Clinical trial · Observational
Prostate Metabolism, Cancer Risk and Gut Microbiota
NCT06116851CI-TRIAL-00071052PROMICrecruitingClinicalTrials.gov clinicaltrialsProvenance
- 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)
This is a prospective, single center translational multiple cohort study to investigate the association of gut microbiota and prostate cancer.
Conditions
Conditions (2)
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 |
| Prostate Hyperplasia | — | UNRESOLVED | — |
Interventions
Interventions (5)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| MRI scan and laboratory visit | Other | — | UNRESOLVED |
| Prostate biopsies | Procedure | — | UNRESOLVED |
| Radical cystoprostatectomy and blood, urine and tissue sampling | Procedure | — | UNRESOLVED |
| Radical prostatectomy and blood, urine and tissue sampling | Procedure | — | UNRESOLVED |
| TURP and blood, urine and tissue sampling | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (4)
- label
- suspicion
- description
- Inclusion criteria for the suspicion cohort include clinical suspicion for PCa and indication for PCA diagnostics based on any of the following: 1) elevated PSA (\>2.5 ng/ml), 2) palpable prostate tumor/nodule, 3) image finding suggestive of PCa. The suspicion cohort will include a total of 300 subjects who will undergo PCa diagnostics including prostate MRI, and transrectal ultrasound (TRUS) guided prostate biopsies. After the diagnostic procedures all subjects are categorized to one of the following groups: 1) subject without PCa, 2) subject with clinically non-significant PCa (ISUP grade 1/Gleason 3+3), 3) clinically significant PCa (ISUP grade \>1/\>Gleason 3+3). Based on the outcome of the PCa diagnostics and planned clinical treatment, subjects may be eligible to other cohorts as well.
- interventionNames
- Other: MRI scan and laboratory visit
- Procedure: Prostate biopsies
- label
- cancer (radical prostatectomy) cohort
- description
- Inclusion criteria for the cancer cohort include clinically significant prostate cancer planned to be treated with radical prostatectomy with or without pelvic lymph node dissection. The cancer cohort will include a total of 50 subjects.
- interventionNames
- Procedure: Radical prostatectomy and blood, urine and tissue sampling
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Provision of signed and dated informed consent form. * Ability and stated willingness to comply with all study procedures and availability for the duration of the study. Exclusion Criteria: * inability to comply with study procedures or unwillingness to participate in the study.
References
Publications (1)
pubmedProvenance
- Source
- PubMed (NLM)
- Dataset
- PubMed E-utilities
- Retrieved
- Sep 9, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
Elja Heiskanen, Sofia Kalinen, Rui Jian Chu et al. · Scand J Urol · Sep 8, 2026 · PMID 42707024 pubmed