Clinical trial
Prospective Study of the Effect of Androgen Deprivation Therapy (ADT) in Male Patients Suffered Prostate Cancer in Asian Population
Name
READT Asia
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. 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.
Trial arms
Trial start
2016-05-22
Estimated PCD
2025-10-31
Trial end
2025-12-31
Status
Active (not recruiting)
Treatment
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.
Arms:
bilateral orchidectomy
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.
Arms:
GnRH agonist
Other names:
Enantone, Eligard
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.
Arms:
GnRH antagonist
Other names:
Degarelix
Size
300
Primary endpoint
The proportion of patients using surgical castration and medical castration in prostate cancer patients in Asia
5 years
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
Protocol
{'studyType': 'OBSERVATIONAL', 'patientRegistry': False, 'designInfo': {'observationalModel': 'CASE_CROSSOVER', 'timePerspective': 'PROSPECTIVE'}, 'enrollmentInfo': {'count': 300, 'type': 'ACTUAL'}}
Updated at
2024-01-23
1 organization
2 products
1 indication
Organization
Chinese University of Hong KongIndication
Prostate Cancer