Clinical trial · Observational
The Investigation of New Biological Markers for Prostate Cancer Diagnosis and Management in Chinese Population
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| New Biological markers for prostate cancer diagnosis and management | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Chinese patients with clinical suspicious of prostate cancer
- description
- To identify potential new blood and urine markers for the diagnosis, risk stratification and prognosis prediction for prostate cancer in Chinese population.
- interventionNames
- Diagnostic Test: New Biological markers for prostate cancer diagnosis and management
Primary outcomes (4)
- measure
- To identify potential new blood markers for the diagnosis for prostate cancer in Chinese population.
- timeFrame
- Baseline (One-time point)
- description
- The application of Kallikrein-2 and \[-2\]-pro PSA in the diagnosis of prostate cancer in Chinese population.
- measure
- To identify potential new blood markers for prognosis prediction for prostate cancer in Chinese population.
- timeFrame
- Baseline (One-time point)
- description
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (13)
- BACKGROUNDNg CF, Chiu PK, Lam NY, Lam HC, Lee KW, Hou SS. The Prostate Health Index in predicting initial prostate biopsy outcomes in Asian men with prostate-specific antigen levels of 4-10 ng/mL. Int Urol Nephrol. 2014 Apr;46(4):711-7. doi: 10.1007/s11255-013-0582-0. Epub 2013 Oct 18. PMID 24136184
- BACKGROUNDGudmundsson J, Sulem P, Gudbjartsson DF, Masson G, Agnarsson BA, Benediktsdottir KR, Sigurdsson A, Magnusson OT, Gudjonsson SA, Magnusdottir DN, Johannsdottir H, Helgadottir HT, Stacey SN, Jonasdottir A, Olafsdottir SB, Thorleifsson G, Jonasson JG, Tryggvadottir L, Navarrete S, Fuertes F, Helfand BT, Hu Q, Csiki IE, Mates IN, Jinga V, Aben KK, van Oort IM, Vermeulen SH, Donovan JL, Hamdy FC, Ng CF, Chiu PK, Lau KM, Ng MC, Gulcher JR, Kong A, Catalona WJ, Mayordomo JI, Einarsson GV, Barkardottir RB, Jonsson E, Mates D, Neal DE, Kiemeney LA, Thorsteinsdottir U, Rafnar T, Stefansson K. A study based on whole-genome sequencing yields a rare variant at 8q24 associated with prostate cancer. Nat Genet. 2012 Dec;44(12):1326-9. doi: 10.1038/ng.2437. Epub 2012 Oct 28. PMID 23104005
- BACKGROUNDRen S, Peng Z, Mao JH, Yu Y, Yin C, Gao X, Cui Z, Zhang J, Yi K, Xu W, Chen C, Wang F, Guo X, Lu J, Yang J, Wei M, Tian Z, Guan Y, Tang L, Xu C, Wang L, Gao X, Tian W, Wang J, Yang H, Wang J, Sun Y. RNA-seq analysis of prostate cancer in the Chinese population identifies recurrent gene fusions, cancer-associated long noncoding RNAs and aberrant alternative splicings. Cell Res. 2012 May;22(5):806-21. doi: 10.1038/cr.2012.30. Epub 2012 Feb 21. PMID 22349460
- BACKGROUNDPatel DA, Presti JC Jr, McNeal JE, Gill H, Brooks JD, King CR. Preoperative PSA velocity is an independent prognostic factor for relapse after radical prostatectomy. J Clin Oncol. 2005 Sep 1;23(25):6157-62. doi: 10.1200/JCO.2005.01.2336. PMID 16135482
- BACKGROUNDD'Amico AV, Chen MH, Roehl KA, Catalona WJ. Preoperative PSA velocity and the risk of death from prostate cancer after radical prostatectomy. N Engl J Med. 2004 Jul 8;351(2):125-35. doi: 10.1056/NEJMoa032975. PMID 15247353