Prostate CancerTULIP ReTrainNCT06974539
TULIP ReTrain Study
A study testing Multiparametric ultrasound with contrast (Sonovue and Optison) in people with Prostate Cancer, run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) at 1 site in Netherlands.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- Multiparametric ultrasound with contrast (Sonovue and Optison)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 212 participants
- Where
- 1 siteNetherlands
- Study dates
- Jul 2025to Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male ≥18 years
- Cohort 1: Histologically confirmed prostate cancer scheduled for radical prostatectomy
- Cohort 2: Negative multiparametric prostate MRI (PI-RADS ≤ 2)
Who cannot join
- Severe pulmonary hypertension
- Cardiac right-to-left shunt
- Known allergy to Sonovue or Optison
- Contraindication for ultrasound contrast agents
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Netherlands1 site
Amsterdam UMC
Amsterdam
Stijn van den Bosch, MD, +31646310728, s.m.vandenbosch@amsterdamumc.nl
About this study
Official title: Optimization of PCaVision: A Prospective Study for CAD-based Detection of Clinically Significant Prostate Cancer Using mpUS and Contrast Agents
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.
Read the 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.
- Conditions
- Prostate Cancer
- Being tested
- Multiparametric ultrasound with contrast (Sonovue and Optison)
- Keywords
- mpUS, CEUS, PCaVision, CAD, Optison, Sonovue, radical prostatectomy, AI diagnosis
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| Multiparametric ultrasound with contrast (Sonovue and Optison) | Other | Diagnostic test: Multiparametric ultrasound with contrast (Sonovue and Optison) Receives: Diagnostic Test: Multiparametric ultrasound with contrast (Sonovue and Optison) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitivity and Specificity of PCaVision Algorithm (Sonovue and Optison) Compared to Histopathology
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.
Measured: From baseline imaging to histopathology report (typically within 2-4 weeks post-surgery)
Secondary outcomes (2)
Specificity of PCaVision in MRI-Negative Cohort
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.
Measured: From baseline imaging to completion of image processing and analysis (within 2 weeks of scan)
Diagnostic Performance Comparison Between Sonovue and Optison
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.
Measured: Imaging and analysis completed within 4 weeks post-surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2025
- Study startJul 2025 (estimated)
- Primary completionJul 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 212 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
- Sponsor type
- University, hospital or other
- Collaborators
- Angiogenesis Analytics
- Responsible party
- Principal investigator, Harrie P. Beerlage, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
- Investigators
- Jorg Oddens, MD, PhD, Principal investigator, Amsterdam UMC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06974539
- Sponsor's protocol ID
- NL-009343
- Acronym
- TULIP ReTrain
- Status last verified
- May 2025
- First submitted
- 8 May 2025
- Last updated
- 16 May 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data (IPD) will not be shared for this study because the imaging data and histopathology are linked to highly sensitive clinical records. Due to privacy concerns and the risk of re-identification, even in coded form, sharing of raw participant-level data is not planned. Data will only be used internally for algorithm development and validation under strict confidentiality agreements.
Publications
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.
PubMed 40175990van 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.
PubMed 39050912van 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.
PubMed 12431818Jager 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.
PubMed 34324383
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimization of PCaVision: A Prospective Study for CAD-based Detection of Clinically Significant Prostate Cancer Using mpUS and Contrast Agents
- ClinicalTrials.gov ID
- NCT06974539
- Acronym / sponsor ID
- TULIP ReTrain / NL-009343
- Conditions
- Prostate Cancer
- Keywords
- mpUS, CEUS, PCaVision, CAD, Optison, Sonovue, radical prostatectomy, AI diagnosis
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 212 participants (estimated)
- Lead sponsor
- Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)University, hospital or other
- Collaborators
- Angiogenesis Analytics
- Study start
- Jul 2025 (estimated)
- Primary completion
- Jul 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 16 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Multiparametric ultrasound with contrast (Sonovue and Optison) | Other | Diagnostic Test: Multiparametric ultrasound with contrast (Sonovue and Optison)Diagnostic test: Multiparametric ultrasound with contrast (Sonovue and Optison) |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Male ≥18 years
- Cohort 1: Histologically confirmed prostate cancer scheduled for radical prostatectomy
- Cohort 2: Negative multiparametric prostate MRI (PI-RADS ≤ 2)
Key exclusion criteria (4 listed)
- Severe pulmonary hypertension
- Cardiac right-to-left shunt
- Known allergy to Sonovue or Optison
- Contraindication for ultrasound contrast agents
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Multiparametric ultrasound with contrast (Sonovue and Optison)Participants will receive 3D mpUS using both Sonovue and Optison contrast agents during a single transrectal imaging session. | Diagnostic test | Multiparametric ultrasound with contrast (Sonovue and Optison) |
Primary outcome
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.
2 secondary outcomes
Specificity of PCaVision in MRI-Negative Cohort
Time frame: From baseline imaging to completion of image processing and analysis (within 2 weeks of scan)
Diagnostic Performance Comparison Between Sonovue and Optison
Time frame: Imaging and analysis completed within 4 weeks post-surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2025.
- Background: PubMed 40175990Jager 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.
- Background: PubMed 39050912van 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.
- Background: PubMed 12431818van 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.
- Background: PubMed 34324383Jager 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.
- Angiogenesis Analytics - cooperation partnerLink provided by the sponsor.
- Individual participant dataSharing planned: No. Individual participant data (IPD) will not be shared for this study because the imaging data and histopathology are linked to highly sensitive clinical records. Due to privacy concerns and the risk of re-identification, even in coded form, sharing of raw participant-level data is not planned. Data will only be used internally for algorithm development and validation under strict confidentiality agreements.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jorg Oddens, MD, PhD principal investigator
Amsterdam UMC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Multiparametric ultrasound with contrast (Sonovue and Optison) in people with Prostate Cancer, run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 16 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Stijn van den Bosch, MD (+31646310728, s.m.vandenbosch@amsterdamumc.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06974539, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 May 2025.