CI

At a glance

ClinicalIndex Comparison Record
N/AActive· 300 enrolled
Drug / intervention
Androgen deprivation therapy - GnRH agonist +2 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03703778
NCT03703778N/AActive

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

Chinese University of Hong Kong·observational·Posted Oct 12, 2018·Updated May 6, 2025

In Brief

An observational study evaluating Androgen deprivation therapy - bilateral orchidectomy, Androgen deprivation therapy - GnRH agonist, and 1 other intervention for Prostate Cancer. Active but no longer recruiting, targeting 300 participants across 1 site.

Detailed 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.

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
ConditionsProstate Cancer
CountriesHong Kong
Collaborators--

Timeline

N/AActiveOverdue
2017201820192020202120222023202420252026
First PostedOct 12, 2018
Enrollment StartMay 22, 2016
Primary CompletionDec 31, 2025
Study CompletionMar 31, 2026
TodayJul 1, 2026
Enrollment to primary: 9.6 yearsPosted 7.7 years ago

Interventions

Androgen deprivation therapy - bilateral orchidectomyprocedure

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 agonistdrug

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 antagonistdrug

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.