Clinical trial · Observational
Real-life Evaluation of the Effect of ADT in Prostate Cancer Patients in Asia (READT Asia Study)
Prospective Study of the Effect of Androgen Deprivation Therapy (ADT) in Male Patients Suffered Prostate Cancer in Asian Population
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Androgen deprivation therapy - bilateral orchidectomy | Procedure | — | UNRESOLVED |
| Androgen deprivation therapy - GnRH agonist | Drug | — | UNRESOLVED |
| Androgen deprivation therapy - GnRH antagonist | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- label
- bilateral orchidectomy
- description
- Patients with advanced prostate cancer who receive surgical androgen deprivation therapy - bilateral orchidectomy
- interventionNames
- Procedure: Androgen deprivation therapy - bilateral orchidectomy
- label
- GnRH agonist
- description
- Patients with advanced prostate cancer who receive medical androgen deprivation therapy - GnRH agonist
- interventionNames
- Drug: Androgen deprivation therapy - GnRH agonist
- label
- GnRH antagonist
- description
- Patients with advanced prostate cancer who receive medical androgen deprivation therapy - GnRH antagonist
- interventionNames
- Drug: Androgen deprivation therapy - GnRH antagonist
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (13)
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- BACKGROUNDFang LC, Merrick GS, Wallner KE. Androgen deprivation therapy: a survival benefit or detriment in men with high-risk prostate cancer? Oncology (Williston Park). 2010 Aug;24(9):790-6, 798. PMID 20923031
- BACKGROUNDLattouf JB, Saad F. Bone complications of androgen deprivation therapy: screening, prevention, and treatment. Curr Opin Urol. 2010 May;20(3):247-52. doi: 10.1097/MOU.0b013e32833835be. PMID 20224416
- BACKGROUNDLevine GN, D'Amico AV, Berger P, Clark PE, Eckel RH, Keating NL, Milani RV, Sagalowsky AI, Smith MR, Zakai N; American Heart Association Council on Clinical Cardiology and Council on Epidemiology and Prevention, the American Cancer Society, and the American Urological Association. Androgen-deprivation therapy in prostate cancer and cardiovascular risk: a science advisory from the American Heart Association, American Cancer Society, and American Urological Association: endorsed by the American Society for Radiation Oncology. Circulation. 2010 Feb 16;121(6):833-40. doi: 10.1161/CIRCULATIONAHA.109.192695. Epub 2010 Feb 1. No abstract available. PMID 20124128
- BACKGROUNDNamiki M, Ueno S, Kitagawa Y, Fukagai T, Akaza H. Effectiveness and adverse effects of hormonal therapy for prostate cancer: Japanese experience and perspective. Asian J Androl. 2012 May;14(3):451-7. doi: 10.1038/aja.2011.121. Epub 2012 Mar 26. PMID 22447200
- BACKGROUNDRampp T, Tan L, Zhang L, Sun ZJ, Klose P, Musial F, Dobos GJ. Menopause in German and Chinese women--an analysis of symptoms, TCM-diagnosis and hormone status. Chin J Integr Med. 2008 Sep;14(3):194-6. doi: 10.1007/s11655-008-0194-1. Epub 2008 Oct 14. PMID 18853115
- Saylor PJ, Smith MR. Metabolic complications of androgen deprivation therapy for prostate cancer. J Urol. 2009 May;181(5):1998-2006; discussion 2007-8. doi: 10.1016/j.juro.2009.01.047. Epub 2009 Mar 14.