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Trial record 20 of 1543 for:    Androgens

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

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ClinicalTrials.gov Identifier: NCT03703778
Recruitment Status : Recruiting
First Posted : October 12, 2018
Last Update Posted : October 12, 2018
Sponsor:
Information provided by (Responsible Party):
Chi Fai NG, Chinese University of Hong Kong

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.


Condition or disease Intervention/treatment
Prostate Cancer Procedure: Androgen deprivation therapy - bilateral orchidectomy Drug: Androgen deprivation therapy - GnRH agonist Drug: Androgen deprivation therapy - GnRH antagonist

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.


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Study Type : Observational
Estimated Enrollment : 600 participants
Observational Model: Case-Crossover
Time Perspective: Prospective
Official Title: Prospective Study of the Effect of Androgen Deprivation Therapy (ADT) in Male Patients Suffered Prostate Cancer in Asian Population
Actual Study Start Date : May 22, 2016
Estimated Primary Completion Date : October 31, 2019
Estimated Study Completion Date : December 31, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

Group/Cohort Intervention/treatment
bilateral orchidectomy
Patients with advanced prostate cancer who receive surgical androgen deprivation therapy - bilateral orchidectomy
Procedure: Androgen deprivation therapy - bilateral orchidectomy
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.

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

GnRH antagonist
Patients with advanced prostate cancer who receive medical androgen deprivation therapy - GnRH antagonist
Drug: Androgen deprivation therapy - GnRH antagonist
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 Name: Degarelix




Primary Outcome Measures :
  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 Outcome Measures :
  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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Only male patients got prostate cancer
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients who come to our hospital urology specialist clinics and received androgen deprivative therapy will be recruited.
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03703778


Contacts
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Contact: Chi Fai NG, MD 3505 3953 ngcf@surgery.cuhk.edu.hk
Contact: Siu Ying YIP, MPH 3505 1663 siuying@surgery.cuhk.edu.hk

Locations
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Hong Kong
Prince of Wales Hospital Recruiting
Shatin, Hong Kong
Contact: Chi Fai NG, MD    3505 3953    ngcf@surgery.cuhk.edu.hk   
Contact: Siu Ying YIP, MPH    3505 1663    siuying@surgery.cuhk.edu.hk   
Sponsors and Collaborators
Chinese University of Hong Kong
Investigators
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Principal Investigator: Chi Fai NG, MD Chinese University of Hong Kong

Publications:

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Responsible Party: Chi Fai NG, Clinical Professor, Chinese University of Hong Kong
ClinicalTrials.gov Identifier: NCT03703778     History of Changes
Other Study ID Numbers: READT Asia
First Posted: October 12, 2018    Key Record Dates
Last Update Posted: October 12, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Chi Fai NG, Chinese University of Hong Kong:
Prostate Cancer
Androgen deprivation therapy
Additional relevant MeSH terms:
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Androgens
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Ascorbic Acid
Methyltestosterone
Triptorelin Pamoate
Estrogens, Conjugated (USP)
Prolactin Release-Inhibiting Factors
Deslorelin
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Vitamins
Micronutrients
Nutrients
Growth Substances
Estrogens
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Anabolic Agents
Enzyme Inhibitors
Luteolytic Agents