To Investigate the Role of Gut Microbiome in ADT Related Metabolic Changes in Prostate Cancer Patients
NCT ID: NCT04687709
Last Updated: 2024-01-05
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
COMPLETED
Total Enrollment
50 participants
Study Classification
OBSERVATIONAL
Study Start Date
2021-01-14
Study Completion Date
2023-09-26
Brief Summary
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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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Detailed Description
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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
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Prostate Cancer
Study Design
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Observational Model Type
COHORT
Study Time Perspective
PROSPECTIVE
Eligibility Criteria
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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
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.
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.
Minimum Eligible Age
45 Years
Eligible Sex
MALE
Accepts Healthy Volunteers
No
Sponsors
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Chinese University of Hong Kong
OTHER
Sponsor Role
lead
Responsible Party
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Chi Fai NG
Professor
Responsibility Role
PRINCIPAL_INVESTIGATOR
Principal Investigators
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Chi Fai NG, MD
Role: PRINCIPAL_INVESTIGATOR
Chinese University of Hong Kong
Locations
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Prince of Wales Hospital
Shatin, , Hong Kong
Site Status
Countries
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Hong Kong
References
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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.
Reference Type
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.
Reference Type
BACKGROUND
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.
Reference Type
BACKGROUND
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.
Reference Type
BACKGROUND
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.
Reference Type
BACKGROUND
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.
Reference Type
BACKGROUND
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.
Reference Type
BACKGROUND
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.
Reference Type
BACKGROUND
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.
Reference Type
BACKGROUND
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.
Reference Type
BACKGROUND
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.
Reference Type
BACKGROUND
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.
Reference Type
BACKGROUND
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.
Reference Type
BACKGROUND
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.
Reference Type
BACKGROUND
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.
Reference Type
BACKGROUND
Zhao H, Chen J, Li X, Sun Q, Qin P, Wang Q. Compositional and functional features of the female premenopausal and postmenopausal gut microbiota. FEBS Lett. 2019 Sep;593(18):2655-2664. doi: 10.1002/1873-3468.13527. Epub 2019 Jul 17.
Reference Type
BACKGROUND
Harada N, Hanaoka R, Horiuchi H, Kitakaze T, Mitani T, Inui H, Yamaji R. Castration influences intestinal microflora and induces abdominal obesity in high-fat diet-fed mice. Sci Rep. 2016 Mar 10;6:23001. doi: 10.1038/srep23001.
Reference Type
BACKGROUND
Gao W, Wu D, Wang Y, Wang Z, Zou C, Dai Y, Ng CF, Teoh JY, Chan FL. Development of a novel and economical agar-based non-adherent three-dimensional culture method for enrichment of cancer stem-like cells. Stem Cell Res Ther. 2018 Sep 26;9(1):243. doi: 10.1186/s13287-018-0987-x.
Reference Type
BACKGROUND
Tsoi TH, Chan CF, Chan WL, Chiu KF, Wong WT, Ng CF, Wong KL. Urinary Polyamines: A Pilot Study on Their Roles as Prostate Cancer Detection Biomarkers. PLoS One. 2016 Sep 6;11(9):e0162217. doi: 10.1371/journal.pone.0162217. eCollection 2016.
Reference Type
BACKGROUND
Teoh JY, Ng CF. Cardiovascular risk after androgen deprivation therapy for prostate cancer: an Asian perspective. Int Urol Nephrol. 2016 Sep;48(9):1429-35. doi: 10.1007/s11255-016-1337-5. Epub 2016 Jun 2.
Reference Type
BACKGROUND
Cheung MK, Lam WY, Fung WY, Law PT, Au CH, Nong W, Kam KM, Kwan HS, Tsui SK. Sputum microbiota in tuberculosis as revealed by 16S rRNA pyrosequencing. PLoS One. 2013;8(1):e54574. doi: 10.1371/journal.pone.0054574. Epub 2013 Jan 24.
Reference Type
BACKGROUND
Hui AW, Lau HW, Chan TH, Tsui SK. The human microbiota: a new direction in the investigation of thoracic diseases. J Thorac Dis. 2013 Aug;5 Suppl 2(Suppl 2):S127-31. doi: 10.3978/j.issn.2072-1439.2013.07.41.
Reference Type
BACKGROUND
Liu Y, Wong KK, Ko EY, Chen X, Huang J, Tsui SK, Li TC, Chim SS. Systematic Comparison of Bacterial Colonization of Endometrial Tissue and Fluid Samples in Recurrent Miscarriage Patients: Implications for Future Endometrial Microbiome Studies. Clin Chem. 2018 Dec;64(12):1743-1752. doi: 10.1373/clinchem.2018.289306. Epub 2018 Sep 20.
Reference Type
BACKGROUND
Chan CWH, Leung TF, Choi KC, Tsui SKW, Chan JYW. Effects of gut microbiome and environment on the development of eczema in Chinese infants. Medicine (Baltimore). 2020 May 22;99(21):e20327. doi: 10.1097/MD.0000000000020327.
Reference Type
BACKGROUND
Wong SH, Yu J. Gut microbiota in colorectal cancer: mechanisms of action and clinical applications. Nat Rev Gastroenterol Hepatol. 2019 Nov;16(11):690-704. doi: 10.1038/s41575-019-0209-8. Epub 2019 Sep 25.
Reference Type
BACKGROUND
Yu J, Feng Q, Wong SH, Zhang D, Liang QY, Qin Y, Tang L, Zhao H, Stenvang J, Li Y, Wang X, Xu X, Chen N, Wu WK, Al-Aama J, Nielsen HJ, Kiilerich P, Jensen BA, Yau TO, Lan Z, Jia H, Li J, Xiao L, Lam TY, Ng SC, Cheng AS, Wong VW, Chan FK, Xu X, Yang H, Madsen L, Datz C, Tilg H, Wang J, Brunner N, Kristiansen K, Arumugam M, Sung JJ, Wang J. Metagenomic analysis of faecal microbiome as a tool towards targeted non-invasive biomarkers for colorectal cancer. Gut. 2017 Jan;66(1):70-78. doi: 10.1136/gutjnl-2015-309800. Epub 2015 Sep 25.
Reference Type
BACKGROUND
Ng CF, Chiu PKF, Yee CH, Lau BSY, Leung SCH, Teoh JYC. Effect of androgen deprivation therapy on cardiovascular function in Chinese patients with advanced prostate cancer: a prospective cohort study. Sci Rep. 2020 Oct 22;10(1):18060. doi: 10.1038/s41598-020-75139-w.
Reference Type
BACKGROUND
Related Links
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https://www3.ha.org.hk/cancereg/topten.html
Hong Kong Cancer Registry.
https://uroweb.org/guideline/prostate-cancer/#6
EAU-EANM-ESTRO-ESUR-SIOG Guidelines on Prostate Cancer 2019
https://www.nccn.org/professionals/physician_gls/PDF/prostate-asia.pdf
27\. NCCN Clinical Practice Guidelines in Oncology - Asia Consensus Statement - version 2.2013.
Other Identifiers
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CRE-2020.603
Identifier Type: -
Identifier Source: org_study_id
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