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 @ 3:37 PM
Ignite Modification Date:
2025-12-24 @ 3:37 PM
NCT ID:
NCT01455792
Eligibility Criteria:
Inclusion criteria
* Patients without previous biopsies.
* Men aged \< 75 years, in whom it is clinically relevant to decide whether he has prostate cancer.
* PSA \> 3 - 4 ng/ml and \< 20 ng/ml.
* Suspicious findings on DRE or TRUS.
* Informed consent.
Exclusion criteria
* Patients who refuse to sign the consent form for any reason or do not accept the study premises.
* Patients who want to withdraw for any reason during the study.
* Patients with contraindications to MRI (pacemaker, claustrophobia etc.)
* Patients who have already undergone a high quality MRI examination of the prostate within the last year. In this situation the MRI examination will be evaluated together with the surgeon and radiologist on an individual basis. In case of a low quality examination, we will disregard the findings, and include the patient.
An accurate record will be kept of all the excluded patients.
Healthy Volunteers:
False
Sex:
MALE
Study:
NCT01455792
Study Brief:
Protocol Section:
NCT01455792