NCT03914391Recruiting
To Identify Potential New Urine Markers for the Screening of Prostate Cancer
Source: ClinicalTrials.gov · Last updated 27 Oct 2026
Brief summary (registry, in English)
Prostate gland is a clinically important male sexual organ and its main function is for the production of semen. Globally, it is the second most common cancer in men globally and is also the fifth cancer cause for death in male. Despite the improvement in the understanding of prostate cancer, the current usage of serum prostate specific antigen (PSA) as a diagnostic marker is still not ideal. Many patients with elevated PSA and then subjected to prostate biopsy were found to have no prostate cancer. Therefore, there is a need to discover new biological markers to improve the current situation in diagnosis and also management of prostate cancer. From the earlier small-scale studies, urinary spermine levels have been shown to correlate well with prostate cancer diagnosis and cancer aggressiveness. Due to its nature, it could provide a more convenient and non-invasive method for detecting prostate cancer. The purpose of this study was to collect urine samples to study the role of potential new urine diagnostic markers (including Spermine and others) for prostate cancer diagnosis.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 10000 (estimated)
- First submitted
- 9 Apr 2019
- Start date
- 16 Jan 2019
- Primary completion date
- 31 Dec 2028
- Lead sponsor
- Chinese University of Hong Kong
- Diseases
- Prostate cancer
- NCT number
- NCT03914391
What you commit to
- Study type: Observational
- Planned participants: 10000
- From 16 Jan 2019 to the primary completion date, 31 Dec 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Patient with recent urinary tract infection within 6 weeks prior to PSA testing and urine collection.
- Patient with recent urethral instrumentation, such as Foley catheter insertion, cystoscopy etc, within 6 weeks prior to PSA testing and urine collection.
- Patient with consumption of 5 alpha reductase inhibitors in past 6 months.
- Patient did not receive any surgery for prostatic pathology
Other
- Patient refused or unable to provide consent for the study
Who the study is looking for
- Adult male patients with age \> 18 years old
- Subject has elevated serum PSA level above 4ng/ml
- Clinical planned for prostatic biopsy.
Age in the registry: 18 years to - · Sex: Male · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Prince of Wales Hospital Coordinator of this site? Confirm its status | Shatin | Hong Kong SAR China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.