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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
Ziv Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Prostate Cancer focused on measuring microbiome, prostate cancer, sequencing

Eligibility Criteria

45 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

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

    First Posted
    October 7, 2018
    Last Updated
    October 16, 2018
    Sponsor
    Ziv Hospital
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    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
    background
    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
    background

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    Evaluation of Gut Microbiome in Patients With Prostate Cancer

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