NCT03914391 To Identify Potential New Urine Markers for the Screening of Prostate Cancer
| NCT ID | NCT03914391 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Chinese University of Hong Kong |
| Condition | Prostate Cancer |
| Study Type | OBSERVATIONAL |
| Enrollment | 10,000 participants |
| Start Date | 2019-01-16 |
| Primary Completion | 2025-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 10,000 participants in total. It began in 2019-01-16 with a primary completion date of 2025-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility 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
Contact & Investigator
Chi Fai Ng, MD
PRINCIPAL INVESTIGATOR
The Chinese University if Hong Kong
Frequently Asked Questions
Who can join the NCT03914391 clinical trial?
This trial is open to male participants only, aged 18 Years or older, studying Prostate Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT03914391 currently recruiting?
Yes, NCT03914391 is actively recruiting participants. Contact the research team at ngcf@surgery.cuhk.edu.hk for enrollment information.
Where is the NCT03914391 trial being conducted?
This trial is being conducted at Shatin, Hong Kong.
Who is sponsoring the NCT03914391 clinical trial?
NCT03914391 is sponsored by Chinese University of Hong Kong. The principal investigator is Chi Fai Ng, MD at The Chinese University if Hong Kong. The trial plans to enroll 10,000 participants.
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