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New treatment option for Significant Prostate Cancer
Official title Decipher Lethal Prostate Cancer Biology - Urine Metabolomics
ClinicalTrials.gov ID: NCT03237702
What this study is testing
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 30 to 100, men only
You may be able to join if
- people who have planned to undergo prostate biopsy or have completed biopsy before 6 weeks.
- people who are aged between 30 and 100 years men.
- For people who are prostate cancer patients for rebiopsy, the testosterone level should be within normal limit (testosterone \>1.5 ng/ml).
- people who understand the entire study procedures and consent to donate his spot urine (once for 50 ml) and agree with subsequent analyses of his...
You likely can't join if
- people who have other active cancers. However, people who have cancers that have been curatively treated and who are disease-free for 3 years or...
- people who have severe organ function impairment which may significantly alter general cell metabolism determined by the investigators, such as or...
- people who are receiving or have received systemic therapy, such as chemotherapy, androgen deprivation therapy (ADT), immunotherapy, or targeted...
- people who have been treated with pelvic radiotherapy within 3 months of the screening.
- people who have significant infection or inflammation within 8 weeks of the biopsy.
- people who have pyuria (defined as \> 5 WBC/HPF) of urinalysis results within 4 weeks of the biopsy
See the full eligibility criteria
- people who have planned to undergo prostate biopsy or have completed biopsy before 6 weeks.
- people who are aged between 30 and 100 years men.
- For people who are prostate cancer patients for rebiopsy, the testosterone level should be within normal limit (testosterone \>1.5 ng/ml).
- people 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...
- people who have other active cancers. However, people who have cancers that have been curatively treated and who are disease-free for 3 years or longer are allowed to be enrolled.
- people 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...
- people 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.
- people who have been treated with pelvic radiotherapy within 3 months of the screening.
- people who have significant infection or inflammation within 8 weeks of the biopsy.
- people who have pyuria (defined as \> 5 WBC/HPF) of urinalysis results within 4 weeks of the biopsy
- 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.
- people who have a life expectancy less than 12 months.
- people 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.
The study team makes the final eligibility decision.
Where it's taking place
- Taipei, Taiwan
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling male, 30 years to 100 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Taipei, Taiwan. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.