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 @ 10:21 PM
Ignite Modification Date:
2025-12-24 @ 10:21 PM
NCT ID:
NCT04607135
Eligibility Criteria:
Inclusion Criteria:
* Men who are scheduled to undergo ultrasound fusion-MR prostate biopsy;
* Men who are willing to participate in the study;
* Subjects must freely sign informed consent to enroll in the study;
* Assessing eligibility: eligibility for the study will be assessed, based upon the above criteria, by the participating urologist at the time of consultation.
* 18 years or older
Exclusion Criteria:
* Men who have had previous treatment for PCa including radiation, cryoablation, chemotherapy, surgery, high intensity focused ultrasound (HIFU), laser therapy or hormone therapy;
* Men who have had previous non-pharmacological invasive or minimally invasive treatment for benign prostatic hypertrophy (BPH) (i.e., TURP, TUMPT, WIT, TUNA, etc);
* standard pharmacological treatment of BPH is allowable
* Men who are mentally impaired and cannot give written consent;
* Men with anomalies of the rectum.
Healthy Volunteers:
False
Sex:
MALE
Minimum Age:
18 Years
Study:
NCT04607135
Study Brief:
Protocol Section:
NCT04607135