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:
2025-12-26 @ 11:13 PM
Ignite Modification Date:
2025-12-26 @ 11:13 PM
NCT ID:
NCT05761912
Eligibility Criteria:
Inclusion Criteria:
1. Age ≥55 years old.
2. Patients had multiparametric magnetic resonance imaging (mpMRI) data within 3 months before biopsy and tPSA/fPSA within 1 month before biopsy.
3. Patients had any of the following indications for prostate biopsy:
* Suspicious prostate nodules were found by digital rectal examination
* Suspicious lesions were detected by B-ultrasound or MRI
* PSA\>10ng/ml
* PSA 4-10ng/ml, with abnormal f/tPSA and/or PSAD values
Exclusion Criteria:
1. malignant tumors other than prostate adenocarcinoma indicated by pathology.
2. Combined with other malignant tumors (such as rectal cancer, bladder cancer, testicular cancer, etc.) that may affect the imaging findings of transrectal ultrasound or mpMRI.
3. Other conditions that would preclude needle biopsy: cachexia, decompensation of organ function, hemorrhagic diseases, local infection, etc
Healthy Volunteers:
False
Sex:
MALE
Minimum Age:
55 Years
Study:
NCT05761912
Study Brief:
Protocol Section:
NCT05761912