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:
2025-12-25 @ 3:19 AM
Ignite Modification Date:
2025-12-25 @ 3:19 AM
NCT ID:
NCT05422105
Eligibility Criteria:
Inclusion Criteria
1. The participants are male adults over 20 years old.
2. The participants are suspected prostate cancer patients by a serum PSA value of 4-20 ng/ml or a serum PSA value of \< 4ng/ml but noted abnormal lesion by DRE.
3. The participants agree to receive TRUS Bx or mpMRI fusion Bx examination.
4. The participants are the first time to receive a prostatic biopsy.
Exclusion Criteria
1. The participants are diagnosed with prostate cancer before this study.
2. The participants have received any related treatment for prostate cancer.
3. The participants have chronic prostatitis.
4. The participants' serum hemoglobin lowers than 10 mg/dl within 1 month.
5. The participants' serum platelet lowers than 15 103/uL within 1 month.
6. The participants' serum prothrombin time (PT) is prolonged longer than 1.2-fold within 1 month.
7. The participants' serum active partial prothrombin time (aPPT) is prolonged longer than 45 seconds within 1 month.
8. The participants have hemorrhagic disease such as Hemophilia, Von Willebrand disease, thrombocytopenia, systemic Lupus Erythematosus, etc. within 6 months.
9. The participants have conditions of poor immunity status such as HIV infection, receiving treatment for other cancer, DM poor control, use of immunomodulator (ex.
steroid, etc.) within 6 months.
10. The participants have hypertension poor control that is BP cannot be controlled lower than 140/90mmHg whether or not taking medication within 6 months.
11. The participants have suffered from CVA including infarctions and hemorrhages within 6 months.
12. The participants have suffered from angina including stable and unstable types within 6 months.
13. The participants have suffered from arrythmia poor control within 6 months.
14. The participants have suffered from liver dysfunction such as AST/ALT ratio \>2、total bilirubin \>1.5 mg/dL within 6 months.
15. The participants are allergic to any radiopharmaceutical or imaging agent.
16. The participants suffered stage IV chronic kidney disease (eGFR\<30 mL/min/1.73 m2) within 6 months
17. The participants suffered acute kidney injury within 6 months.
18. The participants are absolute and relative contraindications to MRI examination.
Healthy Volunteers:
False
Sex:
MALE
Minimum Age:
20 Years
Maximum Age:
100 Years
Study:
NCT05422105
Study Brief:
Protocol Section:
NCT05422105