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RECRUITING
NCT06116851

Prostate Metabolism, Cancer Risk and Gut Microbiota

Sponsor: Turku University Hospital

View on ClinicalTrials.gov

Summary

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

Key Details

Gender

MALE

Age Range

18 Years - Any

Study Type

OBSERVATIONAL

Enrollment

300

Start Date

2022-06-01

Completion Date

2026-09-15

Last Updated

2023-11-03

Healthy Volunteers

No

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.

Locations (2)

University of Turku

Turku, Finland

Turku University Hospital

Turku, Finland