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:
2026-03-26 @ 3:17 PM
Ignite Modification Date:
2026-03-26 @ 3:17 PM
NCT ID:
NCT07332832
Eligibility Criteria:
Inclusion Criteria:
* Aged 18 to 85 years.
* Total PSA (tPSA) level ranging from 3 ng/ml to 20 ng/ml (inclusive).
* Underwent prostate MRI at the study institution with complete imaging sequences.
* Capable of providing written informed consent.
* Patients with PI-RADS 4-5, or PI-RADS 3 combined with PSAD ≥ 0.2 ng/ml², who have undergone prostate biopsy with no diagnosis of clinically significant prostate cancer (csPCa).
* Biopsy-naïve patients with PI-RADS 2, or PI-RADS 3 combined with PSAD \< 0.2 ng/ml².
Exclusion Criteria:
* Pathologically confirmed diagnosis of clinically significant prostate cancer (csPCa).
* Contraindications to prostate biopsy or inability to tolerate the procedure.
* Current use of 5-alpha reductase inhibitors (5-ARIs).
* History of hip replacement, metallic hip arthroplasty, or extensive pelvic orthopedic surgery with metallic hardware, or presence of other implants that would degrade MRI image quality.
* Contraindications to bi-parametric MRI (bpMRI) (e.g., severe claustrophobia, cardiac pacemakers).
Healthy Volunteers:
False
Sex:
MALE
Minimum Age:
18 Years
Maximum Age:
85 Years
Study:
NCT07332832
Study Brief:
Protocol Section:
NCT07332832