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

NCT04687709 | Completed

• 1 other identifier: CRE-2020.603
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Prostate Cancer

Outcome Measures

Primary Outcomes (1)

• 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

Eligibility Criteria

• Age: 45 Years+
• Sex: male
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients diagnosed with prostate cancer and is going to receive ADT treatment will be recruited.

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Chinese University of Hong Kong: lead

Study Sites (1)

Prince of Wales Hospital

Shatin, Hong Kong

Location

Related Publications (27)

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Related Links

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

Biospecimen

Retention: SAMPLES WITH DNA

Total bacterial DNA will be extracted from fecal samples by using the bead-beating method with Qiagen QIAamp PowerFecal Pro DNA kit. The extracted DNA will be quantified by Nanodrop for polymerase chain reaction (PCR)

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Officials

• Chi Fai NG, MD

  Chinese University of Hong Kong

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: December 23, 2020
• First Posted: December 29, 2020
• Study Start: January 14, 2021
• Primary Completion: December 6, 2022
• Study Completion: September 26, 2023
• Last Updated: January 5, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

HK (1)