To Identify Potential New Urine Markers for the Screening of Prostate Cancer

Recruiting now

Conditions studied: Prostate Cancer

In brief

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.

Key facts

Study ID

NCT03914391

Run by

Chinese University of Hong Kong

People needed

10000

Starts

2019-01-16

Expected to finish

2025-12-31

Last updated by the study team

2025-05-06

Who can join

Age: 18 and older. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• Adult male patients with age > 18 years old
• Subject has elevated serum PSA level above 4ng/ml
• Clinical planned for prostatic biopsy.

You may not qualify if…

• 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

• Prince of Wales Hospital — Shatin, Hong Kong (enrolling)

Full record on ClinicalTrials.gov

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