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 @ 3:53 AM
Ignite Modification Date:
2025-12-25 @ 3:53 AM
NCT ID:
NCT03237702
Eligibility Criteria:
Inclusion Criteria:
1. Subjects who have planned to undergo prostate biopsy or have completed biopsy before 6 weeks.
2. Subjects who are aged between 30 and 100 years men.
3. For subjects who are prostate cancer patients for rebiopsy, the testosterone level should be within normal limit (testosterone \>1.5 ng/ml).
4. Subjects who understand the entire study procedures and consent to donate his spot urine (once for 50 ml) and agree with subsequent analyses of his clinical information including biopsy results, treatments and outcomes. (Note: Subjects will be told that the urine metabolomics results will not be revealed to them.)
Exclusion Criteria:
1. Subjects who have other active cancers. However, subjects who have cancers that have been curatively treated and who are disease-free for 3 years or longer are allowed to be enrolled.
2. Subjects who have severe organ function impairment which may significantly alter general cell metabolism determined by the investigators, such as or Cre \> 3.0, HbA1c \> 9.0%, symptomatic heart failure, or other symptomatic metabolic diseases.
3. Subjects who are receiving or have received systemic therapy, such as chemotherapy, androgen deprivation therapy (ADT), immunotherapy, or targeted therapy within 3 months of the screening.
4. Subjects who have been treated with pelvic radiotherapy within 3 months of the screening.
5. Subjects who have significant infection or inflammation within 8 weeks of the biopsy.
6. Subjects who have pyuria (defined as \> 5 WBC/HPF) of urinalysis results within 4 weeks of the biopsy
7. Topical or oral prednisolone equivalent dosage larger 10 mg per day for 14 days or more.
8. The last dose of prednisolone is within 4 weeks of the biopsy.
9. Subjects who have a life expectancy less than 12 months.
10. Subjects who use MCS or found supplementation containing large amount of lycopene in recent 60 days or less. The definition of large amount of lycopene is more than 2 mg per day.
Healthy Volunteers:
False
Sex:
MALE
Minimum Age:
30 Years
Maximum Age:
100 Years
Study:
NCT03237702
Study Brief:
Protocol Section:
NCT03237702