Prostate Cancer Detection Rate of Targeted Biopsies With PCaVision

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

The primary objective is to demonstrate 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 clinically significant cancer in targeted biopsies based on MRI (MRI pathway).

All patients will undergo imaging using MRI and PCaVision during which suspicious lesions will be identified based on each imaging technique independently with readers being blinded for the results of the other imaging technique. Thereafter, a MRI targeted 3-core biopsy per lesion (maximum of 2 lesions) and/ or a PCaVision targeted 3-core biopsy (maximum of 2 lesions) will be performed by a one physician if suspicious lesions have been identified based on imaging. If lesions have been identified with both PCaVision and MRI in the same patient, the order of the targeted biopsies will be randomized. If the same lesion has been identified on both MRI and PCaVision, both a MRI-targeted and a PCaVision targeted biopsy will be separately performed. Histological examination of the targeted biopsies will be performed to determine presence of clinically significant prostate cancer.

Inclusion Criteria:

• be male
• have an age of 18 years or older
• be biopsy naïve
• have a clinical suspicion of prostate cancer
• be scheduled for evaluation by prostate MRI based on a suspicious DRE and/or elevated serum PSA
• have signed informed consent

Exclusion Criteria:

• 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.
• medical history of prostate surgery
• treatment of 5 alpha-reductase inhibitors for at least 3 months