Clinical trial NCT03893929: The Investigation of New Biological Markers for Prostate Cancer Diagnosis and Management in Chinese Population
Official title: The Investigation of New Biological Markers for Prostate Cancer Diagnosis and Management in Chinese Population
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Prostate Cancer
Lead sponsor: Chinese University of Hong Kong
Sponsor class: OTHER
First posted: 2019-03-28
Enrollment: 5000
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: A total of 5000 Chinese patients with clinical suspicious of prostate cancer and pending for transrectal ultrasound (TRUS) guided prostate biopsy for assessment will be invited to participate in this study.

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.

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

Primary outcomes:
measure: To identify potential new blood markers for the diagnosis for prostate cancer in Chinese population.
timeFrame: Baseline (One-time point)
measure: To identify potential new blood markers for prognosis prediction for prostate cancer in Chinese population.
timeFrame: Baseline (One-time point)
measure: To identify potential new urine markers for the diagnosis for prostate cancer in Chinese population.
timeFrame: Baseline (One-time point)
measure: To identify potential new urine markers for prognosis prediction for prostate cancer in Chinese population.
timeFrame: Baseline (One-time point)
Secondary outcomes:
Other outcomes:
Locations:
city: Shatin
country: Hong Kong
facility: Prince of Wales Hospital
Study officials:
affiliation: Chinese University of Hong Kong
name: Chi Fai Ng, MD
role: PRINCIPAL_INVESTIGATOR
References:
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