The Investigation of New Biological Markers for Prostate Cancer Diagnosis and Management in Chinese Population

Recruiting

• Conditions: Prostate Cancer
• Interventions: Diagnostic Test: New Biological markers for prostate cancer diagnosis and management

• Registration Number: NCT03893929
• Lead Sponsor: Chinese University of Hong Kong

Brief Summary

Prostate cancer (PC) is highly prevalent worldwide and is currently the 3rd most commonly diagnosed prostate cancer in Hong Kong male population with more than 1600 new cases diagnosed per year. 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. Moreover, the current risk stratification system, based on PSA, clinical staging and Gleason score is of only limited value, as a significant proportion of patients with high-risk nonmetastatic PC have incurable disease due to locally advanced and/or occult metastasis,, whilst others with indolent disease may never suffer morbidity or mortality from PC.

Therefore, in order to improve patient management and outcome, there is a need to identify newer markers and also validate some potential markers in Chinese population.

Detailed Description

Prostate cancer (PC) is highly prevalent worldwide and is currently the 3rd most commonly diagnosed prostate cancer in Hong Kong male population with more than 1600 new cases diagnosed per year. Even with widely used serum Prostate Specific Antigen (PSA) diagnostic testing, more than 50% men with newly diagnosed PC are deemed to have highrisk disease. 1 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. 2 Moreover, the current risk stratification system, based on PSA, clinical staging and Gleason score is of only limited value, as a significant proportion of patients with high-risk nonmetastatic PC have incurable disease due to locally advanced and/or occult metastasis, whilst others with indolent disease may never suffer morbidity or mortality from PC. Furthermore, high-risk (non-metastatic) prostate cancer (thus defined) exhibits a high degree of heterogeneity of response to current treatment protocols. Lastly, the characteristics of prostate cancer in our Chinese population might not be the same as those in Caucasian. 3,4 Several single biomarkers have been introduced in an attempt to address the clinical need for better prognostic tests in prostate cancer. For example, increased pre-operative PSA velocity (≥2ng/ml/per year) has been associated with increased risk of recurrence after prostatectomy5 and mortality6, as have increased serum levels of Kallikrein-2 and \[-2\]-pro PSA.7-10 Pre-operative levels of prostate cancer gene 3 (PCA3) have been found to be elevated in tumours \>0.5cc, 11 however these findings could not be confirmed in recent work.12 Therefore, in order to improve patient management and outcome, there is therefore an urgent need to improve our ability to identify newer markers and also validate some potential markers in our population.

Study Timeline

• Study Start: 2015-10-07
• Study First Submitted: 2019-03-26
• Study First Submitted QC: 2019-03-26
• Study First Posted: 2019-03-28
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-04
• Last Update Posted: 2025-05-06
• Primary Completion: 2025-12-31
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Male
• Target Recruitment: 5000

Inclusion Criteria

1. Adult Chinese male patients with age > 18 years old
2. Clinical suspected to have prostate cancer, based on abnormal digital rectal examination or elevated serum PSA level

Exclusion Criteria

1. Patient refused or unable to provide consent for the study

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Chinese patients with clinical suspicious of prostate cancer	New Biological markers for prostate cancer diagnosis and management	To identify potential new blood and urine markers for the diagnosis, risk stratification and prognosis prediction for prostate cancer in Chinese population.

Primary Outcome Measures

Name	Time	Method
To identify potential new urine markers for prognosis prediction for prostate cancer in Chinese population.	Baseline (One-time point)	The role of urine spermine in the prognosis of prostate cancer
To identify potential new urine markers for the diagnosis for prostate cancer in Chinese population.	Baseline (One-time point)	The role of urine spermine in the diagnosis of prostate cancer
To identify potential new blood markers for prognosis prediction for prostate cancer in Chinese population.	Baseline (One-time point)	The application of Kallikrein-2 and \[-2\]-pro PSA in the prognosis of prostate cancer in Chinese population.
To identify potential new blood markers for the diagnosis for prostate cancer in Chinese population.	Baseline (One-time point)	The application of Kallikrein-2 and \[-2\]-pro PSA in the diagnosis of prostate cancer in Chinese population.

Trial Locations

Locations (1)

Prince of Wales Hospital; 🇭🇰 Shatin, Hong Kong