Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 11:03 PM
Ignite Modification Date:
2025-12-24 @ 11:03 PM
NCT ID:
NCT06281769
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
Healthy Volunteers:
True
Sex:
MALE
Minimum Age:
18 Years
Study:
NCT06281769
Study Brief:
Protocol Section:
NCT06281769