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NCT Number: NCT03893929

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

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.

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Key information

Age range

18 year and older

Sex eligibility

Male

Study type

Observational

Primary location

Prince of Wales Hospital

Shatin, Hong Kong

Location status: Recruiting

Location contact

Chi Fai NG, MD

CONTACT

[email protected]

3505 3953

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Patient refused or unable to provide consent for the study

Treatment and study plan

New Biological markers for prostate cancer diagnosis and management

Diagnostic Test

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

Primary outcomes

  1. To identify potential new blood markers for the diagnosis for prostate cancer in Chinese population.

    Time frame: Baseline (One-time point)

    The application of Kallikrein-2 and [-2]-pro PSA in the diagnosis of prostate cancer in Chinese population.

  2. To identify potential new blood markers for prognosis prediction for prostate cancer in Chinese population.

    Time frame: Baseline (One-time point)

    The application of Kallikrein-2 and [-2]-pro PSA in the prognosis of prostate cancer in Chinese population.

  3. To identify potential new urine markers for the diagnosis for prostate cancer in Chinese population.

    Time frame: Baseline (One-time point)

    The role of urine spermine in the diagnosis of prostate cancer

  4. To identify potential new urine markers for prognosis prediction for prostate cancer in Chinese population.

    Time frame: Baseline (One-time point)

    The role of urine spermine in the prognosis of prostate cancer

Study contacts

Contact information is provided by the study sponsor or research team.

Chi Fai Ng, MD

CONTACT

[email protected]

852-3505-1663

Sponsors and collaborators

Lead sponsor

Chinese University of Hong Kong

Other

Registry information

Important dates

Study start
2015
Primary completion
2025
Study completion
2025
First posted
Mar 28, 2019
Registry last updated
May 6, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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