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

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.

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Key information

Conditions

Prostate Cancer Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasms Neoplasms by Site Prostatic Diseases Prostatic Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

45 year and older

Sex eligibility

Male

Study type

Observational

Primary location

Prince of Wales Hospital

Shatin, Hong Kong

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

History of diabetes
Patients that have other active treatment for prostate cancer or other cancers (except ADT)
Patients received treatment, either surgical or medical, that could lead to decrease in serum testosterone prior to commencement of ADT
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.
Subject with recent antibiotics usage within 3 months.

Treatment and study plan

Primary outcomes

To assess the changes in gut microbiota in prostate cancer patients after initiation of androgen deprivation therapy (ADT)

Time frame: Baseline, Month 3, Month 6

Gut microbiome related metabolites will be measured by ELISA and mass spectrometry.

Sponsors and collaborators

Lead sponsor

Chinese University of Hong Kong

Other

Registry information

Official study title

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

Important dates

Study start: 2021
Primary completion: 2022
Study completion: 2023
First posted: Dec 29, 2020
Registry last updated: Jan 5, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed