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 @ 7:06 PM
Ignite Modification Date:
2025-12-24 @ 7:06 PM
NCT ID:
NCT06923657
Eligibility Criteria:
Inclusion Criteria:
* Serum PSA \> 4 ng/mL
* At least one prior negative prostate biopsy
* At least two consecutive increases in PSA and/or PHI
* Negative digital rectal examination
* Multiparametric MRI (mpMRI) indicating a PI-RADS score ≤ 3
Exclusion Criteria
* Age ≤ 30 years or \> 85 years
* Concurrent presence of other malignant tumors
* Previous treatment with any form of anti-tumor therapy or prostate surgery (excluding prostate biopsy)
* Inability to comply with PSMA PET/MRI examination (e.g., contrast allergy, claustrophobia, etc.)
* Contraindications for prostate biopsy (e.g., coagulation disorders, acute prostatitis, acute urinary tract infection, etc.)
* Severe organ dysfunction (e.g., significant cardiac, pulmonary, hepatic, or renal impairment)
* Incomplete clinical or pathological data
Healthy Volunteers:
False
Sex:
MALE
Minimum Age:
30 Years
Maximum Age:
85 Years
Study:
NCT06923657
Study Brief:
Protocol Section:
NCT06923657