Understanding prostate cancer through urine analysis

Decipher the Biology of Lethal Prostate Cancer - Urine Metabolomics Profiling in Men Receiving Prostate Biopsy and Men With Diagnosed Prostate Cancer Receiving MCS Supplementation

This study is testing if analyzing urine can help identify important signs of prostate cancer in men and women who are having or just had a prostate biopsy.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 2000 (estimated)
• Ages: 30 Years to 100 Years
• Sex: Male
• Sponsor: National Taiwan University Hospital (other)
• Drugs / interventions: chemotherapy, immunotherapy
• Locations: 1 site (Taipei)
• Trial ID: NCT03237702 on ClinicalTrials.gov

What this trial studies

This study aims to identify new biomarkers for significant prostate cancer by analyzing urine metabolomics. It involves a prospective, observational approach with three cohorts: a training cohort to develop predictive models, a validation cohort to test these models, and a control cohort. The study will enroll 620 men and 20 women, focusing on those undergoing prostate biopsy or who have recently completed one. The goal is to improve screening and reduce overtreatment of insignificant prostate cancer.

Who should consider this trial

Good fit: Ideal candidates are men aged 30 to 100 who are scheduled for a prostate biopsy or have undergone one within the last six weeks.

Not a fit: Patients with other active cancers or severe organ function impairment may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to more accurate screening methods for prostate cancer, potentially reducing unnecessary treatments.

How similar studies have performed: Other studies have shown promise in using metabolomics for cancer detection, but this specific approach is relatively novel.

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.

Where this trial is running

Taipei

• Department of Urology, National Taiwan University Hospital — Taipei, Taiwan (RECRUITING)

Study contacts

• Principal investigator: Yeong-Shiau Pu, MD PhD — Department of Urology, National Taiwan University Hospital
• Study coordinator: Chung-Hsin Chen, MD PhD

Conditions: Significant Prostate Cancer, prostate cancer, prostate biopsy, biomarkers, metabolomics, overtreatment, cancer screening, urine