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

Prostate Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04687709
• Other study ID #: CRE-2020.603
• Status: Completed
• Start date: January 14, 2021
• Est. completion date: September 26, 2023

Study information

• Verified date: January 2024
• Source: Chinese University of Hong Kong
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: September 26, 2023
• Est. primary completion date: December 6, 2022
• Gender: Male
• Age group: 45 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Locations

Country	Name	City	State
Hong Kong	Prince of Wales Hospital	Shatin

Sponsors (1)

Lead Sponsor	Collaborator
Chinese University of Hong Kong

Country where clinical trial is conducted

Hong Kong, 

References & Publications (27)

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* Note: There are 27 references in all — Click here to view all references

Outcome

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

External Links

•   27. NCCN Clinical Practice Guidelines in Oncology - Asia Consensus Statement - version 2.2013.
•   EAU-EANM-ESTRO-ESUR-SIOG Guidelines on Prostate Cancer 2019
•   Globoscan 2018
•   Hong Kong Cancer Registry.