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出境医 / 临床实验 / Urinary and Prostate Microbiotes and Prostate Cancer (MICROPROSTK)

Urinary and Prostate Microbiotes and Prostate Cancer (MICROPROSTK)

Study Description
Brief Summary:

In recent decades, the cancer process has been linked to microbial infections, particularly in gastric and Helicobacter pylori cancers, but also in cervical cancers promoted by exposure to Human papilloma virus (HPV). More recently, it has been shown that bacteria in the intestinal microbiota could promote the development of colorectal cancer by modulating the inflammatory response within the intestinal mucosa. Among male cancers, prostate cancer is the leading cause in France with 54,000 new cases per year. In addition, the dogma that urine is sterile has been broken and the notion of the presence of a "urinary microbiota" in asymptomatic patients is now accepted.

While the risk factors associated with this cancer have not yet been clearly elucidated, recent evidence in the literature agrees that chronic inflammation associated with prostate infection plays a key role as a factor that may promote the development and/or progression of prostate cancer. Most recently, a study shows for the first time that a group of 6 bacteria is found significantly higher in the urine of patients with prostate cancer than in patients with prostate adenoma. Interestingly, clinical microbiology studies conducted at the bacteriology laboratory of the University Hospital of Nice on A. schaalii have shown that this species is also isolated in the urine of patients with bladder and prostate cancers.

The investigators wish to study the association of the 6 bacterial species mentioned above with prostate cancer by directly analyzing the prostate tissue of patients with this condition.

the staff will carry out a multicenter case-control study by recruiting a total of 260 patients in 4 centres (Nice coordinating centre, Marseille, Tours and Nîmes): 130 in the prostate cancer group and 130 in the prostate adenoma control group. This project is a research involving the human person of category 2.

The innovative aspect of the work consists in detecting and quantifying in situ in the prostate tissue the presence of these 6 bacterial species per culture and per PCR in real time, comparing the prostate microbiota in terms of richness and diversity between cancer patients and those without cancer. Ultimately, this study opens up exciting prospects with the possibility of determining a microbial origin of prostate cancer and considering antibiotic therapy for anti-cancer purposes such as H. pylori and gastric cancer.


Condition or disease Intervention/treatment Phase
Prostatic Neoplasm Procedure: prostate biopsy Other: Urinary sampling Other: Rectal swabbing before biopsies are performed Not Applicable

Study Design
Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 260 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Urinary and Prostate Microbiotes and Prostate Cancer
Actual Study Start Date : February 15, 2021
Estimated Primary Completion Date : October 15, 2022
Estimated Study Completion Date : October 15, 2023
Arms and Interventions
Arm Intervention/treatment
Experimental: cancer group Procedure: prostate biopsy
All patients included, will report to the urology department on the date previously agreed with the surgeon. The patient will be seen by the nurse and urologist on duty as part of outpatient care or, more rarely, in ambulatory care. After verification of the patient's identity, the signature of informed consent, the absence of immediate contraindications to biopsy (haemorrhagic and infectious) and the patient's proper preparation (antibiotic prophylaxis and possible enema), the patient will be installed for the taking of samples covered by the protocol (rectal swabbing and prostate biopsies, see paragraph IX). If the patient has not taken the antibiotic prophylaxis or performed the enema, he or she will be reconvened at a later date for the biopsies. After the prostatic biopsies have been performed, the patient's participation in the study ends and his follow-up resumes according to the recommendations adapted to his pathology.

Other: Urinary sampling
It will be collected after the prostate massage performed by the surgeon in charge of the patient during his clinical examination for prostate cancer screening. After elimination of the first draft, the urine will be collected in 2 tubes with borated preservative

Other: Rectal swabbing before biopsies are performed
A rectal swab will then be taken by the urologist on the day the prostate biopsies are taken. The analysis of the digestive microbiota will eliminate contamination of prostate biopsies by bacteria from the faecal flora during transrectal sampling

Experimental: control group Procedure: prostate biopsy
All patients included, will report to the urology department on the date previously agreed with the surgeon. The patient will be seen by the nurse and urologist on duty as part of outpatient care or, more rarely, in ambulatory care. After verification of the patient's identity, the signature of informed consent, the absence of immediate contraindications to biopsy (haemorrhagic and infectious) and the patient's proper preparation (antibiotic prophylaxis and possible enema), the patient will be installed for the taking of samples covered by the protocol (rectal swabbing and prostate biopsies, see paragraph IX). If the patient has not taken the antibiotic prophylaxis or performed the enema, he or she will be reconvened at a later date for the biopsies. After the prostatic biopsies have been performed, the patient's participation in the study ends and his follow-up resumes according to the recommendations adapted to his pathology.

Other: Urinary sampling
It will be collected after the prostate massage performed by the surgeon in charge of the patient during his clinical examination for prostate cancer screening. After elimination of the first draft, the urine will be collected in 2 tubes with borated preservative

Other: Rectal swabbing before biopsies are performed
A rectal swab will then be taken by the urologist on the day the prostate biopsies are taken. The analysis of the digestive microbiota will eliminate contamination of prostate biopsies by bacteria from the faecal flora during transrectal sampling

Outcome Measures
Primary Outcome Measures :
  1. Number of 6 bacterial species in prostate biopsy [ Time Frame: 48 months ]
    detection in prostate biopsy by real-time PCR and/or culture followed by identification by MALDI-TOF mass spectrometry of at least one of the following 6 bacterial species : S. anginosus, V. cambriense, P. lymphophilum, A. lactolyticus, A. obesiensis and A. schaalii.


Eligibility Criteria
Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • over 18 years old
  • Male sex
  • Patient with a prostate biopsy programmed for suspected prostate adenocarcinoma on elevation of PSA and/or TR suspect and/or MRI suspect
  • Signed Informed Consent
  • Affiliation to a social security system

Exclusion Criteria:

  • Taking systemic antibiotic treatment (per os or I.V.) within 3 months before inclusion.
  • Contraindications to the performance of an ultrasound-guided transrectal prostate biopsy: coagulation disorders and urogenital infections.
  • History of surgical treatment of the urinary and genital tract within 6 months before inclusion
  • Person under guardianship, curatorship or unable to express consent.
Contacts and Locations

Contacts
Layout table for location contacts
Contact: romain LOTTE 33492036218 lotte.r@chu-nice.fr

Locations
Layout table for location information
France
Cannes hospital Recruiting
Cannes, France, 06400
Contact: romain Lotte    0492036218    lotte.r@chu-nice.fr   
Contact: Aysha Shaikh       shaikh.a@chu-nice.fr   
Principal Investigator: romain haider         
Principal Investigator: yohan bodokh         
Principal Investigator: patrick-julien treacy         
marseille Hospital Recruiting
Marseille, France, 13000
Contact: eric Lechevallier    0491435188    elechevallier@ap-hm.fr   
Principal Investigator: erci Lechevallier         
nice Hospital Recruiting
Nice, France, 06000
Contact: romain LOTTE    33492036218    lotte.r@chu-nice.fr   
Principal Investigator: durand Matthieu         
Tours hospital Recruiting
Tours, France, 37000
Contact: Franck Bruyere    02 34 38 95 42    F.BRUYERE@chu-tours.fr   
Principal Investigator: franck Bruyere         
Sponsors and Collaborators
Centre Hospitalier Universitaire de Nice
Tracking Information
First Submitted Date  ICMJE May 9, 2019
First Posted Date  ICMJE May 13, 2019
Last Update Posted Date May 3, 2021
Actual Study Start Date  ICMJE February 15, 2021
Estimated Primary Completion Date October 15, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 13, 2019)
Number of 6 bacterial species in prostate biopsy [ Time Frame: 48 months ]
detection in prostate biopsy by real-time PCR and/or culture followed by identification by MALDI-TOF mass spectrometry of at least one of the following 6 bacterial species : S. anginosus, V. cambriense, P. lymphophilum, A. lactolyticus, A. obesiensis and A. schaalii.
Original Primary Outcome Measures  ICMJE
 (submitted: May 10, 2019)
detection in prostate biopsy of at least one of the following 6 bacterial species [ Time Frame: 48 months ]
detection in prostate biopsy by real-time PCR and/or culture followed by identification by MALDI-TOF mass spectrometry of at least one of the following 6 bacterial species : S. anginosus, V. cambriense, P. lymphophilum, A. lactolyticus, A. obesiensis and A. schaalii.
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Urinary and Prostate Microbiotes and Prostate Cancer
Official Title  ICMJE Urinary and Prostate Microbiotes and Prostate Cancer
Brief Summary

In recent decades, the cancer process has been linked to microbial infections, particularly in gastric and Helicobacter pylori cancers, but also in cervical cancers promoted by exposure to Human papilloma virus (HPV). More recently, it has been shown that bacteria in the intestinal microbiota could promote the development of colorectal cancer by modulating the inflammatory response within the intestinal mucosa. Among male cancers, prostate cancer is the leading cause in France with 54,000 new cases per year. In addition, the dogma that urine is sterile has been broken and the notion of the presence of a "urinary microbiota" in asymptomatic patients is now accepted.

While the risk factors associated with this cancer have not yet been clearly elucidated, recent evidence in the literature agrees that chronic inflammation associated with prostate infection plays a key role as a factor that may promote the development and/or progression of prostate cancer. Most recently, a study shows for the first time that a group of 6 bacteria is found significantly higher in the urine of patients with prostate cancer than in patients with prostate adenoma. Interestingly, clinical microbiology studies conducted at the bacteriology laboratory of the University Hospital of Nice on A. schaalii have shown that this species is also isolated in the urine of patients with bladder and prostate cancers.

The investigators wish to study the association of the 6 bacterial species mentioned above with prostate cancer by directly analyzing the prostate tissue of patients with this condition.

the staff will carry out a multicenter case-control study by recruiting a total of 260 patients in 4 centres (Nice coordinating centre, Marseille, Tours and Nîmes): 130 in the prostate cancer group and 130 in the prostate adenoma control group. This project is a research involving the human person of category 2.

The innovative aspect of the work consists in detecting and quantifying in situ in the prostate tissue the presence of these 6 bacterial species per culture and per PCR in real time, comparing the prostate microbiota in terms of richness and diversity between cancer patients and those without cancer. Ultimately, this study opens up exciting prospects with the possibility of determining a microbial origin of prostate cancer and considering antibiotic therapy for anti-cancer purposes such as H. pylori and gastric cancer.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Condition  ICMJE Prostatic Neoplasm
Intervention  ICMJE
  • Procedure: prostate biopsy
    All patients included, will report to the urology department on the date previously agreed with the surgeon. The patient will be seen by the nurse and urologist on duty as part of outpatient care or, more rarely, in ambulatory care. After verification of the patient's identity, the signature of informed consent, the absence of immediate contraindications to biopsy (haemorrhagic and infectious) and the patient's proper preparation (antibiotic prophylaxis and possible enema), the patient will be installed for the taking of samples covered by the protocol (rectal swabbing and prostate biopsies, see paragraph IX). If the patient has not taken the antibiotic prophylaxis or performed the enema, he or she will be reconvened at a later date for the biopsies. After the prostatic biopsies have been performed, the patient's participation in the study ends and his follow-up resumes according to the recommendations adapted to his pathology.
  • Other: Urinary sampling
    It will be collected after the prostate massage performed by the surgeon in charge of the patient during his clinical examination for prostate cancer screening. After elimination of the first draft, the urine will be collected in 2 tubes with borated preservative
  • Other: Rectal swabbing before biopsies are performed
    A rectal swab will then be taken by the urologist on the day the prostate biopsies are taken. The analysis of the digestive microbiota will eliminate contamination of prostate biopsies by bacteria from the faecal flora during transrectal sampling
Study Arms  ICMJE
  • Experimental: cancer group
    Interventions:
    • Procedure: prostate biopsy
    • Other: Urinary sampling
    • Other: Rectal swabbing before biopsies are performed
  • Experimental: control group
    Interventions:
    • Procedure: prostate biopsy
    • Other: Urinary sampling
    • Other: Rectal swabbing before biopsies are performed
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: May 10, 2019)
260
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE October 15, 2023
Estimated Primary Completion Date October 15, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • over 18 years old
  • Male sex
  • Patient with a prostate biopsy programmed for suspected prostate adenocarcinoma on elevation of PSA and/or TR suspect and/or MRI suspect
  • Signed Informed Consent
  • Affiliation to a social security system

Exclusion Criteria:

  • Taking systemic antibiotic treatment (per os or I.V.) within 3 months before inclusion.
  • Contraindications to the performance of an ultrasound-guided transrectal prostate biopsy: coagulation disorders and urogenital infections.
  • History of surgical treatment of the urinary and genital tract within 6 months before inclusion
  • Person under guardianship, curatorship or unable to express consent.
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: romain LOTTE 33492036218 lotte.r@chu-nice.fr
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03947515
Other Study ID Numbers  ICMJE 18-API-02
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Centre Hospitalier Universitaire de Nice
Study Sponsor  ICMJE Centre Hospitalier Universitaire de Nice
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Centre Hospitalier Universitaire de Nice
Verification Date April 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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