NCT03237702Recruiting
Decipher Lethal Prostate Cancer Biology - Urine Metabolomics
Decipher the Biology of Lethal Prostate Cancer - Urine Metabolomics Profiling in Men Receiving Prostate Biopsy and Men With Diagnosed Prostate Cancer Receiving MCS Supplementation
Source: ClinicalTrials.gov · Last updated 20 Jan 2026
Brief summary (registry, in English)
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 (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 2000 (estimated)
- First submitted
- 31 Jul 2017
- Start date
- 1 Aug 2017
- Primary completion date
- 1 Aug 2027
- Lead sponsor
- National Taiwan University Hospital
- Diseases
- Prostate cancer
- NCT number
- NCT03237702
What you commit to
- Study type: Interventional
- Planned participants: 2000
- From 1 Aug 2017 to the primary completion date, 1 Aug 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
- Subjects who have been treated with pelvic radiotherapy within 3 months of the screening.
Other illness
- 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.
- Subjects who have significant infection or inflammation within 8 weeks of the biopsy.
Lab values
- 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.
- Subjects who have pyuria (defined as \> 5 WBC/HPF) of urinalysis results within 4 weeks of the biopsy
Other
- Topical or oral prednisolone equivalent dosage larger 10 mg per day for 14 days or more.
- The last dose of prednisolone is within 4 weeks of the biopsy.
- Subjects who have a life expectancy less than 12 months.
- 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.
Who the study is looking for
- Subjects who have planned to undergo prostate biopsy or have completed biopsy before 6 weeks.
- Subjects who are aged between 30 and 100 years men.
- For subjects who are prostate cancer patients for rebiopsy, the testosterone level should be within normal limit (testosterone \>1.5 ng/ml).
- 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.)
Age in the registry: 30 years to 100 years · Sex: Male · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Department of Urology, National Taiwan University Hospital Coordinator of this site? Confirm its status | Taipei | Taiwan | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.