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NCT Number: NCT03703778

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

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.

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Key information

Age range

18 year and older

Sex eligibility

Male

Study type

Observational

Primary location

Prince of Wales Hospital

Shatin, Hong Kong

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Androgen deprivation therapy - bilateral orchidectomy

Procedure

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.

Androgen deprivation therapy - GnRH agonist

Drug

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.

Other names: Enantone, Eligard

Androgen deprivation therapy - GnRH antagonist

Drug

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.

Other names: Degarelix

Primary outcomes

  1. 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

  1. The incidence of cardiovascular complications in prostate cancer patients receiving androgen deprivation therapy

    Time frame: 5 years

    The incidence of cardiovascular complications, such as myocardial infarction, stroke, etc, in prostate cancer patients receiving different form of androgen deprivation therapy

  2. The disease response in prostate cancer patients receiving different ADT

    Time frame: baseline, 6-month, 12 month, and then 6 monthly until 5 years

    To assess PSA progression in patients receiving different ADT

Sponsors and collaborators

Lead sponsor

Chinese University of Hong Kong

Other

Registry information

Official study title

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

Acronym: READT

Important dates

Study start
2016
Primary completion
2025
Study completion
2026
First posted
Oct 12, 2018
Registry last updated
May 6, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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