Prostate CancerNCT03911999
Exosomal microRNA in Predicting the Aggressiveness of Prostate Cancer in Chinese Patients
An observational study of Prostate Cancer, run by Chinese University of Hong Kong at 1 site in Hong Kong.
Trial summary
The prostate gland is a clinically important male accessory sex gland and vital for its production of semen. Prostate cancer (PCa) is now ranked 3th in annual incidence of male cancer and ranked 5th for cancer-related death in men in Hong Kong which accounts for about 10.9 deaths per 100,000 persons. Read more about this study
- Who is it for?
- Ages 45 years and older, men only
- Conditions the study is for
- Prostate Cancer
- How many people
- 180 participants
- Where
- 1 siteHong Kong
- Study dates
- 3 May 2018to 31 Dec 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Study population: For non prostate cancer group, there is no specific time limit for urine collection. For prostate cancer group, urine will be collected prior to prostatectomy.
Who may be able to join
- For non prostate cancer group
- Male subject with age 45 or above
- No clinical evidence of PCa, serum PSA <4 ng/dl and normal digital rectal examination.
- For prostate cancer group
- Male subject with age 45 or above
- Clinically diagnosed to have localized PCa and planned for radical prostatectomy
- No prior systemic therapy for PCa used, including hormonal or chemotherapy.
Who cannot join
- History of medications usage that can affect serum PSA levels within 6 months of study enrolment.
- History of active urinary tract infection within 1 month of study enrolment.
- History of invasive prostate / bladder treatments within 6 months of study enrolment.
- History of concurrent renal/bladder cancer within 6 months of study enrolment.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: To Investigate the Diagnostic Accuracy of Exosomal microRNA in Predicting the Aggressiveness of Prostate Cancer in Chinese Patients
The prostate gland is a clinically important male accessory sex gland and vital for its production of semen. Prostate cancer (PCa) is now ranked 3th in annual incidence of male cancer and ranked 5th for cancer-related death in men in Hong Kong which accounts for about 10.9 deaths per 100,000 persons. Its incidence is rising rapidly, almost tripled in the past 10 years. Fortunately, with the improvement in awareness of the disease and also increasing use of serum prostate specific antigen for early case identification, many patients are diagnosed at an earlier stage. However, unlike other malignancy, PCa is characterized by its slow progression nature. Therefore, some patients with low grade low volume disease might never suffered from PCa related complications or mortality. As a result, recent year, there is an increase use a more conservative approach, active surveillance (AS), for management of early prostate cancer. The principle of AS is selecting patients with low risk of disease and offered them regular monitoring, instead of radical local therapy, unless patient's cancer was noticed to progressing. By using this approach, patients might avoid possible complications related to treatment. Currently, people could use some clinical parameters, imaging and repeated prostate biopsy to assess and monitor the aggressiveness/ progression of PCa. However, these parameters suffered from defects, such as low correlation to the final PCa pathology or not readily repeatable for patients. Therefore, there is a need to identify more easy, safe and repeatable monitoring of the aggressiveness of prostate cancer.
Exosome is genetic materials secreted by cells and could be measured in various body fluid. There are some studies suggested it is a potential marker for PCa diagnosis and monitoring. The aim of this study is to investigate the relationship of urinary exosome and the aggressiveness of prostate cancer.
Read the detailed description
Prostate cancer (PCa) is the third most common male cancer in Hong Kong. While the use of serum PSA has greatly improved the proportion of patients diagnosed at localized /early stage, there are also problems of overdiagnosis and overtreatment. Unfortunately, there was still no ideal markers that could help to predict the aggressiveness of PCa, especially in Chinese population. Exosome is an important media for cell-cell interaction. The content of exomsomes, including microRNAs, are believed to have important roles in PCa development and progression, and might also serve as potential markers in PCa management. Therefore, investigators would like to explore the role of exosomal microRNA in the prediction of tumour aggressiveness in local Chinese PCa patients. This is a prospective study divided into two parts. Subjects will be recruited consecutively from two hospitals.
In Part I of the study (Candidate exosomal microRNA discovery and selection), a total of 60 patients from three groups (non-cancer, pathologically insignificant cancer and significant cancer patients) will be recruited. First portion of urine will be collected from them. For Group 2\&3 patients, they are patients with clinically localized prostate cancer and planned for radical prostatectomy, urine will be collected before surgery for these two groups. Exosomal RNA will be extracted from urine and microRNAs expression profiles will be determined by next-generation sequencing. Candidate exosomal microRNAs that could differentiate pathological insignificant and significant PCa will be identified for Part II study.
In Part II study (Candidate exosomal microRNAs validation), 180 patients with localized prostate cancer, planned for radical prostatectomy will be recruited. Urine will be again collected before surgery and the level of candidate exosomal microRNAs for each patient will be assessed. The diagnostic accuracy of these candidate exosomal microRNAs on predicting pathological insignificant cancer and also correlation with the final pathology will be assessed.
The primary tasks for Part I study is the identification of potential exosomal microRNAs that could differentiate pathologically insignificant and significant PCa.
The primary task for Part II study is the validation of the ability of those candidate exosomal microRNAs in differentiating pathological insignificant and significant PCa.
- Conditions
- Prostate Cancer
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Non-prostate cancer subjects | No clinical evidence of prostate cancer | |
| Subjects with pathologically insignificant prostate cancer | Insignificant prostate cancers were organ confined with tumor volumes less than 0.5 cc and Gleason score < 7. | |
| Subjects with pathologically significant prostate cancer | Significant cancers are those with either Gleason score > 7, evidences of extra-prostatic extension with positive margins, or seminal vesicles / lymph nodes involvement. |
What is being measured
The primary outcome is the main question the study is designed to answer.
To compare the differences in microRNA expression between non-prostate cancer subjects, pathologically insignificant and significant prostate cancer patients.
Urine will be collected prior to surgery. The urine sample will then be handled immediately for exosomal RNA extraction (refer to specific methodology). The extracted exosomal RNA would then be stored for next generation sequencing (NGS). Results of the 3 groups will then be compared, with reference to literatures findings. Candidate microRNAs that can differentiate between pathologically significant and insignificant cancer will be selected for Part II study.
Measured: Baseline, one-time point
To assess the accuracy of selected microRNAs for the differentiation of patients with pathologically insignificant and significant prostate cancer after radical prostatectomy
Urine will be collected prior to surgery. The urine sample will then be handled immediately for exosomal RNA extraction (refer to specific methodology). The extracted exosomal RNA would then be stored for next generation sequencing (NGS). Results of the 3 groups will then be compared, with reference to literatures findings. Candidate microRNAs that can differentiate betten pathologically significant and insignificant cancer will be selected for Part II study.The preoperative patients and disease parameters, including age, clinical staging, serum PSA level, prostatic biopsy results, MRI findings, together with the prostatectomy pathology will be collected for subsequent data analysis.
Measured: Baseline, one-time point
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2019
- Study start3 May 2018
- Primary completion15 Nov 2020
- Study completion31 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (18)Papers the sponsor has linked to this study.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- More trials run by Chinese University of Hong KongThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 180 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chinese University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, NG Chi Fai, Chinese University of Hong Kong
- Investigators
- Chi Fai Ng, MD, Principal investigator, Chinese University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03911999
- Sponsor's protocol ID
- CRE-2018.063
- Status last verified
- Oct 2026
- First submitted
- 10 Apr 2019
- Last updated
- 27 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Strope SA, Andriole GL. Prostate cancer screening: current status and future perspectives. Nat Rev Urol. 2010 Sep;7(9):487-93. doi: 10.1038/nrurol.2010.120.
PubMed 20818326Epstein JI, Walsh PC, Carmichael M, Brendler CB. Pathologic and clinical findings to predict tumor extent of nonpalpable (stage T1c) prostate cancer. JAMA. 1994 Feb 2;271(5):368-74.
PubMed 7506797Ploussard G, Epstein JI, Montironi R, Carroll PR, Wirth M, Grimm MO, Bjartell AS, Montorsi F, Freedland SJ, Erbersdobler A, van der Kwast TH. The contemporary concept of significant versus insignificant prostate cancer. Eur Urol. 2011 Aug;60(2):291-303. doi: 10.1016/j.eururo.2011.05.006. Epub 2011 May 17.
PubMed 21601982McKiernan J, Donovan MJ, O'Neill V, Bentink S, Noerholm M, Belzer S, Skog J, Kattan MW, Partin A, Andriole G, Brown G, Wei JT, Thompson IM Jr, Carroll P. A Novel Urine Exosome Gene Expression Assay to Predict High-grade Prostate Cancer at Initial Biopsy. JAMA Oncol. 2016 Jul 1;2(7):882-9. doi: 10.1001/jamaoncol.2016.0097.
PubMed 27032035Dinh KT, Mahal BA, Ziehr DR, Muralidhar V, Chen YW, Viswanathan VB, Nezolosky MD, Beard CJ, Choueiri TK, Martin NE, Orio PF, Sweeney CJ, Trinh QD, Nguyen PL. Incidence and Predictors of Upgrading and Up Staging among 10,000 Contemporary Patients with Low Risk Prostate Cancer. J Urol. 2015 Aug;194(2):343-9. doi: 10.1016/j.juro.2015.02.015. Epub 2015 Feb 11.
PubMed 25681290Chiu PK, Lai FM, Teoh JY, Lee WM, Yee CH, Chan ES, Hou SM, Ng CF. Prostate Health Index and %p2PSA Predict Aggressive Prostate Cancer Pathology in Chinese Patients Undergoing Radical Prostatectomy. Ann Surg Oncol. 2016 Aug;23(8):2707-14. doi: 10.1245/s10434-016-5183-6. Epub 2016 Mar 10.
PubMed 26965697Schiffer E. Biomarkers for prostate cancer. World J Urol. 2007 Dec;25(6):557-62. doi: 10.1007/s00345-007-0203-6. Epub 2007 Aug 10.
PubMed 17690889Ng CF, Yeung R, Chiu PK, Lam NY, Chow J, Chan B. The role of urine prostate cancer antigen 3 mRNA levels in the diagnosis of prostate cancer among Hong Kong Chinese patients. Hong Kong Med J. 2012 Dec;18(6):459-65.
PubMed 23223645Laxman B, Tomlins SA, Mehra R, Morris DS, Wang L, Helgeson BE, Shah RB, Rubin MA, Wei JT, Chinnaiyan AM. Noninvasive detection of TMPRSS2:ERG fusion transcripts in the urine of men with prostate cancer. Neoplasia. 2006 Oct;8(10):885-8. doi: 10.1593/neo.06625.
PubMed 17059688Ren 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.
PubMed 22349460Gudmundsson 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.
PubMed 23104005Wang G, Chan ES, Kwan BC, Li PK, Yip SK, Szeto CC, Ng CF. Expression of microRNAs in the urine of patients with bladder cancer. Clin Genitourin Cancer. 2012 Jun;10(2):106-13. doi: 10.1016/j.clgc.2012.01.001. Epub 2012 Mar 3.
PubMed 22386240Kumar B, Lupold SE. MicroRNA expression and function in prostate cancer: a review of current knowledge and opportunities for discovery. Asian J Androl. 2016 Jul-Aug;18(4):559-67. doi: 10.4103/1008-682X.177839.
PubMed 27056344Endzelins E, Melne V, Kalnina Z, Lietuvietis V, Riekstina U, Llorente A, Line A. Diagnostic, prognostic and predictive value of cell-free miRNAs in prostate cancer: a systematic review. Mol Cancer. 2016 May 18;15(1):41. doi: 10.1186/s12943-016-0523-5.
PubMed 27189160Yu S, Wang X, Ng CF, Chen S, Chan FL. ERRgamma suppresses cell proliferation and tumor growth of androgen-sensitive and androgen-insensitive prostate cancer cells and its implication as a therapeutic target for prostate cancer. Cancer Res. 2007 May 15;67(10):4904-14. doi: 10.1158/0008-5472.CAN-06-3855.
PubMed 17510420
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- To Investigate the Diagnostic Accuracy of Exosomal microRNA in Predicting the Aggressiveness of Prostate Cancer in Chinese Patients
- ClinicalTrials.gov ID
- NCT03911999
- Acronym / sponsor ID
- CRE-2018.063
- Conditions
- Prostate Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 180 participants (actual)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Study start
- 3 May 2018 (actual)
- Primary completion
- 15 Nov 2020 (actual)
- Study completion
- 31 Dec 2020 (actual)
- First posted
- 11 Apr 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The prostate gland is a clinically important male accessory sex gland and vital for its production of semen. Prostate cancer (PCa) is now ranked 3th in annual incidence of male cancer and ranked 5th for cancer-related death in men in Hong Kong which accounts for about 10.9 deaths per 100,000 persons. Its incidence is rising rapidly, almost tripled in the past 10 years. Fortunately, with the improvement in awareness of the disease and also increasing use of serum prostate specific antigen for early case identification, many patients are diagnosed at an earlier stage. However, unlike other malignancy, PCa is characterized by its slow progression nature. Therefore, some patients with low grade low volume disease might never suffered from PCa related complications or mortality. As a result, recent year, there is an increase use a more conservative approach, active surveillance (AS), for management of early prostate cancer. The principle of AS is selecting patients with low risk of disease and offered them regular monitoring, instead of radical local therapy, unless patient's cancer was noticed to progressing. By using this approach, patients might avoid possible complications related to treatment. Currently, people could use some clinical parameters, imaging and repeated prostate biopsy to assess and monitor the aggressiveness/ progression of PCa. However, these parameters suffered from defects, such as low correlation to the final PCa pathology or not readily repeatable for patients. Therefore, there is a need to identify more easy, safe and repeatable monitoring of the aggressiveness of prostate cancer.
Exosome is genetic materials secreted by cells and could be measured in various body fluid. There are some studies suggested it is a potential marker for PCa diagnosis and monitoring. The aim of this study is to investigate the relationship of urinary exosome and the aggressiveness of prostate cancer.
Detailed description
Prostate cancer (PCa) is the third most common male cancer in Hong Kong. While the use of serum PSA has greatly improved the proportion of patients diagnosed at localized /early stage, there are also problems of overdiagnosis and overtreatment. Unfortunately, there was still no ideal markers that could help to predict the aggressiveness of PCa, especially in Chinese population. Exosome is an important media for cell-cell interaction. The content of exomsomes, including microRNAs, are believed to have important roles in PCa development and progression, and might also serve as potential markers in PCa management. Therefore, investigators would like to explore the role of exosomal microRNA in the prediction of tumour aggressiveness in local Chinese PCa patients. This is a prospective study divided into two parts. Subjects will be recruited consecutively from two hospitals.
In Part I of the study (Candidate exosomal microRNA discovery and selection), a total of 60 patients from three groups (non-cancer, pathologically insignificant cancer and significant cancer patients) will be recruited. First portion of urine will be collected from them. For Group 2\&3 patients, they are patients with clinically localized prostate cancer and planned for radical prostatectomy, urine will be collected before surgery for these two groups. Exosomal RNA will be extracted from urine and microRNAs expression profiles will be determined by next-generation sequencing. Candidate exosomal microRNAs that could differentiate pathological insignificant and significant PCa will be identified for Part II study.
In Part II study (Candidate exosomal microRNAs validation), 180 patients with localized prostate cancer, planned for radical prostatectomy will be recruited. Urine will be again collected before surgery and the level of candidate exosomal microRNAs for each patient will be assessed. The diagnostic accuracy of these candidate exosomal microRNAs on predicting pathological insignificant cancer and also correlation with the final pathology will be assessed.
The primary tasks for Part I study is the identification of potential exosomal microRNAs that could differentiate pathologically insignificant and significant PCa.
The primary task for Part II study is the validation of the ability of those candidate exosomal microRNAs in differentiating pathological insignificant and significant PCa.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Non-prostate cancer subjects | – | –No clinical evidence of prostate cancer |
| Subjects with pathologically insignificant prostate cancer | – | –Insignificant prostate cancers were organ confined with tumor volumes less than 0.5 cc and Gleason score < 7. |
| Subjects with pathologically significant prostate cancer | – | –Significant cancers are those with either Gleason score > 7, evidences of extra-prostatic extension with positive margins, or seminal vesicles / lymph nodes involvement. |
Who may qualify
- Ages
- 45 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- For non prostate cancer group, there is no specific time limit for urine collection. For prostate cancer group, urine will be collected prior to prostatectomy.
Key inclusion criteria (7 listed)
- For non prostate cancer group
- For prostate cancer group
Key exclusion criteria (4 listed)
- History of medications usage that can affect serum PSA levels within 6 months of study enrolment.
- History of active urinary tract infection within 1 month of study enrolment.
- History of invasive prostate / bladder treatments within 6 months of study enrolment.
- History of concurrent renal/bladder cancer within 6 months of study enrolment.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
To compare the differences in microRNA expression between non-prostate cancer subjects, pathologically insignificant and significant prostate cancer patients.
Time frame: Baseline, one-time point
Urine will be collected prior to surgery. The urine sample will then be handled immediately for exosomal RNA extraction (refer to specific methodology). The extracted exosomal RNA would then be stored for next generation sequencing (NGS). Results of the 3 groups will then be compared, with reference to literatures findings. Candidate microRNAs that can differentiate between pathologically significant and insignificant cancer will be selected for Part II study.
To assess the accuracy of selected microRNAs for the differentiation of patients with pathologically insignificant and significant prostate cancer after radical prostatectomy
Time frame: Baseline, one-time point
Urine will be collected prior to surgery. The urine sample will then be handled immediately for exosomal RNA extraction (refer to specific methodology). The extracted exosomal RNA would then be stored for next generation sequencing (NGS). Results of the 3 groups will then be compared, with reference to literatures findings. Candidate microRNAs that can differentiate betten pathologically significant and insignificant cancer will be selected for Part II study.The preoperative patients and disease parameters, including age, clinical staging, serum PSA level, prostatic biopsy results, MRI findings, together with the prostatectomy pathology will be collected for subsequent data analysis.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2026.
- Background: PubMed 20818326Strope SA, Andriole GL. Prostate cancer screening: current status and future perspectives. Nat Rev Urol. 2010 Sep;7(9):487-93. doi: 10.1038/nrurol.2010.120.
- Background: PubMed 7506797Epstein JI, Walsh PC, Carmichael M, Brendler CB. Pathologic and clinical findings to predict tumor extent of nonpalpable (stage T1c) prostate cancer. JAMA. 1994 Feb 2;271(5):368-74.
- Background: PubMed 21601982Ploussard G, Epstein JI, Montironi R, Carroll PR, Wirth M, Grimm MO, Bjartell AS, Montorsi F, Freedland SJ, Erbersdobler A, van der Kwast TH. The contemporary concept of significant versus insignificant prostate cancer. Eur Urol. 2011 Aug;60(2):291-303. doi: 10.1016/j.eururo.2011.05.006. Epub 2011 May 17.
- Background: PubMed 27032035McKiernan J, Donovan MJ, O'Neill V, Bentink S, Noerholm M, Belzer S, Skog J, Kattan MW, Partin A, Andriole G, Brown G, Wei JT, Thompson IM Jr, Carroll P. A Novel Urine Exosome Gene Expression Assay to Predict High-grade Prostate Cancer at Initial Biopsy. JAMA Oncol. 2016 Jul 1;2(7):882-9. doi: 10.1001/jamaoncol.2016.0097.
- Background: PubMed 25681290Dinh KT, Mahal BA, Ziehr DR, Muralidhar V, Chen YW, Viswanathan VB, Nezolosky MD, Beard CJ, Choueiri TK, Martin NE, Orio PF, Sweeney CJ, Trinh QD, Nguyen PL. Incidence and Predictors of Upgrading and Up Staging among 10,000 Contemporary Patients with Low Risk Prostate Cancer. J Urol. 2015 Aug;194(2):343-9. doi: 10.1016/j.juro.2015.02.015. Epub 2015 Feb 11.
- Background: PubMed 26965697Chiu PK, Lai FM, Teoh JY, Lee WM, Yee CH, Chan ES, Hou SM, Ng CF. Prostate Health Index and %p2PSA Predict Aggressive Prostate Cancer Pathology in Chinese Patients Undergoing Radical Prostatectomy. Ann Surg Oncol. 2016 Aug;23(8):2707-14. doi: 10.1245/s10434-016-5183-6. Epub 2016 Mar 10.
- Background: PubMed 17690889Schiffer E. Biomarkers for prostate cancer. World J Urol. 2007 Dec;25(6):557-62. doi: 10.1007/s00345-007-0203-6. Epub 2007 Aug 10.
- Background: PubMed 23223645Ng CF, Yeung R, Chiu PK, Lam NY, Chow J, Chan B. The role of urine prostate cancer antigen 3 mRNA levels in the diagnosis of prostate cancer among Hong Kong Chinese patients. Hong Kong Med J. 2012 Dec;18(6):459-65.
- Background: PubMed 17059688Laxman B, Tomlins SA, Mehra R, Morris DS, Wang L, Helgeson BE, Shah RB, Rubin MA, Wei JT, Chinnaiyan AM. Noninvasive detection of TMPRSS2:ERG fusion transcripts in the urine of men with prostate cancer. Neoplasia. 2006 Oct;8(10):885-8. doi: 10.1593/neo.06625.
- Background: PubMed 22349460Ren 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.
- Background: PubMed 23104005Gudmundsson 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.
- Background: PubMed 22386240Wang G, Chan ES, Kwan BC, Li PK, Yip SK, Szeto CC, Ng CF. Expression of microRNAs in the urine of patients with bladder cancer. Clin Genitourin Cancer. 2012 Jun;10(2):106-13. doi: 10.1016/j.clgc.2012.01.001. Epub 2012 Mar 3.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chi Fai Ng, MD principal investigator
Chinese University of Hong Kong
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Prostate Cancer, run by Chinese University of Hong Kong at 1 site in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To compare the differences in microRNA expression between non-prostate cancer subjects, pathologically insignificant and significant prostate cancer patients. (time frame: Baseline, one-time point). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03911999, which also lists 18 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Oct 2026.