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 @ 12:31 PM
Ignite Modification Date:
2025-12-24 @ 12:31 PM
NCT ID:
NCT05137561
Eligibility Criteria:
Inclusion Criteria:
1. PIRADS 4 and 5 prostate lesions and PIRADS \</= 3 prostate lesions with high clinical suspicion.
2. Patients who are included in the study will be randomly allocated into either PSMA PET/CT guided biopsy or TRUS guided biopsy using simple randomization in RRApp
Exclusion Criteria:
1. Patients with acute prostatitis/ urine culture positive.
2. Patients with pre-existing bleeding diathesis like hemophilia, coagulopathy defined by INR ≥ 1.2, and Platelet counts ≤ 80,000/mm3
3. Patients who refuse to provide the written informed consent
4. Non-cooperative patients
Healthy Volunteers:
True
Sex:
MALE
Minimum Age:
45 Years
Maximum Age:
90 Years
Study:
NCT05137561
Study Brief:
Protocol Section:
NCT05137561