To Investigate the Role of Gut Microbiome in ADT Related... | NCT04687709

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

NCT04687709

Sponsor

Chinese University of Hong Kong

Status

Completed

Last Update Posted

Jan 5, 2024Actual

Enrollment

50Actual

Phase

Not provided

Conditions

Prostate Cancer

Interventions

Not provided

Countries

Hong Kong

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2024

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 14, 2021Actual

Primary Completion Date

Dec 6, 2022Actual

Completion Date

Sep 26, 2023Actual

First Submitted Date

Dec 23, 2020

First Submission Date that Met QC Criteria

Dec 23, 2020

First Posted Date

Dec 29, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 3, 2024

Last Update Posted Date

Jan 5, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

50Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Not provided

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

45 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Chi Fai NG, MD	Chinese University of Hong Kong	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Prince of Wales Hospital		Shatin			Hong Kong

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
27932742	Background	Chan SY, Ng CF, Lee KW, Yee CH, Chiu PK, Teoh JY, Hou SS. Differences in cancer characteristics of Chinese patients with prostate cancer who present with different symptoms. Hong Kong Med J. 2017 Feb;23(1):6-12. doi: 10.12809/hkmj164875. Epub 2016 Dec 9.
29110901	Background	Dao MC, Clement K. Gut microbiota and obesity: Concepts relevant to clinical care. Eur J Intern Med. 2018 Feb;48:18-24. doi: 10.1016/j.ejim.2017.10.005. Epub 2017 Oct 27.

ID	Term
D005834	Genital Neoplasms, Male
D014565	Urogenital Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms