NCT03344835

Brief 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. 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15,000

participants targeted

Target at P75+ for all trials

Timeline
177mo left

Started Jan 2016

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress42%
Jan 2016Dec 2040

Study Start

First participant enrolled

January 1, 2016

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

November 14, 2017

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 17, 2017

Completed
18.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2035

Expected
5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2040

Last Updated

May 6, 2025

Status Verified

May 1, 2025

Enrollment Period

20 years

First QC Date

November 14, 2017

Last Update Submit

May 4, 2025

Conditions

Keywords

Prostate CancerDisease Outcome

Outcome Measures

Primary Outcomes (1)

  • Specific survival

    The cancer specific survival of different disease stages in Hong Kong Chinese prostate cancer patients

    10 years

Secondary Outcomes (4)

  • Overall survival

    10 years

  • Biological progress

    10 years

  • PSA response

    10 years

  • Complications rate

    10 years

Study Arms (1)

Prostate Cancer

Patients diagnosed with prostate cancer

Other: No intervention

Interventions

Prostate Cancer

Eligibility Criteria

Age18 Years+
Sexmale(Gender-based eligibility)
Gender Eligibility DetailsProstate cancer only happens in male patients
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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.

You may qualify if:

  • Patient at the age of 18 or above
  • Patients with clinical diagnosis of prostate cancer

You may not qualify if:

  • Patients diagnosed to have ductal type of prostate cancer

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Prince of Wales Hospital

Shatin, Hong Kong

RECRUITING

Related Publications (9)

  • 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.

    PMID: 22292628BACKGROUND
  • Ng 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: 24136184BACKGROUND
  • Sasagawa I, Nakada T. Epidemiology of prostatic cancer in East Asia. Arch Androl. 2001 Nov-Dec;47(3):195-201. doi: 10.1080/014850101753145906.

    PMID: 11695843BACKGROUND
  • Ng 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.

    PMID: 23223645BACKGROUND
  • Sim 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.

    PMID: 15808953BACKGROUND
  • Wang 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.

    PMID: 18667685BACKGROUND
  • Wilt 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.

    PMID: 17124221BACKGROUND
  • Wilt 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.

    PMID: 18252677BACKGROUND
  • Yip 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.

    PMID: 22192108BACKGROUND

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital Diseases

Study Officials

  • Chi Fai NG, MD

    Chinese University of Hong Kong

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
OTHER
Target Duration
10 Years
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor NG, Chi Fai

Study Record Dates

First Submitted

November 14, 2017

First Posted

November 17, 2017

Study Start

January 1, 2016

Primary Completion (Estimated)

December 31, 2035

Study Completion (Estimated)

December 31, 2040

Last Updated

May 6, 2025

Record last verified: 2025-05

Data Sharing

IPD Sharing
Will not share

Locations