Evaluation of Gut Microbiome in Patients With Prostate Cancer
Primary Purpose
Prostate Cancer
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
rectal swab for microbial culture.
Sponsored by
About this trial
This is an interventional basic science trial for Prostate Cancer focused on measuring microbiome, prostate cancer, sequencing
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.
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
prostate biopsy patients
Arm Description
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.
Outcomes
Primary Outcome Measures
Characterization of gut microbiome
Analysis of rectal swab cultures.
Association of prostate cancer patients and specific microbes.
Relationship between patients with prostate cancer and specific strains of rectal microbes
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03709485
Brief Title
Evaluation of Gut Microbiome in Patients With Prostate Cancer
Official Title
Analysis of Gut Microbiome in Prostate Cancer Patients
Study Type
Interventional
2. Study Status
Record Verification Date
October 2018
Overall Recruitment Status
Unknown status
Study Start Date
November 1, 2018 (Anticipated)
Primary Completion Date
November 1, 2019 (Anticipated)
Study Completion Date
December 30, 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ziv Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer
Keywords
microbiome, prostate cancer, sequencing
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
150 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
prostate biopsy patients
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
rectal swab for microbial culture.
Intervention Description
Rectal swab and culture.
Primary Outcome Measure Information:
Title
Characterization of gut microbiome
Description
Analysis of rectal swab cultures.
Time Frame
1 year
Title
Association of prostate cancer patients and specific microbes.
Description
Relationship between patients with prostate cancer and specific strains of rectal microbes
Time Frame
1 year
10. Eligibility
Sex
Male
Gender Based
Yes
Gender Eligibility Description
males
Minimum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ran Katz, MD
Phone
+972-4-6828775
Email
ran.k@ziv.health.gov.il
First Name & Middle Initial & Last Name or Official Title & Degree
Talia Simchi
Phone
+972-4-6828775
Email
Tali.s@ziv.health.gov.il
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
30007819
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.
Results Reference
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PubMed Identifier
28888753
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.
Results Reference
background
PubMed Identifier
29795140
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.
Results Reference
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Evaluation of Gut Microbiome in Patients With Prostate Cancer
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