Hong Kong Prostate Cancer Study Group Database

January 21, 2024 updated by: Chi Fai NG, Chinese University of Hong Kong

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Estimated)

15000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Prostate Cancer
Patients diagnosed with prostate cancer
Other: No intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Specific survival
Time Frame: 10 years
The cancer specific survival of different disease stages in Hong Kong Chinese prostate cancer patients
10 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall survival
Time Frame: 10 years
Overall Survival of different disease stages in Hong Kong Chinese prostate cancer patients
10 years
Biological progress
Time Frame: 10 years
Time to biochemical progression of different disease stages in Hong Kong Chinese prostate cancer patients
10 years
PSA response
Time Frame: 10 years
PSA response for different treatment modalities at different disease stages
10 years
Complications rate
Time Frame: 10 years
Complications rate of different modalities of treatment
10 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chinese University of Hong Kong

Investigators

  • Principal Investigator: Chi Fai NG, MD, Chinese University of Hong Kong

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2016

Primary Completion (Estimated)

December 31, 2035

Study Completion (Estimated)

December 31, 2040

Study Registration Dates

First Submitted

November 14, 2017

First Submitted That Met QC Criteria

November 15, 2017

First Posted (Actual)

November 17, 2017

Study Record Updates

Last Update Posted (Actual)

January 23, 2024

Last Update Submitted That Met QC Criteria

January 21, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HK-CaP

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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