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

NCT ID: NCT03893929

Last Updated: 2025-05-06

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 5000 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2015-10-07
• Study Completion Date: 2025-12-31

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.

Conditions

Prostate Cancer

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Chinese patients with clinical suspicious of prostate cancer

To identify potential new blood and urine markers for the diagnosis, risk stratification and prognosis prediction for prostate cancer in Chinese population.

New Biological markers for prostate cancer diagnosis and management

Intervention Type: DIAGNOSTIC_TEST

To identify potential new blood and urine markers for the diagnosis, risk stratification and prognosis prediction for prostate cancer in Chinese population.

Interventions

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.

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Chinese University of Hong Kong

OTHER

Sponsor Role: lead

Responsible Party

NG Chi Fai

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Chi Fai Ng, MD

Role: PRINCIPAL_INVESTIGATOR

Chinese University of Hong Kong

Locations

Prince of Wales Hospital

Shatin, , Hong Kong

Site Status: RECRUITING

Countries

Hong Kong

Central Contacts

Chi Fai Ng, MD

Role: CONTACT

ngcf@surgery.cuhk.edu.hk

852-3505-1663

Facility Contacts

Chi Fai NG, MD

Role: primary

ngcf@surgery.cuhk.edu.hk

3505 3953

References

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Haese A, Graefen M, Steuber T, Becker C, Pettersson K, Piironen T, Noldus J, Huland H, Lilja H. Human glandular kallikrein 2 levels in serum for discrimination of pathologically organ-confined from locally-advanced prostate cancer in total PSA-levels below 10 ng/ml. Prostate. 2001 Oct 1;49(2):101-9. doi: 10.1002/pros.1123.

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Other Identifiers

CRE-2015.444

Identifier Type: -

Identifier Source: org_study_id