Clinical trial NCT04687709: To Investigate the Role of Gut Microbiome in ADT Related Metabolic Changes in Prostate Cancer Patients
Official title: To Investigate the Role of Gut Microbiome in Androgen Deprivation Therapy Related Metabolic Changes in Prostate Cancer Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Prostate Cancer
Lead sponsor: Chinese University of Hong Kong
Sponsor class: OTHER
First posted: 2020-12-29
Enrollment: 50
Sex: MALE
Minimum age (years): 45
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients diagnosed with prostate cancer and is going to receive ADT treatment will be recruited.

Brief summary: Prostate cancer is the second most common cancer in male cancer globally and ranked third in Hong Kong. While androgen deprivation therapy (ADT) is the backbone treatment for advanced prostate cancer, it could lead to obesity, metabolic syndrome and increased cardiovascular mortality. Previous studies showed that ADT patients have different gut microbiome compared to non-ADT patients and the gut microbiome might be related to the metabolic changes. However, the underlying mechanism of these metabolic complications is still not fully understood. This study aims to investigate the relationship and related mechanism between the changes in gut microbiomes and ADT-related metabolic change in prostate cancer patients.

Detailed description: It is a prospective longitudinal observational human study. Fifty prostate cancer patients planned for ADT will be recruited. Fecal sample will be collected before initiation of ADT, and then at 3 and 6 months after initiation of ADT. Anthropometric, blood metabolic parameters, serum inflammation markers and panels of microbiome metabolites will be measured at these timepoints. Changes in gut microbiome from baseline to 6 months after initiation of ADT will be assessed. Correlation of changes in gut microbiome and metabolic changes, as well as inflammation and microbiome metabolites, will be assessed and possible mechanisms will be explored.

Eligibility criteria: Inclusion Criteria:

1. Male subject with age 45 or above
2. Histological diagnosis of prostate cancer (acinar type)
3. Clinically decided for androgen deprivation therapy (ADT) as treatment for prostate cancer

Exclusion Criteria:

1. History of diabetes
2. Patients that have other active treatment for prostate cancer or other cancers (except ADT)
3. Patients received treatment, either surgical or medical, that could lead to decrease in serum testosterone prior to commencement of ADT
4. Patients will be started on other treatments, including chemotherapy, new generation of androgen-receptor targeted agents, radiotherapy etc, within 6 months of the commencement of ADT.
5. Subject with recent antibiotics usage within 3 months.

Primary outcomes:
measure: To assess the changes in gut microbiota in prostate cancer patients after initiation of androgen deprivation therapy (ADT)
timeFrame: Baseline, Month 3, Month 6
Secondary outcomes:
Other outcomes:
Locations:
city: Shatin
country: Hong Kong
facility: Prince of Wales Hospital
Study officials:
affiliation: Chinese University of Hong Kong
name: Chi Fai NG, MD
role: PRINCIPAL_INVESTIGATOR
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