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

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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03893929
Enrollment
5000
Registered
2019-03-28
Start date
2015-10-07
Completion date
2025-12-31
Last updated
2025-05-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prostate Cancer

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.

Interventions

DIAGNOSTIC_TESTNew 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.

Sponsors

Chinese University of Hong Kong
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
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.
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 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 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

Countries

Hong Kong

Contacts

Primary ContactChi Fai Ng, MD
ngcf@surgery.cuhk.edu.hk852-3505-1663

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026