To Identify Potential New Urine Markers for the Screening of Prostate Cancer
Recruiting · NCT03914391 · Observational (researchers observe without assigning treatment) · Lead sponsor: Chinese University of Hong Kong
View the official record on ClinicalTrials.gov →What this trial is about
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.
Who can take part
Inclusion criteria
- Adult male patients with age \> 18 years old
- Subject has elevated serum PSA level above 4ng/ml
- Clinical planned for prostatic biopsy.
Exclusion criteria
- 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
- Patient refused or unable to provide consent for the study
Where it is running
1 location listed.
- Prince of Wales Hospital - Shatin, Hong Kong