Identifying new urine markers for prostate cancer screening
To Identify Potential New Urine Markers for the Screening of Prostate Cancer
This study is trying to find new urine tests that could help men with high PSA levels get a better and easier way to check for prostate cancer.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 10000 (estimated) |
| Ages | 18 Years and up |
| Sex | Male |
| Sponsor | Chinese University of Hong Kong Academic / other |
| Locations | 1 site (Shatin) |
| Trial ID | NCT03914391 on ClinicalTrials.gov |
What this trial studies
This observational study aims to identify new urinary biomarkers that could improve the screening and diagnosis of prostate cancer. Current diagnostic methods, particularly the serum prostate-specific antigen (PSA) test, have limitations, often leading to unnecessary biopsies. By collecting urine samples from adult males with elevated PSA levels, the study will investigate the correlation between urinary spermine levels and prostate cancer diagnosis and aggressiveness. This non-invasive approach could provide a more accurate and convenient method for detecting prostate cancer.
Who should consider this trial
Good fit: Ideal candidates for this study are adult males over 18 years old with elevated serum PSA levels above 4 ng/ml who are clinically planned for a prostate biopsy.
Not a fit: Patients with recent urinary tract infections, recent urethral instrumentation, or those on specific medications may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to a more reliable and non-invasive method for diagnosing prostate cancer, reducing unnecessary biopsies.
How similar studies have performed: Previous studies have shown promise in using urinary biomarkers for cancer diagnosis, suggesting potential success for this novel approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Adult male patients with age \> 18 years old 2. Subject has elevated serum PSA level above 4ng/ml 3. Clinical planned for prostatic biopsy. Exclusion Criteria: 1. Patient with recent urinary tract infection within 6 weeks prior to PSA testing and urine collection. 2. Patient with recent urethral instrumentation, such as Foley catheter insertion, cystoscopy etc, within 6 weeks prior to PSA testing and urine collection. 3. Patient with consumption of 5 alpha reductase inhibitors in past 6 months. 4. Patient did not receive any surgery for prostatic pathology 5. Patient refused or unable to provide consent for the study
Where this trial is running
Shatin
- Prince of Wales Hospital — Shatin, Hong Kong (Recruiting)
Study contacts
- Principal investigator: Chi Fai Ng, MD — The Chinese University if Hong Kong
- Study coordinator: Chi Fai Ng, MD
- Email: ngcf@surgery.cuhk.edu.hk
- Phone: 852-3505-2625
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.