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 @ 11:58 AM
Ignite Modification Date:
2025-12-24 @ 11:58 AM
NCT ID:
NCT06575361
Eligibility Criteria:
Inclusion Criteria:
* The age of the patient is between 45 and 85.
* Patients with complete multiparametric magnetic resonance imaging (mpMRI) data, qualified image quality control.
* Patients were in accordance with the indication of prostate biopsy, including patients with suspicious prostate nodes found by digital rectal examination (DRE), the suspicious lesions found by transrectal ultrasound (TRUS) or MRI, total prostate-specific antigen (tPSA) \>10ng/mL, tPSA 4-10ng/mL with free-to-total PSA ratio (f/tPSA) \<0.16 or PSA density (PSAD) \>0.15.
* Patients had no history of prior prostate surgery or biopsy.
* The PSA of patients should be ≤20 ng/mL.
* The prostate biopsy pathological results of above lesions were complete. The time interval between targeted prostate biopsy and prostate mpMRI examination should not exceed one month.
* Patients with complete clinical information.
Exclusion Criteria:
* The clinicopathological information and mpMRI data was unqualified or incomplete.
* Patients had received radiotherapy, chemotherapy, androgen deprivation therapy, or surgery treatment before prostate mpMRI examination or prostate biopsy.
* Patients received prior prostate biopsy.
* Patients had contraindications to MRI or prostate biopsy.
* Patients were not in accordance with the indication of prostate biopsy.
Healthy Volunteers:
False
Sex:
MALE
Minimum Age:
45 Years
Maximum Age:
85 Years
Study:
NCT06575361
Study Brief:
Protocol Section:
NCT06575361