Clinical trial NCT04341324: Effect of ADT in Chinese Male With Prostate Cancer
Official title: Prospective Study of the Effect of Androgen Deprivation Therapy (ADT) in Male Patients Suffered Prostate Cancer in Chinese Population
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Prostate Cancer
Keywords: Androgen deprivation therapy
Prostate cancer
Lead sponsor: Chinese University of Hong Kong
Sponsor class: OTHER
First posted: 2020-04-10
Enrollment: 60
Sex: MALE
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 60 patients diagnosed with PCa will be recruited for the study

Brief 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.

Eligibility criteria: For those received hormonal therapy will be recruited for study (active arm) Study subject inclusion criteria

1. Male patients 18 years or older
2. Adenocarcinoma of the prostate either histologically or cytologically confirmed
3. Decided to be put on ADT -bilateral orchidectomy or LHRH agonist or LHRH antagonist, with or without additional antiandrogen
4. After ADT performed, serum testosterone level should reach castrated level, i.e. \< 50 ng/dL after 6 weeks of treatment
5. Able to consent for the participate in the study

For those do not plan to receive hormonal therapy (based on the clinical assessment by the investigators) will be recruited as control arm

Control subject:

1. Male patients 18 years or older
2. Adenocarcinoma of the prostate either histologically or cytologically confirmed
3. Able to consent for the participate in the study

Exclusion Criteria:

1. Patient did not able to provide consent or comply with the follow-up arrangement
2. Patient with life expectancy of less than 2 years - based on clinical judgement

Primary outcomes:
measure: Change from Baseline cardiovascular risk at 24 months
timeFrame: At baseline and month-24
Secondary outcomes:
measure: Change from Baseline total cholesterol at 24 months
timeFrame: At baseline and month-24
measure: Change from Baseline low density lipoprotein at 24 months
timeFrame: At baseline and month-24
measure: Change from Baseline high-density lipoprotein at 24 months
timeFrame: At baseline and month-24
measure: Change from Baseline triglyceride at 24 months
timeFrame: At baseline and month-24
measure: Change from Baseline body mass index (BMI) at 24 months
timeFrame: At baseline and month-24
measure: Change from Baseline body composition at 24 months
timeFrame: At baseline and month-24
measure: Change from Baseline mental state at 24 months
timeFrame: At baseline and month-24
measure: Change from Baseline vascular arterial stiffness at 24 months
timeFrame: At baseline and month-24
measure: Change from Baseline ankle brachial index (ABI) at 24 months
timeFrame: At baseline and month-24
measure: Compare cardiovascular events
timeFrame: At month-24
measure: Change from Baseline bone mineral density at 24 months
timeFrame: At baseline and month-24
measure: Compare skeletal related events
timeFrame: At month-24
Other outcomes:
Locations:
Study officials:
affiliation: Chinese University of Hong Kong
name: Chi Fai NG, MD
role: PRINCIPAL_INVESTIGATOR
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