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

NCT03914391 | Recruiting

• 1 other identifier: CRE-2018.376
• Study Type: observational
• Target: 10,000
• Locations: 1 country
• Sites: 1

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.

Conditions

Prostate Cancer

Outcome Measures

Primary Outcomes (2)

• To investigate the role of urine spermine in the diagnosis of prostate cancer

  Fresh urine will be collected for liquid chromatography and mass spectrometry to detect the concentration of spermine in urine. Then the The correlation between the concentration of urine spermine and serum PSA level and pathological result will be assessed.

  Baseline (one-time point)

• To investigate the role of urine spermine in prognostic prediction of prostate cancer

  Fresh urine will be collected for liquid chromatography and mass spectrometry to detect the concentration of spermine in urine. Then the The correlation between the concentration of urine spermine and pathological result and serum PSA level will be assessed.

  Baseline (one-time point)

Eligibility Criteria

• Age: 18 Years+
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients who has elevated serum PSA, i.e. \> 4ng/ml, and planned for prostatic biopsy.

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

Sponsors & Collaborators

• Chinese University of Hong Kong: lead

Study Sites (1)

Prince of Wales Hospital

Shatin, Hong Kong

RECRUITING

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Officials

• Chi Fai Ng, MD

  The Chinese University if Hong Kong

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Chi Fai Ng, MD

CONTACT

852-3505-2625; ngcf@surgery.cuhk.edu.hk

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: April 9, 2019
• First Posted: April 16, 2019
• Study Start: January 16, 2019
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: May 6, 2025

Record last verified: 2025-05

Locations

HK (1)