To Investigate the Role of Gut Microbiome in ADT Related Metabolic Changes in Prostate Cancer Patients

To Investigate the Role of Gut Microbiome in Androgen Deprivation Therapy Related Metabolic Changes in Prostate Cancer Patients

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04687709

Enrollment

Registered

2020-12-29

Start date

2021-01-14

Completion date

2023-09-26

Last updated

2024-01-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prostate Cancer

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

MALE

Age

45 Years to No maximum

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.

Design outcomes

Primary

Measure	Time frame	Description
To assess the changes in gut microbiota in prostate cancer patients after initiation of androgen deprivation therapy (ADT)	Baseline, Month 3, Month 6	Gut microbiome related metabolites will be measured by ELISA and mass spectrometry.

Countries

Hong Kong

Outcome results