Prostate Metabolism, Cancer Risk and Gut Microbiota
NCT06116851 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 300
Last updated 2023-11-03
Summary
This is a prospective, single center translational multiple cohort study to investigate the association of gut microbiota and prostate cancer.
Conditions
- Prostate Cancer
- Prostate Hyperplasia
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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