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NCT Number: NCT06974539

TULIP ReTrain Study

This prospective clinical study aims to retrain and validate the PCaVision AI algorithm for the detection and localization of clinically significant prostate cancer (csPCa) using multiparametric ultrasound (mpUS) with two different ultrasound contrast agents: Sonovue and Optison. Data will be collected using a commercial version of the LOGIQ E10 ultrasound machine, with full histopathological correlation in patients undergoing radical prostatectomy.

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Key information

Conditions

Prostate Cancer Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasms Neoplasms by Site Prostatic Diseases Prostatic Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

About this study

The PCaVision CAD system was initially developed using Sonovue contrast and a research-only ultrasound machine (LOGIQ E10 R3). In this study, the algorithm will be retrained using data acquired from the LOGIQ E10 R4, a commercially available system, and using both Sonovue and Optison as contrast agents. The goal is to enhance generalizability and enable broader clinical adoption. The study includes two cohorts: patients scheduled for radical prostatectomy (for training and voxel-level validation) and patients with a negative prostate MRI (for patient-level specificity evaluation). All participants will undergo 3D transrectal mpUS with both contrast agents in a single session. Full prostate histology from RP specimens will serve as the reference standard.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Male ≥18 years
  • Cohort 1: Histologically confirmed prostate cancer scheduled for radical prostatectomy
  • Cohort 2: Negative multiparametric prostate MRI (PI-RADS ≤ 2)

Exclusion criteria

  • Severe pulmonary hypertension
  • Cardiac right-to-left shunt
  • Known allergy to Sonovue or Optison
  • Contraindication for ultrasound contrast agents

Treatment and study plan

Multiparametric ultrasound with contrast (Sonovue and Optison)

Diagnostic Test

Participants will receive 3D mpUS using both Sonovue and Optison contrast agents during a single transrectal imaging session.

Primary outcomes

  1. Sensitivity and Specificity of PCaVision Algorithm (Sonovue and Optison) Compared to Histopathology

    Time frame: From baseline imaging to histopathology report (typically within 2-4 weeks post-surgery)

    Sensitivity and specificity of the PCaVision algorithm in detecting and localizing clinically significant prostate cancer (csPCa, Gleason Grade Group ≥2) at the voxel level, based on 3D multiparametric ultrasound (mpUS) images using Sonovue and Optison, validated against full prostate histology after radical prostatectomy.

Secondary outcomes

  1. Specificity of PCaVision in MRI-Negative Cohort

    Time frame: From baseline imaging to completion of image processing and analysis (within 2 weeks of scan)

    Evaluation of the specificity of the PCaVision algorithm for csPCa detection at the patient level in men with a negative prostate MRI (PI-RADS ≤2), using mpUS imaging with Sonovue and Optison.

  2. Diagnostic Performance Comparison Between Sonovue and Optison

    Time frame: Imaging and analysis completed within 4 weeks post-surgery

    Head-to-head comparison of diagnostic performance (sensitivity, specificity, AUC) of PCaVision on mpUS scans obtained with Sonovue versus Optison, using RP histopathology as reference. Evaluated at voxel level and using simulated biopsy protocols.

Study contacts

Contact information is provided by the study sponsor or research team.

Daniel van den Kroonenberg, MD

CONTACT

[email protected]

+31639345375

Stijn van den Bosch, MD

CONTACT

[email protected]

+31646310728

Sponsors and collaborators

Lead sponsor

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

Other

Collaborators

  • Angiogenesis Analytics

Registry information

Official study title

Optimization of PCaVision: A Prospective Study for CAD-based Detection of Clinically Significant Prostate Cancer Using mpUS and Contrast Agents

Acronym: TULIP ReTrain

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
May 16, 2025
Registry last updated
May 16, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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