Actively Recruiting

Age: 18Years +
MALE
ID06116851

Prostate Metabolism, Cancer Risk and Gut Microbiota

Led by Turku University Hospital · Updated on 2023-11-03

300

Participants Needed

2

Research Sites

139 weeks

Total Duration

On this page

Sponsors

T

Turku University Hospital

Lead Sponsor

U

University of Turku

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are investigating the relationship between gut microbiota—the community of microbes in the gastrointestinal tract—and prostate cancer, which is the most common cancer among men in Finland and many western countries. This study aims to confirm earlier findings that suggest differences in gut microbiota may influence prostate cancer risk and to explore metabolic features in the gut, blood, and prostate tissue in men with varied gut bacteria profiles. Participants are grouped into multiple cohorts based on their prostate condition: those with suspicion of prostate cancer undergoing diagnostic tests including MRI and biopsies; men with clinically significant prostate cancer planned for radical prostatectomy; men with benign prostate hyperplasia scheduled for transurethral resection of the prostate (TURP); and men with bladder cancer planned for cystoprostatectomy. Alongside routine clinical procedures, blood, urine, and tissue samples will be collected for study analyses. During the study, participants undergo prostate MRI scans, laboratory visits for blood and urine collection, prostate biopsies if indicated, and surgical procedures when applicable. Researchers will analyze gut microbiota signatures immediately before biopsies and study metabolic markers as secondary measures. The study involves follow-up assessments and tissue sample analyses to better understand connections between gut microbiota and prostate disease. Participation requires compliance with study procedures over the duration of the study.

CONDITIONS

Brief Title

Prostate Metabolism, Cancer Risk and Gut Microbiota

Who Can Participate

Age: 18Years +
MALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Signed and dated informed consent form.
  • Ability and willingness to comply with all study procedures and be available for the study duration.
Not Eligible

You will not qualify if you...

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

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Diagnostic Evaluation

Duration - Up to 4 weeks

Participants undergo prostate cancer diagnostics including MRI scans, laboratory tests, and prostate biopsies as part of routine outpatient care.

1 MRI and laboratory visit and 1 biopsy visit

Treatment

Duration - Based on clinical treatment schedule

Participants diagnosed with prostate conditions may undergo surgery such as radical prostatectomy, TURP, or cystoprostatectomy, with collection of blood, urine, and tissue samples during the procedures.

1 surgical visit (in-person)

Long-term Monitoring

Duration - Ongoing after diagnostic and treatment procedures

Participants are observed over time to study gut microbiota and metabolic characteristics in relation to prostate health.

Additional follow-up visits depending on cohort assignment

Trial Site Locations

Total: 2 locations

1

University of Turku

Turku, Finland, 20100

Actively Recruiting

2

Turku University Hospital

Turku, Finland

Actively Recruiting

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Research Team

P

Peter J. Bostrom, MD, PhD

T

Tarja Lamminen, PhD

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

4

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