Evaluation of Gut Microbiome in Patients With Prostate Cancer
- Conditions
- Prostate Cancer
- Interventions
- Other: rectal swab for microbial culture.
- Registration Number
- NCT03709485
- Lead Sponsor
- Ziv Hospital
- 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- Male
- Target Recruitment
- 150
- male gender
- age above 45
- referred for prostate biopsy
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description prostate biopsy patients rectal swab for microbial culture. 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.
- Primary Outcome Measures
Name Time Method Characterization of gut microbiome 1 year Analysis of rectal swab cultures.
Association of prostate cancer patients and specific microbes. 1 year Relationship between patients with prostate cancer and specific strains of rectal microbes
- Secondary Outcome Measures
Name Time Method