Clinical trial NCT03709485: Evaluation of Gut Microbiome in Patients With Prostate Cancer
Official title: Analysis of Gut Microbiome in Prostate Cancer Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Prostate Cancer
Keywords: microbiome
prostate cancer
sequencing
Lead sponsor: Ziv Hospital
Sponsor class: OTHER_GOV
First posted: 2018-10-17
Enrollment: 150
Sex: MALE
Minimum age (years): 45
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Characterization of gut microbiome
timeFrame: 1 year
measure: Association of prostate cancer patients and specific microbes.
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
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.
citation: 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.
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.