Effect of ADT in Chinese Male With Prostate Cancer

Prostate Cancer Clinical Trial

Official title: Prospective Study of the Effect of Androgen Deprivation Therapy (ADT) in Male Patients Suffered Prostate Cancer in Chinese Population

Status Completed

Clinical Trial Summary

Many prostate cancer patients required the use of androgen deprivation therapy (ADT) for the control of disease.

In this study, the investigators aim at assessing the different in various parameters between PCa patients received ADT and those without ADT.

60 patients diagnosed with PCa and planned for hormonal therapy will be recruited for study (active arm) and 30 PCa patients that do not planned to receive hormonal therapy (based on the clinical assessment by the investigators) will be recruited as control arm.

After written consent obtained from study subject, a series of investigation will be arranged to assess the following aspect of the subjects before the commenced of ADT:

• General condition - symptoms, general health,

• Body composition - BMI and body composition

• Mental state assessment by Mini-Mental State Examination (MMSE)

• Blood for fasting lipid, sugar, hsCRP and other hormones (about 15cc)

• Cardiovascular status - BP, Ankle-brachial index (ABI), Arterial stiffness, ECG,

• Bone status - bone mineral density by dual-energy X-ray absorptiometry (DEXA) scan

The assessment of general condition, body composition, blood parameter and cardiovascular status will be performed every 26weeks +/- 1 weeks for two years. Bone density measurement will be performed every 52 weeks +/- 2 weeks.

Appropriate medical referral will be made if subject was found to have abnormal metabolic or cardiovascular parameters.

Clinical Trial 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 4th in annual incidence of male cancer and ranked 8th for cancer-related death in men in Hong Kong which accounts for about 6.2 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.

Traditionally, in order to achieve a complete control of PCa, ADT is given in a continue manner, either in the form of bilateral orchidectomy or regular luteinizing hormone releasing hormone injection. However, in order to balance the benefit and potential of long-term complication, intermittent hormonal therapy (IHT) become increasing common to be used in patients suffered PCa, in particular those with low tumour volume and low-grade disease. However, formal comparison of the benefit, in term of side effect reduction, for IHT compare to traditional continue-hormonal suppression is still lacking.

Unfortunately information regarding the side effects of ADT in Chinese population is lacking. However, there are some evidences from female menopause related studies that there may be some differences in the presentation and prevalence of sex hormone deprivation in difference racial groups. Therefore, there is a need to have more information on the adverse effect profiles related to ADT (both complete and IHT) in Chinese population. ;

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

• NCT number: NCT04341324
• Study type: Observational
• Source: Chinese University of Hong Kong
• Status: Completed
• Start date: July 14, 2011
• Completion date: December 4, 2019