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

NCT03703778 | Active Not Recruiting

• 1 other identifier: READT Asia
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

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.

Conditions

Prostate Cancer

Keywords

Prostate Cancer; Androgen deprivation therapy

Outcome Measures

Primary Outcomes (1)

• The proportion of patients using surgical castration and medical castration in prostate cancer patients in Asia

  The proportion of patients using surgical castration and medical castration in prostate cancer patients in Asia

  5 years

Secondary Outcomes (2)

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

  5 years

• The disease response in prostate cancer patients receiving different ADT

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

Study Arms (3)

bilateral orchidectomy

Patients with advanced prostate cancer who receive surgical androgen deprivation therapy - bilateral orchidectomy

Procedure: Androgen deprivation therapy - bilateral orchidectomy

GnRH agonist

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

Drug: Androgen deprivation therapy - GnRH agonist

GnRH antagonist

Patients with advanced prostate cancer who receive medical androgen deprivation therapy - GnRH antagonist

Drug: Androgen deprivation therapy - GnRH antagonist

Interventions

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.

bilateral orchidectomy

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.

Also known as: Enantone, Eligard

GnRH agonist

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.

Also known as: Degarelix

GnRH antagonist

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Only male patients got prostate cancer
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients who come to our hospital urology specialist clinics and received androgen deprivative therapy will be recruited.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Chinese University of Hong Kong: lead

Study Sites (1)

Prince of Wales Hospital

Shatin, Hong Kong

Location

Related Publications (13)

• Beauchet O. Testosterone and cognitive function: current clinical evidence of a relationship. Eur J Endocrinol. 2006 Dec;155(6):773-81. doi: 10.1530/eje.1.02306.

  PMID: 17132744 BACKGROUND

• Fang 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 BACKGROUND

• Lattouf 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 BACKGROUND

• Levine 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 BACKGROUND

• Namiki 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 BACKGROUND

• Rampp 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 BACKGROUND

• 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.

  PMID: 19286225 BACKGROUND

• Smith MR. Treatment-related diabetes and cardiovascular disease in prostate cancer survivors. Ann Oncol. 2008 Sep;19 Suppl 7(Suppl 7):vii86-90. doi: 10.1093/annonc/mdn458. No abstract available.

  PMID: 18790986 BACKGROUND

• Taylor LG, Canfield SE, Du XL. Review of major adverse effects of androgen-deprivation therapy in men with prostate cancer. Cancer. 2009 Jun 1;115(11):2388-99. doi: 10.1002/cncr.24283.

  PMID: 19399748 BACKGROUND

• Teoh JY, Chiu PK, Chan SY, Poon DM, Cheung HY, Hou SS, Ng CF. Risk of ischemic stroke after androgen deprivation therapy for prostate cancer in the Chinese population living in Hong Kong. Jpn J Clin Oncol. 2015 May;45(5):483-7. doi: 10.1093/jjco/hyv025. Epub 2015 Feb 26.

  PMID: 25724216 BACKGROUND

• Teoh JY, Chan SY, Chiu PK, Poon DM, Cheung HY, Hou SS, Ng CF. Risk of cardiovascular thrombotic events after surgical castration versus gonadotropin-releasing hormone agonists in Chinese men with prostate cancer. Asian J Androl. 2015 May-Jun;17(3):493-6. doi: 10.4103/1008-682X.143313.

  PMID: 25578930 BACKGROUND

• Teoh JY, Chan SY, Chiu PK, Poon DM, Cheung HY, Hou SS, Ng CF. Risk of acute myocardial infarction after androgen-deprivation therapy for prostate cancer in a Chinese population. BJU Int. 2015 Sep;116(3):382-7. doi: 10.1111/bju.12967. Epub 2015 Mar 7.

  PMID: 25327618 BACKGROUND

• Teoh JY, Chiu PK, Chan SY, Poon DM, Cheung HY, Hou SS, Ng CF. Risk of new-onset diabetes after androgen deprivation therapy for prostate cancer in the Asian population. J Diabetes. 2015 Sep;7(5):672-80. doi: 10.1111/1753-0407.12226. Epub 2014 Dec 22.

  PMID: 25266491 BACKGROUND

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Leuprolide; luprolide acetate gel depot; acetyl-2-naphthylalanyl-3-chlorophenylalanyl-1-oxohexadecyl-seryl-4-aminophenylalanyl(hydroorotyl)-4-aminophenylalanyl(carbamoyl)-leucyl-ILys-prolyl-alaninamide

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Gonadotropin-Releasing Hormone; Pituitary Hormone-Releasing Hormones; Hypothalamic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Neuropeptides; Peptides; Amino Acids, Peptides, and Proteins; Oligopeptides; Nerve Tissue Proteins; Proteins

Study Officials

• Chi Fai NG, MD

  Chinese University of Hong Kong

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CROSSOVER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: March 12, 2018
• First Posted: October 12, 2018
• Study Start: May 22, 2016
• Primary Completion: December 31, 2025
• Study Completion: March 31, 2026
• Last Updated: May 6, 2025

Record last verified: 2025-05

Locations

HK (1)