Clinical trial NCT06974539: TULIP ReTrain Study
Official title: Optimization of PCaVision: A Prospective Study for CAD-based Detection of Clinically Significant Prostate Cancer Using mpUS and Contrast Agents
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Prostate Cancer
Keywords: mpUS
CEUS
PCaVision
CAD
Optison
Sonovue
radical prostatectomy
AI diagnosis
Lead sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Sponsor class: OTHER
Collaborators: name: Angiogenesis Analytics
First posted: 2025-05-16
Enrollment: 212
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Sensitivity and Specificity of PCaVision Algorithm (Sonovue and Optison) Compared to Histopathology
timeFrame: From baseline imaging to histopathology report (typically within 2-4 weeks post-surgery)
Secondary outcomes:
measure: Specificity of PCaVision in MRI-Negative Cohort
timeFrame: From baseline imaging to completion of image processing and analysis (within 2 weeks of scan)
measure: Diagnostic Performance Comparison Between Sonovue and Optison
timeFrame: Imaging and analysis completed within 4 weeks post-surgery
Other outcomes:
Locations:
city: Amsterdam
country: Netherlands
facility: Amsterdam UMC
Study officials:
affiliation: Amsterdam UMC
name: Jorg Oddens, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.