Clinical validation of transrectal multiparametric ultrasound imaging strategy (PCaVision) for the detection of clinically significant prostate cancer: a European head-to-head comparison with the MRI-based strategy in primary diagnosis

Clinical validation of transrectal multiparametric ultrasound imaging strategy (PCaVision) for the detection of clinically significant prostate cancer: a European head-to-head comparison with the MRI-based strategy in primary diagnosis - PCaVision II

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON57088

Enrollment

100

Registered

2024-07-03

Start date

2025-11-07

Completion date

Unknown

Last updated

2026-08-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

prostate cancer prostate cancer

Interventions

All patients undergo 3D mpUS using PcaVision and MRI. Suspicious lesions will be identified based on each imaging technique independently. This will be followed by a single biopsy session in which t

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: · be male · have an age of 18 years or older · be scheduled for evaluation by prostate MRI based on a suspicious DRE and/or  elevated serum PSA · have signed informed consent

Exclusion criteria

Exclusion criteria: · under active surveillance for follow up of prostate cancer · active (urinary tract) infection or prostatitis · a patient history with a cardiac right-to-left shunt. · allergic to sulphur hexafluoride or any of the other ingredients of the  ultrasound contrast agent SonoVue · current treatment with dobutamine · known severe pulmonary hypertension (pulmonary artery pressure >90 mmHg),  uncontrolled systemic hypertension or respiratory distress syndrome · any (further) contraindication to undergo MRI or 3D mpUS imaging · incapable of understanding the language in which the patient information is  given. · previous treatment of focal therapy for prostate cancer

Design outcomes

Primary

Measure	Time frame
The primary objectives are to demonstrate the non-inferiority of the detection rate of clinically significant prostate cancer (csPCa) in targeted biopsies based on PCaVision imaging (PCaVision pathway), in comparison with the detection rate of csPCa in targeted biopsies based on MRI (MRI pathway), in a single patient cohort consisting of biopsy-naïve and prior negative patients. In this comparison, csPCa is defined using three complementary definitions, each of which serves as a separate primary endpoint: 1. ISUP =2 in any of the biopsy cores taken from a lesion.  2. ISUP =3 in any of the biopsy cores taken from a lesion.  3. ISUP =2 with the presence of cribriform growth and/or intraductal carcinoma (CR/IDC) in any of the biopsy cores taken from a lesion.	—

Measure

Time frame

The primary objectives are to demonstrate the non-inferiority of the detection rate of clinically significant prostate cancer (csPCa) in targeted biopsies based on PCaVision imaging (PCaVision pathway), in comparison with the detection rate of csPCa in targeted biopsies based on MRI (MRI pathway), in a single patient cohort consisting of biopsy-naïve and prior negative patients. In this comparison, csPCa is defined using three complementary definitions, each of which serves as a separate primary endpoint: 1. ISUP =2 in any of the biopsy cores taken from a lesion.  2. ISUP =3 in any of the biopsy cores taken from a lesion.  3. ISUP =2 with the presence of cribriform growth and/or intraductal carcinoma (CR/IDC) in any of the biopsy cores taken from a lesion.

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Secondary

Measure	Time frame
To compare the proportion of men in whom targeted biopsies could be “safely” omitted in the PCaVision pathway, defined as the number of men in whom no lesions for targeted biopsies were identified by PCaVision while no csPCa is detected in either MRI-targeted or systematic biopsies, compared to the MRI pathway.To perform the same diagnostic assessments described in the primary objectives for additional definitions of the target condition, including:ISUP GG = 1 (i.e., clinically insignificant prostate cancer)To compare the number of men in whom the PCaVision pathway provided insufficient quality imaging with the number of men in whom MRI imaging was of insufficient quality.To calculate the detection rate of csPCa in various subgroups:(i) Men currently receiving 5-alpha reductase inhibitor (5-ARI) treatment for at least 3 months(ii) Men who have undergone prior prostate surgery for lower urinary tract symptoms (LUTS)(iii) Biopsy-naïve and prior negative men excluding those on 5-ARI or with prior prostate surgery	—

Measure

Time frame

To compare the proportion of men in whom targeted biopsies could be “safely” omitted in the PCaVision pathway, defined as the number of men in whom no lesions for targeted biopsies were identified by PCaVision while no csPCa is detected in either MRI-targeted or systematic biopsies, compared to the MRI pathway.To perform the same diagnostic assessments described in the primary objectives for additional definitions of the target condition, including:ISUP GG = 1 (i.e., clinically insignificant prostate cancer)To compare the number of men in whom the PCaVision pathway provided insufficient quality imaging with the number of men in whom MRI imaging was of insufficient quality.To calculate the detection rate of csPCa in various subgroups:(i) Men currently receiving 5-alpha reductase inhibitor (5-ARI) treatment for at least 3 months(ii) Men who have undergone prior prostate surgery for lower urinary tract symptoms (LUTS)(iii) Biopsy-naïve and prior negative men excluding those on 5-ARI or with prior prostate surgery

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Countries

France, Germany, Netherlands

Contacts

Public ContactS.M. van den Bosch

Amsterdam UMC

s.m.vandenbosch@amsterdamumc.nl+31646310728

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP) · Data processed: Aug 25, 2026