Evaluation of Gut Microbiome in Patients With Prostate Cancer

Prostate Cancer Clinical Trial

Official title:

Analysis of Gut Microbiome in Prostate Cancer Patients

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03709485
• Other study ID #: 0094-17CTIL
• Status: Not yet recruiting
• Phase: N/A
• Start date: November 1, 2018
• Est. completion date: December 30, 2019

Study information

• Verified date: October 2018
• Source: Ziv Hospital
• Contact: Ran Katz, MD
• Phone: +972-4-6828775
• Email: ran.k[@]ziv.health.gov.il
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The research will focus on the possible connection between prostate cancer, and various species of bacteria in the large intestine. In consecutive patients, referred to prostate biopsies, rectal swabs will be taken before the biopsies and before antibiotic treatment. The gut flora will be examined and characterized by a microbiome analysis tool. Negative patients will serve as internal control. The investigators will look for association between prostate cancer of various grades and the presence of specific enteropathogens in the rectal flora of the participants.

Description:

Prostate cancer is the no. 1 cancer among men. Risk factors include Afro-American origin, prostate cancer in a first degree relatives and the presence of BRCA2 genetic mutations. No specific association has been described yet between prostate cancer and specific gut bacteria.

The GI tract is the home of billions of bacteria. The microbiome functions as a separate organ and contains 10 times the amount of genes compared to the human genome. The microbiome has crucial impact on the human metabolism, inflammatory processes and filtration of GI content. All of these effects may contribute to the exposure of the human body to various carcinogens and inflammatory factors, leading eventually to the development of cancer in remote organs.

The purpose of this research is to try and identify specific species that might be related to the development of prostate cancer.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 150
• Est. completion date: December 30, 2019
• Est. primary completion date: November 1, 2019
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 45 Years and older

Eligibility

Inclusion Criteria:

• male gender

• age above 45

• referred for prostate biopsy

Exclusion Criteria:

• age below 45

• antimicrobial therapy in the 7 days prior to biopsy

• previous prostate or pelvic irradiation

• patients who suffer from inflammatory bowel disease

• systemic chemotherapy for any reason in the 3 months prior to the biopsy.

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Other:
• rectal swab for microbial culture.
Rectal swab and culture.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Ziv Hospital

References & Publications (3)

Golombos DM, Ayangbesan A, O'Malley P, Lewicki P, Barlow L, Barbieri CE, Chan C, DuLong C, Abu-Ali G, Huttenhower C, Scherr DS. The Role of Gut Microbiome in the Pathogenesis of Prostate Cancer: A Prospective, Pilot Study. Urology. 2018 Jan;111:122-128. doi: 10.1016/j.urology.2017.08.039. Epub 2017 Sep 6. — View Citation

Liss MA, White JR, Goros M, Gelfond J, Leach R, Johnson-Pais T, Lai Z, Rourke E, Basler J, Ankerst D, Shah DP. Metabolic Biosynthesis Pathways Identified from Fecal Microbiome Associated with Prostate Cancer. Eur Urol. 2018 Nov;74(5):575-582. doi: 10.1016/j.eururo.2018.06.033. Epub 2018 Jul 12. — View Citation

Porter CM, Shrestha E, Peiffer LB, Sfanos KS. The microbiome in prostate inflammation and prostate cancer. Prostate Cancer Prostatic Dis. 2018 Sep;21(3):345-354. doi: 10.1038/s41391-018-0041-1. Epub 2018 May 23. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Characterization of gut microbiome	Analysis of rectal swab cultures.	1 year
Primary	Association of prostate cancer patients and specific microbes.	Relationship between patients with prostate cancer and specific strains of rectal microbes	1 year