Prostate Cancer Detection Rate of Targeted Biopsies With PCaVision
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).
- EligibilityCriteria: 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 - HealthyVolunteers: Accepts Healthy Volunteers - Gender: Male - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult