Ignite Creation Date:
2024-05-06 @ 12:58 PM
Last Modification Date:
2024-10-26 @ 1:06 PM
Study NCT ID:
NCT03893929
Status:
RECRUITING
Last Update Posted:
2024-01-23
First Post:
2019-03-26
Brief Title:
The Investigation of New Biological Markers for Prostate Cancer Diagnosis and Management in Chinese Population
Sponsor:
Chinese University of Hong Kong
Organization:
Chinese University of Hong Kong
Study Overview
Official Title:
The Investigation of New Biological Markers for Prostate Cancer Diagnosis and Management in Chinese Population
Status:
RECRUITING
Status Verified Date:
2024-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 andor 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
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 andor 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 34 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 2ngmlper year has been associated with increased risk of recurrence after prostatectomy5 and mortality6 as have increased serum levels of Kallikrein-2 and -2-pro PSA7-10 Pre-operative levels of prostate cancer gene 3 PCA3 have been found to be elevated in tumours 05cc 11 however these findings could not be confirmed in recent work12 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None