Prostate Metabolism, Cancer Risk and Gut Microbiota

NCT06116851 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 300

Last updated 2023-11-03

No results posted yet for this study

Summary

This is a prospective, single center translational multiple cohort study to investigate the association of gut microbiota and prostate cancer.

Conditions

Interventions

OTHER

MRI scan and laboratory visit

Prostate MRI scan is performed according to the protocol used in earlier studies (PMID 31158230). In addition to the PCa diagnostics, the scan will include abdominal imaging to body composition analysis (visceral and subcutaneous fat and psoas muscle). Baseline blood and urine samples are collected in Turku University Hospital laboratory.

PROCEDURE

Prostate biopsies

The visit follows routine outpatient clinic protocol. The results from MRI and laboratory findings are discussed and the potential benefits and harms from prostate biopsies are evaluated. After a mutual decision, prostate biopsies are performed.

PROCEDURE

Radical prostatectomy and blood, urine and tissue sampling

Baseline blood and urine samples are collected at the time of surgery. Robotic assisted laparoscopic prostatectomy (RALP) is performed according to routine protocol. Routine diagnostic histopathological procedures will be followed, and study tissue samples are obtained in the department of pathology.

PROCEDURE

TURP and blood, urine and tissue sampling

Baseline blood and urine samples are collected the time of surgery. TURP is performed according to normal protocol. Routine diagnostic histopathological procedures will be followed in the department of pathology. Additionally, tissue samples (a total of 10 resection chips) will be collected for study analyses. Due to the study, no additional tissue samples are removed, i.e. study samples are from the tissues removed as clinically indicated.

PROCEDURE

Radical cystoprostatectomy and blood, urine and tissue sampling

Baseline blood and urine samples are collected at the time of surgery. Radical cystoprostatectomy is performed according to routine protocol. Routine diagnostic histopathological procedures will be followed, and study tissue samples are obtained in the department of pathology.

Sponsors & Collaborators

  • University of Turku

    collaborator OTHER
  • Turku University Hospital

    lead OTHER_GOV

Principal Investigators

  • Peter J. Bostrom, MD, PhD · Turku University Hospital and University of Turku

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-06-01
Primary Completion
2024-01-15
Completion
2026-09-15

Countries

  • Finland

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06116851 on ClinicalTrials.gov