Effect of ADT in Chinese Male With Prostate Cancer
Condition: Prostate Cancer
MeSH terms: Prostatic Neoplasms
Study type: Observational

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.
    

Detailed 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.
    

Intervention name(s): It is an observational study.
Intervention type(s): Other
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        60 patients diagnosed with PCa will be recruited for the study
      
Biospecimen description: 
      Blood for fasting lipid, sugar, hsCRP and other hormones (about 15cc) will be assessed in
      each study visit.
    
Keywords: Androgen deprivation therapy; Prostate cancer