Urine test may reveal which prostate cancers are truly dangerous
NCT ID NCT03237702
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study aims to find new markers in urine that can tell the difference between aggressive prostate cancer and slow-growing types that don't need treatment. Researchers will analyze urine samples from 2000 men before and after they take a multi-carotenoid supplement for 8 weeks. The goal is to improve screening and reduce overtreatment of harmless prostate cancers.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Multi-carotenoids (dietary supplement)
- What this could lead to
- If successful, this could lead to a simple urine test to better identify aggressive prostate cancers and avoid unnecessary treatment for harmless ones.
- What could go wrong
- This is an early-stage observational study, not a treatment trial. The urine markers may not prove accurate enough for clinical use, and the supplement part is small and short-term.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 2,000 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Aug 2017
- Expected to finish
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Aug 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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30 to 100 years
- Sex
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Male participants only
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Department of Urology, National Taiwan University Hospital
RECRUITINGTaipei, 100, Taiwan
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Other studies related to the condition(s) this trial covers.
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- Can a blood filtering technique reveal more about prostate cancer spread?