Real-life Evaluation of the Effect of ADT in Prostate Cancer Patients in Asia (READT Asia Study)

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Prostate Cancer

Intervention / Treatment
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* Procedure: Androgen deprivation therapy - bilateral orchidectomy
* Drug: Androgen deprivation therapy - GnRH agonist
* Drug: Androgen deprivation therapy - GnRH antagonist


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| bilateral orchidectomy<br>Patients with advanced prostate cancer who receive surgical androgen deprivation therapy - bilateral orchidectomy | Procedure: Androgen deprivation therapy - bilateral orchidectomy<br>* Androgen deprivation therapy (ADT) is a kind of hormone therapy for prostate cancer. The goal is to reduce levels of male hormones, called androgens, in the body, or to stop them from affecting prostate cancer cells. It can be surgical, i.e. bilateral orchidectomy, or medical, i.e. GnRH agonist or GnRH antagonist.<br>|
| GnRH agonist<br>Patients with advanced prostate cancer who receive medical androgen deprivation therapy - GnRH agonist | Drug: Androgen deprivation therapy - GnRH agonist<br>* Androgen deprivation therapy (ADT) is a kind of hormone therapy for prostate cancer. The goal is to reduce levels of male hormones, called androgens, in the body, or to stop them from affecting prostate cancer cells. It can be surgical, i.e. bilateral orchidectomy, or medical, i.e. GnRH agonist or GnRH antagonist.<br>* Other names: Eligard;|
| GnRH antagonist<br>Patients with advanced prostate cancer who receive medical androgen deprivation therapy - GnRH antagonist | Drug: Androgen deprivation therapy - GnRH antagonist<br>* Androgen deprivation therapy (ADT) is a kind of hormone therapy for prostate cancer. The goal is to reduce levels of male hormones, called androgens, in the body, or to stop them from affecting prostate cancer cells. It can be surgical, i.e. bilateral orchidectomy, or medical, i.e. GnRH agonist or GnRH antagonist.<br>* Other names: Degarelix;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The proportion of patients using surgical castration and medical castration in prostate cancer patients in Asia | The proportion of patients using surgical castration and medical castration in prostate cancer patients in Asia | 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The incidence of cardiovascular complications in prostate cancer patients receiving androgen deprivation therapy | The incidence of cardiovascular complications, such as myocardial infarction, stroke, etc, in prostate cancer patients receiving different form of androgen deprivation therapy | 5 years | 
| The disease response in prostate cancer patients receiving different ADT | To assess PSA progression in patients receiving different ADT | baseline, 6-month, 12 month, and then 6 monthly until 5 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Prostate Cancer, Androgen deprivation therapy