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Clinical Trials/NCT03703778
NCT03703778
Active, not recruiting
Not Applicable

Prospective Study of the Effect of Androgen Deprivation Therapy (ADT) in Male Patients Suffered Prostate Cancer in Asian Population

Chinese University of Hong Kong1 site in 1 country300 target enrollmentMay 22, 2016

Overview

Phase
Not Applicable
Intervention
Androgen deprivation therapy - bilateral orchidectomy
Conditions
Prostate Cancer
Sponsor
Chinese University of Hong Kong
Enrollment
300
Locations
1
Primary Endpoint
The proportion of patients using surgical castration and medical castration in prostate cancer patients in Asia
Status
Active, not recruiting
Last Updated
12 months ago

Overview

Brief 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. Its incidence is rising rapidly, almost tripled in the past 10 years. Despite the improvement in awareness of the disease and also increasing use of serum prostate specific antigen, many patients still presented at a late stage that beyond cure by local therapy. Together with those patients suffered recurrent disease after local therapy, many PCa patients required the use of androgen deprivation therapy (ADT) for the control of disease.

However, unlike other malignancy, PCa is characterized by its slow progression nature and even for metastatic disease the 5-year survival is upto 20%. Therefore, while ADT can provide effective control of disease, there are increasing evidences suggesting that it can also result in many adverse effects in the patients, and these effects are particular important due to the long survival of these patients. From the western literature, the adverse effects can be quite diverse. Classical side effects after ADT include mood changes, hot flushes, change in cognitive function, loss of libido, erectile dysfunction, osteoporosis and pathological fracture, insulin resistance and increase in risk of cardiovascular related mortality.

Unfortunately information regarding the side effects of ADT in Asian population is scanty and inconclusive. Therefore, there is a need to have more information on the adverse effect profiles related to ADT in Asian population.

This is a multicentre, prospective, observational, non-interventional study to assess the clinical effectiveness, cardiometabolic and skeletal effects of the various type of ADT - bilateral orchidectomy, GnRH agonist, and GnRH antagonist - in men with advanced prostate cancer over a minimum of 1-year observation period.

Detailed Description

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. 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. Despite the improvement in awareness of the disease and also increasing use of serum prostate specific antigen, many patients still presented at a late stage that beyond cure by local therapy. Together with those patients suffered recurrent disease after local therapy, many PCa patients required the use of androgen deprivation therapy (ADT) for the control of disease. However, unlike other malignancy, PCa is characterized by its slow progression nature and even for metastatic disease the 5-year survival is upto 20%. Therefore, while ADT can provide effective control of disease, there are increasing evidences suggesting that it can also result in many adverse effects in the patients, and these effects are particular important due to the long survival of these patients. From the western literature, the adverse effects can be quite diverse. Classical side effects after ADT include mood changes, hot flushes, change in cognitive function, loss of libido, erectile dysfunction, osteoporosis and pathological fracture. Also there are more and more evidences showed ADT will also altered the metabolic and cardiovascular status of the patients and resulted in increase in insulin resistance and increase in risk of cardiovascular related mortality. However, there is a lack of data concerning the association between ADT and various complications in the Asian population. Due to the genetic and physiological differences and the experience from studies on female menopause the cardiovascular risk profile may differ between different ethnicities. Reports from Japan suggested the effects of ADT in Japanese were different from Caucasian with better treatment efficacy and lower cardiovascular risk. However, reports from Hong Kong suggested the adverse effects of ADT in Chinese populations were quite similar to the reports in Western world. Moreover, due to the difference in social and cultural background in Asian countries, the usage of different modalities of ADT might be different in different areas, which might also affect the efficacy and outcomes in patients. Therefore, investigator would like to perform a prospective study on the practice and effect of ADT in Asian population to try to clarify the effect of ADT in our regional population.

Registry
clinicaltrials.gov
Start Date
May 22, 2016
End Date
March 31, 2026
Last Updated
12 months ago
Study Type
Observational
Sex
Male

Investigators

Responsible Party
Principal Investigator
Principal Investigator

NG Chi Fai

Clinical Professor

Chinese University of Hong Kong

Eligibility Criteria

Inclusion Criteria

  • All new, consecutive patients with histological proven prostate cancer or clinically diagnosed to have prostate cancer, who decided for ADT would be recruited for the study

Exclusion Criteria

  • Prior neoadjuvant or adjuvant hormone therapy within 1 year before
  • Refuse or unable to give written informed consent
  • Participation in an investigational program with interventions outside of routine clinical practice

Arms & Interventions

bilateral orchidectomy

Patients with advanced prostate cancer who receive surgical androgen deprivation therapy - bilateral orchidectomy

Intervention: Androgen deprivation therapy - bilateral orchidectomy

GnRH agonist

Patients with advanced prostate cancer who receive medical androgen deprivation therapy - GnRH agonist

Intervention: Androgen deprivation therapy - GnRH agonist

GnRH antagonist

Patients with advanced prostate cancer who receive medical androgen deprivation therapy - GnRH antagonist

Intervention: Androgen deprivation therapy - GnRH antagonist

Outcomes

Primary Outcomes

The proportion of patients using surgical castration and medical castration in prostate cancer patients in Asia

Time Frame: 5 years

The proportion of patients using surgical castration and medical castration in prostate cancer patients in Asia

Secondary Outcomes

  • The incidence of cardiovascular complications in prostate cancer patients receiving androgen deprivation therapy(5 years)
  • The disease response in prostate cancer patients receiving different ADT(baseline, 6-month, 12 month, and then 6 monthly until 5 years)

Study Sites (1)

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