Evaluation of Gut Microbiome in Patients With Prostate Cancer

Study Overview
=================
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.

Official Title
-----------------
Analysis of Gut Microbiome in Prostate Cancer Patients

Conditions
-----------------
Prostate Cancer

Intervention / Treatment
-----------------
* Other: rectal swab for microbial culture.


Participation Criteria
=================
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.

Ages Eligible for Study
-----------------
Minimum Age: 45 Years

Sexes Eligible for Study
-----------------
Male

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Basic Science
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: prostate biopsy patients<br>a cohort o consecutive patients referred to prostate biopsies. In all patients, a rectal swab will be taken prior to biopsy and antimicrobial treatment. The swab will be cultured and analyzed in the lab for characterization of the microbiome. | Other: rectal swab for microbial culture.<br>* Rectal swab and culture.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Characterization of gut microbiome | Analysis of rectal swab cultures. | 1 year | 
| Association of prostate cancer patients and specific microbes. | Relationship between patients with prostate cancer and specific strains of rectal microbes | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
microbiome, prostate cancer, sequencing