Clinical trial · Observational
The Effect of Androgen Deprivation Therapy on Gut and Urinary Microbiota in Patients With Prostate Cancer
A Cross Sectional Study to Assess the Effect of Androgen Deprivation Therapy on Gut and Urinary Microbiota in Patients With Prostate Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The incidence of prostate cancer is increasing in Hong Kong, as well as that of recurrent or metastatic prostate cancer. Androgen deprivation therapy (ADT) is the standard treatment for recurrent or metastatic prostate cancer, with side effects such as obesity, type 2 diabetes mellitus, metabolic syndrome, osteoporosis and cognitive impairment. With the improvement of treatment, the 5-year survival rate of recurrent and metastatic prostate cancer is up to 20%, and therefore increases the chances of developing such side effects. Due to the introduction of next generation sequencing, investigators have more knowledge of the microbiota in our body, particularly the gut microbiota. Different studies have related gut dysbiosis with obesity, type 2 diabetes mellitus and metabolic syndrome. If investigators can show that ADT is leading to gut dysbiosis, this could be a way in preventing or treating the side effects of ADT. This study aims to identify whether ADT in patients with prostate cancer will have different composition in their gut and urine microbiota.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (2)
- label
- ADT Group
- description
- Participants received continue ADT treatment for at least more than 6 months
- label
- RRP Group
- description
- Participants have radical prostatectomy performed more than 6 months ago.
Primary outcomes (2)
- measure
- Difference in the composition of gut microbiome in prostate cancer patients with or without ADT
- timeFrame
- Baseline (one-time point only)
- description
- Total bacterial DNA was extracted from fecal / urine samples by using the bead-beating method with Qiagen QIAamp DNA Microbiome kit. Extracted DNA will be quantified by Nanodrop for PCR reaction.
- measure
- Difference in the composition of urinary microbiome in prostate cancer patients with or without ADT
- timeFrame
- Baseline (one-time point only)
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Adult patients with age greater than or equal to 18 years old, who are able to provide consent * Patients who was diagnosed to have prostate cancer * Patients either received continue ADT treatment for at least more than 6 months or have radical prostatectomy performed more than 6 months ago. Exclusion Criteria: * Recent use of antibiotics within one month * History of urinary tract infection in preceding year
References
Publications (22)
- BACKGROUNDFang LC, Merrick GS, Wallner KE. Androgen deprivation therapy: a survival benefit or detriment in men with high-risk prostate cancer? Oncology (Williston Park). 2010 Aug;24(9):790-6, 798. PMID 20923031
- BACKGROUNDTaylor LG, Canfield SE, Du XL. Review of major adverse effects of androgen-deprivation therapy in men with prostate cancer. Cancer. 2009 Jun 1;115(11):2388-99. doi: 10.1002/cncr.24283. PMID 19399748
- BACKGROUNDBeauchet O. Testosterone and cognitive function: current clinical evidence of a relationship. Eur J Endocrinol. 2006 Dec;155(6):773-81. doi: 10.1530/eje.1.02306. PMID 17132744
- BACKGROUNDLattouf JB, Saad F. Bone complications of androgen deprivation therapy: screening, prevention, and treatment. Curr Opin Urol. 2010 May;20(3):247-52. doi: 10.1097/MOU.0b013e32833835be. PMID 20224416
- BACKGROUNDSmith MR. Androgen deprivation therapy and risk for diabetes and cardiovascular disease in prostate cancer survivors. Curr Urol Rep. 2008 May;9(3):197-202. doi: 10.1007/s11934-008-0035-y. PMID 18765113
- BACKGROUNDSaylor PJ, Smith MR. Metabolic complications of androgen deprivation therapy for prostate cancer. J Urol. 2009 May;181(5):1998-2006; discussion 2007-8. doi: 10.1016/j.juro.2009.01.047. Epub 2009 Mar 14. PMID 19286225
- BACKGROUNDTeoh 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. PMID 25266491
- BACKGROUNDVemuri R, Gundamaraju R, Shastri MD, Shukla SD, Kalpurath K, Ball M, Tristram S, Shankar EM, Ahuja K, Eri R. Gut Microbial Changes, Interactions, and Their Implications on Human Lifecycle: An Ageing Perspective. Biomed Res Int. 2018 Feb 26;2018:4178607. doi: 10.1155/2018/4178607. eCollection 2018.