Prostate Cancer Clinical Trial
Official title:
A Comprehensive Assessment of the Physical and Biological Effects of Patients With Prostate Cancer in Hong Kong
NCT number | NCT03344835 |
Other study ID # | HK-CaP |
Secondary ID | |
Status | Recruiting |
Phase | |
First received | |
Last updated | |
Start date | January 1, 2016 |
Est. completion date | December 31, 2040 |
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.
Status | Recruiting |
Enrollment | 15000 |
Est. completion date | December 31, 2040 |
Est. primary completion date | December 31, 2035 |
Accepts healthy volunteers | No |
Gender | Male |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Patient at the age of 18 or above - Patients with clinical diagnosis of prostate cancer Exclusion Criteria: - Patients diagnosed to have ductal type of prostate cancer |
Country | Name | City | State |
---|---|---|---|
Hong Kong | Prince of Wales Hospital | Shatin |
Lead Sponsor | Collaborator |
---|---|
Chinese University of Hong Kong |
Hong Kong,
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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. — View Citation
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Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Specific survival | The cancer specific survival of different disease stages in Hong Kong Chinese prostate cancer patients | 10 years | |
Secondary | Overall survival | Overall Survival of different disease stages in Hong Kong Chinese prostate cancer patients | 10 years | |
Secondary | Biological progress | Time to biochemical progression of different disease stages in Hong Kong Chinese prostate cancer patients | 10 years | |
Secondary | PSA response | PSA response for different treatment modalities at different disease stages | 10 years | |
Secondary | Complications rate | Complications rate of different modalities of treatment | 10 years |
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