Urinary and Prostate Microbiotes and Prostate Cancer (MICROPROSTK)
Primary Purpose
Prostatic Neoplasm
Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
prostate biopsy
Urinary sampling
Rectal swabbing before biopsies are performed
Sponsored by
About this trial
This is an interventional basic science trial for Prostatic Neoplasm
Eligibility 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.
Sites / Locations
- Cannes hospitalRecruiting
- marseille HospitalRecruiting
- nice HospitalRecruiting
- Tours hospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
cancer group
control group
Arm Description
Outcomes
Primary Outcome Measures
Number of 6 bacterial species in prostate biopsy
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT03947515
First Posted
May 9, 2019
Last Updated
May 13, 2022
Sponsor
Centre Hospitalier Universitaire de Nice
1. Study Identification
Unique Protocol Identification Number
NCT03947515
Brief Title
Urinary and Prostate Microbiotes and Prostate Cancer
Acronym
MICROPROSTK
Official Title
Urinary and Prostate Microbiotes and Prostate Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
May 2022
Overall Recruitment Status
Recruiting
Study Start Date
February 15, 2021 (Actual)
Primary Completion Date
October 15, 2022 (Anticipated)
Study Completion Date
October 15, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire de Nice
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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostatic Neoplasm
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
260 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
cancer group
Arm Type
Experimental
Arm Title
control group
Arm Type
Experimental
Intervention Type
Procedure
Intervention Name(s)
prostate biopsy
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Urinary sampling
Intervention Description
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
Intervention Type
Other
Intervention Name(s)
Rectal swabbing before biopsies are performed
Intervention Description
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
Primary Outcome Measure Information:
Title
Number of 6 bacterial species in prostate biopsy
Description
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.
Time Frame
48 months
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
romain LOTTE
Phone
33492036218
Email
lotte.r@chu-nice.fr
Facility Information:
Facility Name
Cannes hospital
City
Cannes
ZIP/Postal Code
06400
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
romain Lotte
Phone
0492036218
Email
lotte.r@chu-nice.fr
First Name & Middle Initial & Last Name & Degree
Aysha Shaikh
Email
shaikh.a@chu-nice.fr
First Name & Middle Initial & Last Name & Degree
romain haider
First Name & Middle Initial & Last Name & Degree
yohan bodokh
First Name & Middle Initial & Last Name & Degree
patrick-julien treacy
Facility Name
marseille Hospital
City
Marseille
ZIP/Postal Code
13000
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
eric Lechevallier
Phone
0491435188
Email
elechevallier@ap-hm.fr
First Name & Middle Initial & Last Name & Degree
erci Lechevallier
Facility Name
nice Hospital
City
Nice
ZIP/Postal Code
06000
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
romain LOTTE
Phone
33492036218
Email
lotte.r@chu-nice.fr
First Name & Middle Initial & Last Name & Degree
durand Matthieu
Facility Name
Tours hospital
City
Tours
ZIP/Postal Code
37000
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Franck Bruyere
Phone
02 34 38 95 42
Email
F.BRUYERE@chu-tours.fr
First Name & Middle Initial & Last Name & Degree
franck Bruyere
12. IPD Sharing Statement
Plan to Share IPD
No
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Urinary and Prostate Microbiotes and Prostate Cancer
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