Urine markers to predict treatment outcomes in prostate cancer
Decipher the Biology of Lethal Prostate Cancer-Using Urine Metabolomics and Proteomics Profiling to Search for Predictive and Prognostic Markers for Treatment Outcomes in Prostate Cancer Patients
This project will test whether molecules in urine can help predict how men with prostate cancer will respond to treatments like surgery, radiation, chemotherapy, or hormone therapy.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 360 (estimated) |
| Ages | 30 Years to 100 Years |
| Sex | Male |
| Sponsor | National Taiwan University Hospital Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Taipei) |
| Trial ID | NCT03237026 on ClinicalTrials.gov |
What this trial studies
This single-center, single-arm translational study will enroll men with newly diagnosed prostate adenocarcinoma who are about to start definitive treatment and have not had prior cancer therapy. After informed consent, each participant donates a single fresh spot urine sample (about 50 mL) for untargeted metabolomics and proteomics analyses. Researchers will link urine metabolite and protein profiles with clinical data, biopsy results, treatment type (prostatectomy, radiotherapy, chemotherapy, or androgen-deprivation therapy), and subsequent outcomes including efficacy and side effects. The aim is to identify urinary markers that can predict treatment response or the likelihood of adverse effects.
Who should consider this trial
Good fit: Men aged 30–100 with histopathologically confirmed prostate adenocarcinoma who plan to undergo radical prostatectomy, definitive radiotherapy, systemic chemotherapy, or androgen-deprivation therapy and who have not received prior cancer treatment are ideal candidates.
Not a fit: Patients who have already received cancer treatment before enrollment or who have other active, incompletely treated cancers are unlikely to receive benefit from joining this study.
Why it matters
Potential benefit: If successful, urine-based markers could help doctors personalize treatment choices and anticipate side effects for men with prostate cancer.
How similar studies have performed: Previous small studies have reported promising urine metabolite and protein signatures related to prostate cancer diagnosis or prognosis, but findings are preliminary and not yet standard practice.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Subjects who have histopathologically confirmed prostate adenocarcinoma. 2. Subjects who age 30 years to 100 years 3. Subjects who agree to undergo the any of the following four treatments, including radical prostatectomy, definitive prostate radiotherapy, systemic chemotherapy, and androgen deprivation therapy for prostate cancer. 4. Subjects who understand and will comply with the entire study procedures, consent to donate his spot urine (once for 50 ml) for urine metabolomics and proteomic profiling, and agree with subsequent collection and analysis of his clinical information including results of biopsy and the details of treatments and outcomes. (Note: Subjects will be told that the urine metabolomics and proteomics results will not be revealed to them.) Exclusion Criteria: 1. Subjects who have other cancers that have not been curatively treated or are disease-free for only 3 years or less. Subjects who have other genitourinary cancers (urothelial, renal cell, etc) are NOT allowed no matter what the disease-free duration is. However, subjects who have been curatively treated and 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 or proteomics profiles determined by the investigators, such as Cre \> 3.0, HbA1c \> 9.0%, symptomatic heart failure, or other symptomatic metabolic diseases. 3. Subjects who have significant infection or inflammation within 8 weeks of the biopsy. 4. Subjects who are taking medicine(s) that may, deemed by the investigators, substantially affect cell metabolism and proteomics profiles. 5. Subjects who have a life expectancy less than 12 months.
Where this trial is running
Taipei
- National Taiwan University — 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
- Email: mufasachen@gmail.com
- Phone: 886-2-23123456
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.