AzTrials
AzTrials

Prostate CancerNCT04687709

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

An observational study of Prostate Cancer, run by Chinese University of Hong Kong at 1 site in Hong Kong.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 45 years and older, men only
Conditions the study is for
Prostate Cancer
How many people
50 participants
Where
1 siteHong Kong
Study dates
14 Jan 2021to 26 Sep 2023
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 45 years and older
  • Men only
  • Adult, Older adult

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

Who may be able to join

  • 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

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Hong Kong1 site

  • Prince of Wales Hospital

    Shatin

Other trials in Hong Kong

About this study

Official title: To Investigate the Role of Gut Microbiome in Androgen Deprivation Therapy 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.

Read the 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.

Conditions
Prostate Cancer
Medical subject headings
Prostatic Neoplasms

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Baseline, Month 3, Month 6

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Dec 2020
  2. Study start14 Jan 2021
  3. Primary completion6 Dec 2022
  4. Study completion26 Sep 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
50 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04687709
Sponsor's protocol ID
CRE-2020.603
Status last verified
Jan 2024
First submitted
23 Dec 2020
Last updated
5 Jan 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 27932742

  • 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.

    PubMed 29110901

  • Wong MC, Goggins WB, Wang HH, Fung FD, Leung C, Wong SY, Ng CF, Sung JJ. Global Incidence and Mortality for Prostate Cancer: Analysis of Temporal Patterns and Trends in 36 Countries. Eur Urol. 2016 Nov;70(5):862-874. doi: 10.1016/j.eururo.2016.05.043. Epub 2016 Jun 8.

    PubMed 27289567

  • Saylor PJ, Smith MR. Adverse effects of androgen deprivation therapy: defining the problem and promoting health among men with prostate cancer. J Natl Compr Canc Netw. 2010 Feb;8(2):211-23. doi: 10.6004/jnccn.2010.0014.

    PubMed 20141678

  • Teoh JY, Chan SY, Chiu PK, Poon DM, Cheung HY, Hou SS, Ng CF. Risk of acute myocardial infarction after androgen-deprivation therapy for prostate cancer in a Chinese population. BJU Int. 2015 Sep;116(3):382-7. doi: 10.1111/bju.12967. Epub 2015 Mar 7.

    PubMed 25327618

  • Teoh JY, Chiu PK, Chan SY, Poon DM, Cheung HY, Hou SS, Ng CF. Risk of ischemic stroke after androgen deprivation therapy for prostate cancer in the Chinese population living in Hong Kong. Jpn J Clin Oncol. 2015 May;45(5):483-7. doi: 10.1093/jjco/hyv025. Epub 2015 Feb 26.

    PubMed 25724216

  • Teoh JY, Chiu PK, Chan SY, Poon DM, Cheung HY, Hou SS, Ng CF. Risk of new-onset diabetes after androgen deprivation therapy for prostate cancer in the Asian population. J Diabetes. 2015 Sep;7(5):672-80. doi: 10.1111/1753-0407.12226. Epub 2014 Dec 22.

    PubMed 25266491

  • Wong SH, Kwong TNY, Wu CY, Yu J. Clinical applications of gut microbiota in cancer biology. Semin Cancer Biol. 2019 Apr;55:28-36. doi: 10.1016/j.semcancer.2018.05.003. Epub 2018 May 18.

    PubMed 29782923

  • Li JKM, Chiu PKF, Ng CF. The impact of microbiome in urological diseases: a systematic review. Int Urol Nephrol. 2019 Oct;51(10):1677-1697. doi: 10.1007/s11255-019-02225-y. Epub 2019 Jul 12.

    PubMed 31301004

  • Ley RE, Turnbaugh PJ, Klein S, Gordon JI. Microbial ecology: human gut microbes associated with obesity. Nature. 2006 Dec 21;444(7122):1022-3. doi: 10.1038/4441022a.

    PubMed 17183309

  • Dabke K, Hendrick G, Devkota S. The gut microbiome and metabolic syndrome. J Clin Invest. 2019 Oct 1;129(10):4050-4057. doi: 10.1172/JCI129194.

    PubMed 31573550

  • Boutagy NE, McMillan RP, Frisard MI, Hulver MW. Metabolic endotoxemia with obesity: Is it real and is it relevant? Biochimie. 2016 May;124:11-20. doi: 10.1016/j.biochi.2015.06.020. Epub 2015 Jun 29.

    PubMed 26133659

  • den Besten G, van Eunen K, Groen AK, Venema K, Reijngoud DJ, Bakker BM. The role of short-chain fatty acids in the interplay between diet, gut microbiota, and host energy metabolism. J Lipid Res. 2013 Sep;54(9):2325-40. doi: 10.1194/jlr.R036012. Epub 2013 Jul 2.

    PubMed 23821742

  • Neuman H, Debelius JW, Knight R, Koren O. Microbial endocrinology: the interplay between the microbiota and the endocrine system. FEMS Microbiol Rev. 2015 Jul;39(4):509-21. doi: 10.1093/femsre/fuu010. Epub 2015 Feb 19.

    PubMed 25701044

  • Santos-Marcos JA, Rangel-Zuniga OA, Jimenez-Lucena R, Quintana-Navarro GM, Garcia-Carpintero S, Malagon MM, Landa BB, Tena-Sempere M, Perez-Martinez P, Lopez-Miranda J, Perez-Jimenez F, Camargo A. Influence of gender and menopausal status on gut microbiota. Maturitas. 2018 Oct;116:43-53. doi: 10.1016/j.maturitas.2018.07.008. Epub 2018 Jul 19.

    PubMed 30244778

Questions about this trial

What is this clinical trial studying?

An observational study of Prostate Cancer, run by Chinese University of Hong Kong at 1 site in Hong Kong.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 5 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04687709, which also lists 27 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jan 2024.

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