF
Time Frame
Data will become available after publication of the primary results and completion of the trial, estimated to be around March 2026. Data will remain available for at least 5 years thereafter.
Access Criteria
Data will be shared with qualified researchers affiliated with academic institutions or non-profit organizations. Requests must include a methodologically sound proposal and will require a data use agreement.

Locations

FR(2)ES(1)NL(1)IT(2)DE(3)NO(1)