The Effect of Androgen Deprivation Therapy on Gut and Urinary Microbiota in Patients With Prostate Cancer

NCT03888742 | Completed

• 1 other identifier: CRE 2018.280
• Study Type: observational
• Target: 214
• Locations: 1 country
• Sites: 1

Brief Summary

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

Prostate Cancer

Outcome Measures

Primary Outcomes (2)

• Difference in the composition of gut microbiome in prostate cancer patients with or without ADT

  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.

  Baseline (one-time point only)

• Difference in the composition of urinary microbiome in prostate cancer patients with or without ADT

  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.

  Baseline (one-time point only)

Study Arms (2)

ADT Group

Participants received continue ADT treatment for at least more than 6 months

RRP Group

Participants have radical prostatectomy performed more than 6 months ago.

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

300 Patients (150 patients with ADT usage and 150 patients with radical prostatectomy done) who fulfilled the above inclusion criteria with no exclusion criteria will be recruited for the study.

You may qualify if:

• 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.

You may not qualify if:

• Recent use of antibiotics within one month
• History of urinary tract infection in preceding year

Sponsors & Collaborators

• Chinese University of Hong Kong: lead

Study Sites (1)

Prince of Wales Hospital

Shatin, Hong Kong

Location

Related Publications (22)

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Biospecimen

Retention: SAMPLES WITH DNA

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.

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: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 21, 2019
• First Posted: March 25, 2019
• Study Start: November 12, 2018
• Primary Completion: June 7, 2021
• Study Completion: June 7, 2021
• Last Updated: December 16, 2021

Record last verified: 2021-12

Locations

HK (1)