Prostate CancerNCT03344835
Hong Kong Prostate Cancer Study Group Database
An observational study of Prostate Cancer, run by Chinese University of Hong Kong at 1 site in Hong Kong.
Trial summary
Prostate cancer (PCa) is ranked 3rd in annual incidence of male cancer and ranked 5th for cancer-related death in men in Hong Kong which accounts for about 9.1 deaths per 100,000 men in 2011. Its incidence is rising rapidly, almost tripled in the past 10 years. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer
- How many people
- 15,000 participants
- Where
- 1 siteHong Kong
- Study dates
- 1 Jan 2016to 31 Dec 2040
- How long will I take part?
- 10 Years
- Phase
- Observational
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 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Study population: All patients diagnosed with prostate cancer, in NDH, PWH and TMH, since 1995 would be included in the registry. Both retrospective and prospective cohort study design will be adopted in this study. Patients diagnosed with prostate cancer in the hospitals under the NTEC \& NTWC cluster will be identified in specialist clinics, wards, and during TRUS, and then enrolled to the study.
Who may be able to join
- Patient at the age of 18 or above
- Patients with clinical diagnosis of prostate cancer
Who cannot join
- Patients diagnosed to have ductal type of prostate cancer
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Hong Kong1 site, 1 recruiting
- Recruiting
Prince of Wales Hospital
Shatin
Chi Fai NG, MD, 3505 3953, ngcf@surgery.cuhk.edu.hk
Siu Ying YIP, MPH, 3505 1663, siuying@surgery.cuhk.edu.hk
About this study
Official title: A Comprehensive Assessment of the Physical and Biological Effects of Patients With Prostate Cancer in Hong Kong
Prostate cancer (PCa) is ranked 3rd in annual incidence of male cancer and ranked 5th for cancer-related death in men in Hong Kong which accounts for about 9.1 deaths per 100,000 men in 2011. Its incidence is rising rapidly, almost tripled in the past 10 years. In Hong Kong, the two main screening methods for PCa are digital rectal examination (DRE) and serum prostate-specific antigen (PSA) level blood test, and the gold standard of diagnosis of PCa is transrectal ultrasound (TRUS) with prostate biopsy.
For those who diagnosed with PCa, there are different kinds of managements depending on patient's age group and disease stage. Watchful waiting is for older patients who presents with low-risk prostate cancer. And active surveillance is applicable to patients who are eligible for potentially curative management. While radiotherapy or radical prostatectomy are recommended as curative management for early stage PCa, androgen deprivation therapy (ADT) is the main treatment modality for advanced or recurrent prostate cancer. Advanced prostate cancer that recurrence is called castration refractory prostate cancer (CRPC). There are many new agents, including second line hormonal therapy, chemotherapy, androgen biosynthesis inhibitors, immunotherapy, bone targeting agents etc., available for the further management.
In this study, investigators would like to establish a local prostate cancer registry to facilitate the collection of clinical information and outcomes of prostate cancer management. Hopefully, this registry can provide information regarding the epidemiology, natural history, and treatment outcomes of local prostate cancer. The information would be helpful for research, public education, health care planning and also international collaboration. Ultimately, patients and public would be benefited from these works.
Read the detailed description
The prostate gland is a clinically important male accessory sex gland and vital for its production of semen. Prostate cancer (PCa) is ranked 3rd in annual incidence of male cancer and ranked 5th for cancer-related death in men in Hong Kong which accounts for about 9.1 deaths per 100,000 men in 2011. Its incidence is rising rapidly, almost tripled in the past 10 years. Although this cancer is extremely rare before age 40 but the incidence increases with age, as the elderly population continues to increase, the impact of PCa on the men's health and also the burden on health care system will continue to rise. In addition to age, epidemiological data shows that race is also an important risk factor for prostate cancer. African-American men have the highest rates of prostate cancer in the world. For Asian populations, native Chinese and Japanese showed the lowest prostate cancer rates, though the incidence is rapidly increasing in the past decades.
The two main screening methods for PCa are digital rectal examination (DRE) and serum prostate-specific antigen (PSA) level blood test. DRE is an exam to check for growths or enlargement of the prostate gland. A tumor in the prostate can often be felt as a hard nodule. This may be done as a regular exam or check for the symptoms. If problems are suspected, DRE is usually done together with PSA, which was first introduced to evaluate the possibility of present of PCa in 1987. A common PSA threshold for biopsy in Hong Kong and Asia is PSA level greater than 4.0 ng/mL. Despite the controversial of PSA and some newer markers for PSA diagnosis, it is still the most common screening for PCa, due to the low cost and simplicity.
The gold standard of diagnosis of PCa is transrectal ultrasound (TRUS) with prostate biopsy. During the procedure, usually ten cores of biopsies will be taken and sent for pathological evaluation. If any of the biopsies are found malignant, Gleason score will be given and the stage of cancer will be determined.
Unlike other malignancy, PCa is characterized by its slow progression nature and even for metastatic disease the 5-year survival is up to 20%. Therefore, there will be different kinds of management for difference age group and disease stage: active surveillance (AS), watchful waiting, and treatments. Watchful waiting is for older patients who presents with low-risk prostate cancer. In these cases, treatment is probably not suitable for them due to the old age and low effectiveness. Contrasting watchful waiting, AS is applicable to patients who are eligible for potentially curative management. During AS, PCa is closely monitored for signs of progression. PSA blood test and DRE are usually administered at times along with a repeat biopsy of the prostate at one year and then at specific intervals thereafter. If symptoms develop, or if tests indicate the cancer is growing, treatment will be necessary.
For early stage of prostate cancer, radiotherapy or radical prostatectomy are recommended as curative management. The purpose of these treatments is to cure the disease. Over 80% of patients were cured with no recurrence. Currently, robotic prostatectomy is the main surgical approach for localized prostate cancer with acceptable perioperative results. Radiotherapy, both external beam and brachytherapy, are also standard therapy for prostate cancer. The overall complication rate, as reported from the Western literatures, for both surgery and radiotherapy are quite low. The final choice of treatment will largely depend on the join decision between physicians and patients.
However, for advanced or recurrent prostate cancer, androgen deprivation therapy (ADT) is the main treatment modality. While the effectiveness of ADT is well documented in the literature, the adverse effect profile in Asian patients, in particular to the cardiovascular system and bone metabolism, was not well documented.
Due to the continue changes in the behavior of prostate cancer cell under androgen deprivated environment, advanced prostate cancer will eventually entered a stage of castration refractory prostate cancer (CRPC). Currently, there are many new agents, including second line hormonal therapy, chemotherapy, androgen biosynthesis inhibitors, immunotherapy, bone targeting agents etc., available for the further management of these CRPC patients. Unfortunately, the clinical outcome and side effect profiles for further treatment for patients with in local Chinese population, as well as in Asian population was still not that certain.
Due to the continue changes in the behavior of prostate cancer cell under androgen deprived environment, advanced prostate cancer will eventually entered a stage of castration refractory prostate cancer (CRPC). Currently, there are many new agents, including second line hormonal therapy, chemotherapy, androgen biosynthesis inhibitors, immunotherapy, bone targeting agents etc., available for the further management of these CRPC patients. Unfortunately, the clinical outcome and side effect profiles for further treatment for patients with in local Chinese population, as well as in Asian population was still not that certain.
Facing the increase in clinical demand by the drastic increase in patient population, together with the rapid development in various therapies for different stages of prostate cancer, there is a need to have better understanding about the natural history, clinical outcomes of various therapies for prostate cancer. Therefore, investigators would like to establish a local prostate cancer registry to facilitate the collection of clinical information and outcomes of prostate cancer management. Hopefully, this registry can provide information regarding the epidemiology, natural history, and treatment outcomes of local prostate cancer. The information would be helpful for research, public education, health care planning and also international collaboration. Ultimately, patients and public would be benefited from these works
In this study, both retrospective and prospective cohort study design will be adopted. Patients diagnosed with prostate cancer from 2016 will be captured prospectively and those who diagnosed in or before 2015 will be captured retrospectively. Patients diagnosed with prostate cancer in the hospitals under the New Territories East Cluster (NTEC) \& New Territories West Cluster (NTWC) will be identified in specialist clinics, wards, and during TRUS, and then enrolled to the study. This study will be conducted by observation; no intervention article is used. The time of diagnosis of prostate cancer will be set as baseline of that subject. All the demographic and medical background will be traced back. All patients will be followed up every 6 months and thereafter. During the follow-up, patients' medical status including survival, cancer status, treatment, complications will be captured from the medical records.
- Conditions
- Prostate Cancer
- Being tested
- No intervention
- Keywords
- Prostate Cancer, Disease Outcome
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
| Study group | Role | What they receive |
|---|---|---|
| Prostate Cancer | Patients diagnosed with prostate cancer Receives: Other: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Specific survival
The cancer specific survival of different disease stages in Hong Kong Chinese prostate cancer patients
Measured: 10 years
Secondary outcomes (4)
Overall survival
Overall Survival of different disease stages in Hong Kong Chinese prostate cancer patients
Measured: 10 years
Biological progress
Time to biochemical progression of different disease stages in Hong Kong Chinese prostate cancer patients
Measured: 10 years
PSA response
PSA response for different treatment modalities at different disease stages
Measured: 10 years
Complications rate
Complications rate of different modalities of treatment
Measured: 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2017
- Study start1 Jan 2016
- Primary completion31 Dec 2035 (estimated)
- Study completion31 Dec 2040 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)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
- Other
- Enrolment
- 15,000 participants (estimated)
- Target duration
- 10 Years
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
- NCT03344835
- Sponsor's protocol ID
- HK-CaP
- Status last verified
- Oct 2026
- First submitted
- 14 Nov 2017
- Last updated
- 22 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Chiu PK, Wong AY, Hou SM, Yip SK, Ng CF. Effect of body mass index on serum prostate-specific antigen levels among patients presenting with lower urinary tract symptoms. Asian Pac J Cancer Prev. 2011;12(8):1937-40.
PubMed 22292628Ng 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.
PubMed 24136184Sasagawa I, Nakada T. Epidemiology of prostatic cancer in East Asia. Arch Androl. 2001 Nov-Dec;47(3):195-201. doi: 10.1080/014850101753145906.
PubMed 11695843Ng 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 23223645Sim HG, Cheng CW. Changing demography of prostate cancer in Asia. Eur J Cancer. 2005 Apr;41(6):834-45. doi: 10.1016/j.ejca.2004.12.033.
PubMed 15808953Wang W, Yuasa T, Tsuchiya N, Maita S, Kumazawa T, Inoue T, Saito M, Ma Z, Obara T, Tsuruta H, Satoh S, Habuchi T. Bone mineral density in Japanese prostate cancer patients under androgen-deprivation therapy. Endocr Relat Cancer. 2008 Dec;15(4):943-52. doi: 10.1677/ERC-08-0116. Epub 2008 Jul 30.
PubMed 18667685Wilt TJ, Thompson IM. Clinically localised prostate cancer. BMJ. 2006 Nov 25;333(7578):1102-6. doi: 10.1136/bmj.39022.423588.DE. No abstract available.
PubMed 17124221Wilt TJ, MacDonald R, Rutks I, Shamliyan TA, Taylor BC, Kane RL. Systematic review: comparative effectiveness and harms of treatments for clinically localized prostate cancer. Ann Intern Med. 2008 Mar 18;148(6):435-48. doi: 10.7326/0003-4819-148-6-200803180-00209. Epub 2008 Feb 4.
PubMed 18252677Yip KH, Yee CH, Ng CF, Lam NY, Ho KL, Ma WK, Li CM, Hou SM, Tam PC, Yiu MK, Fan CW. Robot-assisted radical prostatectomy in Hong Kong: a review of 235 cases. J Endourol. 2012 Mar;26(3):258-63. doi: 10.1089/end.2011.0303. Epub 2012 Jan 4.
PubMed 22192108Ko ICH, Mok CHT, Leung DKW, Wong CHM, Chow JHC, Mok A, Liu AQ, Siu BWH, Yuen SKK, Yee CH, Chiu PKF, Teoh JYC, Wong K, Ng CF. Incidence and predictors of radiation proctitis or radiation cystitis after radiotherapy in patients with prostate cancer. Hong Kong Med J. 2026 Jun;32(3):225-233. doi: 10.12809/hkmj2412691. Epub 2026 Jun 17.
PubMed 42305065