NCT03709485

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
150

participants targeted

Target at P50-P75 for not_applicable prostate-cancer

Timeline
Completed

Started Nov 2018

Shorter than P25 for not_applicable prostate-cancer

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 7, 2018

Completed
10 days until next milestone

First Posted

Study publicly available on registry

October 17, 2018

Completed
15 days until next milestone

Study Start

First participant enrolled

November 1, 2018

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2019

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2019

Completed
Last Updated

October 17, 2018

Status Verified

October 1, 2018

Enrollment Period

1 year

First QC Date

October 7, 2018

Last Update Submit

October 16, 2018

Conditions

Prostate Cancer

Keywords

microbiomeprostate cancersequencing

Outcome Measures

Primary Outcomes (2)

  • 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

Study Arms (1)

prostate biopsy patients

EXPERIMENTAL

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.

Interventions

rectal swab for microbial culture.OTHER

Rectal swab and culture.

prostate biopsy patients

Eligibility Criteria

Age45 Years+
Sexmale(Gender-based eligibility)
Gender Eligibility Detailsmales
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • male gender
  • age above 45
  • referred for prostate biopsy

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (3)

  • 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.

    PMID: 30007819BACKGROUND

  • 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.

    PMID: 28888753BACKGROUND

  • 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.

    PMID: 29795140BACKGROUND

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Culture Techniques

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

In Vitro TechniquesInvestigative Techniques

Central Study Contacts

Ran Katz, MD

CONTACT

+972-4-6828775ran.k@ziv.health.gov.il

Talia Simchi

CONTACT

+972-4-6828775Tali.s@ziv.health.gov.il

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 7, 2018

First Posted

October 17, 2018

Study Start

November 1, 2018

Primary Completion

November 1, 2019

Study Completion

December 30, 2019

Last Updated

October 17, 2018

Record last verified: 2018-10

Data Sharing

IPD Sharing
Will not share