Clinical trial · Interventional
Evaluation of Gut Microbiome in Patients With Prostate Cancer
Analysis of Gut Microbiome in Prostate Cancer Patients
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| rectal swab for microbial culture. | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- prostate biopsy patients
- 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.
- interventionNames
- Other: rectal swab for microbial culture.
Primary outcomes (2)
- measure
- Characterization of gut microbiome
- timeFrame
- 1 year
- description
- Analysis of rectal swab cultures.
- measure
- Association of prostate cancer patients and specific microbes.
- timeFrame
- 1 year
- description
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 45 Years
Show eligibility criteria text
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.
References
Publications (3)
- BACKGROUNDLiss 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 30007819
- BACKGROUNDGolombos 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 28888753
- BACKGROUNDPorter 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 29795140