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

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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON51424

Enrollment

467

Registered

2023-01-27

Start date

2024-03-12

Completion date

Unknown

Last updated

2025-08-25

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

Conditions

prostate cancer Prostate carcinoma

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: • male • age of 18 years or older • biopsy naïve • clinical suspicion of prostate cancer for which prostate MRI is indicated • signed informed consent

Exclusion criteria

Exclusion criteria: • 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 • PSA level above or equal to 100 ng/ml • Medical history of prostate surgery • current treatment of 5 alpha-reductase inhibitors for at least 3 months • incapable of understanding the language in which the patient information is given.

Design outcomes

Primary

Measure	Time frame
The primary endpoint of this study is clinically significant (GG >=2) PCa. The detection rate of this endpoint in any core for each biopsy strategy will be assessed to demonstrate the non-inferiority of PCaVision targeted biopsy strategy in comparison with MRI targeted biopsy strategy. The detection rate is expressed with patients as the unit of analysis.	—

Secondary

Measure	Time frame
The detection rate of the primary endpoint will compared across different biopsy strategies: in any core for PCaVision versus systematic biopsy, MRI versus systematic biopsy and PCaVision + MRI versus systematic biopsy. In addition, we will compare across biopsy strategies: • the capability to detect GG = 1 PCa, GG >= 2 PCa (with and without cribriform growth pattern and/or intraductal carcinoma (CR/IDC)), and GG >= 3 PCa • the GG distribution • the number of men included in the study but excluded for analysis resulting from poor diagnostic imaging / technical issues	—

Measure

Time frame

The detection rate of the primary endpoint will compared across different biopsy strategies: in any core for PCaVision versus systematic biopsy, MRI versus systematic biopsy and PCaVision + MRI versus systematic biopsy. In addition, we will compare across biopsy strategies: • the capability to detect GG = 1 PCa, GG >= 2 PCa (with and without cribriform growth pattern and/or intraductal carcinoma (CR/IDC)), and GG >= 3 PCa • the GG distribution • the number of men included in the study but excluded for analysis resulting from poor diagnostic imaging / technical issues

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Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)