Prostate Cancer Detection Rate of Targeted Biopsies With PCaVision

Launched by ACADEMISCH MEDISCH CENTRUM - UNIVERSITEIT VAN AMSTERDAM (AMC-UVA) · Feb 26, 2024

Keywords

ClinConnect Summary

This clinical trial is studying the effectiveness of a new imaging method called PCaVision for detecting significant prostate cancer in men who are suspected of having the disease. The main goal is to see if the detection rates from biopsies guided by PCaVision are as good as those guided by traditional MRI imaging. This is important because finding prostate cancer early can lead to better treatment outcomes.

To participate in this trial, you need to be a male aged 18 or older who has not had a biopsy before and has a suspicion of prostate cancer based on tests like a digital rectal exam or elevated PSA levels. If you choose to join, you’ll undergo imaging tests and biopsies as part of the study. It's important to note that certain health conditions, such as urinary infections or a history of certain heart issues, might prevent you from participating. If you're interested in learning more or considering joining, it’s important to discuss it with your doctor.

Gender

MALE

Eligibility criteria

• 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