RecruitingNCT06116851

Prostate Metabolism, Cancer Risk and Gut Microbiota


Sponsor

Turku University Hospital

Enrollment

300 participants

Start Date

Jun 1, 2022

Study Type

OBSERVATIONAL

Conditions

Summary

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


Eligibility

Sex: MALEMin Age: 18 Years

Inclusion Criteria2

  • 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 Criteria1

  • inability to comply with study procedures or unwillingness to participate in the study.

Interventions

OTHERMRI 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.

PROCEDUREProstate 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.

PROCEDURERadical 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.

PROCEDURETURP 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.

PROCEDURERadical 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

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NCT06116851


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