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

Prostate Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03914391
• Other study ID #: CRE-2018.376
• Status: Recruiting
• Start date: January 16, 2019
• Est. completion date: December 31, 2025

Study information

• Verified date: January 2024
• Source: Chinese University of Hong Kong
• Contact: Chi Fai Ng, MD
• Phone: 852-3505-2625
• Email: ngcf[@]surgery.cuhk.edu.hk
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Description:

Prostate cancer (PC) is highly prevalent worldwide and is the second most commonly diagnosed cancer in men globally and is the 5th leading cause of cancer death in men. 1 In some Asian areas, even n with widely used serum Prostate Specific Antigen (PSA) diagnostic testing, more than 50% men with newly diagnosed PC are deemed to have high risk disease. 2 However, the current use of serum PSA as a diagnostic marker is unsatisfactory. Many patients has elevated serum PSA is actually due to other causes and also the level of serum PSA do not correlate with the staging and grading of prostate cancer. 3 Moreover, the use of serum PSA required blood taking which is invasive and non-convenience for large scale screening. Therefore, newer markers is needed for more simple and accurate diagnosis of prostate cancer. One example of such cancer biomarkers are natural polyamines. Interests on these analytes have been starting in 1971 when Russell reported a considerable increase of urinary polyamines such as putrescine (Put), spermidine (Spd) and spermine (Spm) in patients with various types of solid tumors and leukaemias. 4 Afterwards, polyamine studies focusing on specific cancers continued, like cervical cancer, 5 colorectal cancer 6 and breast cancer, 7 etc. In investigators' recent study, investigators have explored the potential roles of urinary polyamines as prostate cancer biomarkers were evaluated. Patients with prostate cancer (PCa), benign prostatic hyperplasia (BPH) patients and healthy controls (HC) showing PSA>4.0ng/ml were enrolled in the study.8 Their urine samples were obtained, and the urinary levels of Put, Spd, Spm were determined by ultra-high-performance liquid chromatography coupled with triple quadrupole mass spectrometer (UPLC-MS/MS). Receiver operating characteristics (ROC) curve and Student's t- test were used to evaluate their diagnostic accuracies. Among the three biogenic polyamines, Spm had demonstrated a good diagnostic performance when comparing their levels in PCa patients with BPH patients (1.47 in PCa vs 5.87 in BPH; p<0.0001). The results were in accordance with transrectal ultrasound prostatic biopsy (TRUSPB) results, with an area under curve (AUC) value of 0.83±0.03. Therefore, urinary Spm could have a potential to serve as a novel PCa diagnostic biomarker, which in turn could help to address the limited sensitivity and specificity problem of serum PSA test. Therefore, investigators would like to have a larger scale study, with inclusion of subjects from different geographic locations, to further assess the correlation spermine and other potential newer urine markers with diagnosis of prostate cancer and investigate their role as a potential non-invasive marker for prostate cancer risk stratification and prognosis prediction.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10000
• Est. completion date: December 31, 2025
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Locations

Country	Name	City	State
Hong Kong	Prince of Wales Hospital	Shatin

Sponsors (1)

Lead Sponsor	Collaborator
Chinese University of Hong Kong

Country where clinical trial is conducted

Hong Kong, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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)