Urinary and Prostate Microbiotes and Prostate Cancer

Not Applicable

Completed

• Conditions: Prostatic Neoplasm
• Interventions: Procedure: prostate biopsy; Other: Urinary sampling; Other: Rectal swabbing before biopsies are performed

• Registration Number: NCT03947515
• Lead Sponsor: Centre Hospitalier Universitaire de Nice

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 available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2019-05-09
• Study First Submitted QC: 2019-05-10
• Study First Posted: 2019-05-13
• Study Start: 2021-02-04
• Primary Completion: 2022-10-04
• Study Completion: 2023-06-22
• Status Verified: 2023-12
• Last Update Submitted: 2023-12-01
• Last Update Posted: 2023-12-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 296

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

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
control group	Urinary sampling	-
cancer group	Rectal swabbing before biopsies are performed	-
control group	prostate biopsy	-
cancer group	prostate biopsy	-
cancer group	Urinary sampling	-
control group	Rectal swabbing before biopsies are performed	-

Primary Outcome Measures

Name	Time	Method
Number of 6 bacterial species in prostate biopsy	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.

Trial Locations

Locations (4)

Cannes hospital; 🇫🇷 Cannes, France

marseille Hospital; 🇫🇷 Marseille, France

nice Hospital; 🇫🇷 Nice, France

Tours hospital; 🇫🇷 Tours, France