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European Multicenter Validation of PCaVision: A Head-to-Head Diagnostic Accuracy Study Comparing Multiparametric Transrectal Ultrasound to MRI for Clinically Significant Prostate Cancer Detection

NCT06935487 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 806

Last updated 2025-04-20

No results posted yet for this study

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

Conditions

Interventions

DIAGNOSTIC_TEST

transrectal ultrasound of prostate (TRUS) with AI software algorithm

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

DIAGNOSTIC_TEST

MRI prostate

MRI for detection of lesions suspected for prostate cancer

Sponsors & Collaborators

  • Angiogenesis Analytics

    collaborator INDUSTRY

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

    lead OTHER

Principal Investigators

  • dr. Oddens, MD, PhD · Amsterdam UMC

Study Design

Allocation
NON_RANDOMIZED
Purpose
DIAGNOSTIC
Masking
SINGLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-04-01
Primary Completion
2026-12-31
Completion
2027-05-31

Countries

  • France
  • Germany
  • Italy
  • Netherlands
  • Norway
  • Spain

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06935487 on ClinicalTrials.gov