Significant Prostate Cancer Clinical Trial
Official title:
Decipher the Biology of Lethal Prostate Cancer - Urine Metabolomics Profiling in Men Receiving Prostate Biopsy and Men With Diagnosed Prostate Cancer Receiving MCS Supplementation
Through a better understanding of the biology of significant (lethal) prostate cancer, we hope to develop new markers/targets from urine metabolomics for more effective screening and prevention of significant prostate cancer. In the meantime, with these new markers we may substantially reduce overtreatment of insignificant PC.
| Status | Recruiting |
| Enrollment | 2000 |
| Est. completion date | August 1, 2025 |
| Est. primary completion date | August 1, 2025 |
| Accepts healthy volunteers | No |
| Gender | Male |
| Age group | 30 Years to 100 Years |
| Eligibility | 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. |
| Country | Name | City | State |
|---|---|---|---|
| Taiwan | Department of Urology, National Taiwan University Hospital | Taipei |
| Lead Sponsor | Collaborator |
|---|---|
| National Taiwan University Hospital | Cardinal Tien Hospital, Chang Gung Memorial Hospital, Far Eastern Memorial Hospital, Shin Kong Wu Ho-Su Memorial Hospital, Taichung Tzu Chi Hospital, Taipei Medical University Hospital, Taipei Medical University Shuang Ho Hospital, Taipei Veterans General Hospital, Taiwan |
Taiwan,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Change of urine metabolomics | Observe the change of metabolomics in urine samples collected before and upon the completeness of MCS supplementation | 8 weeks |