Investigating prostate medication effects on gut microbiota
Prostate Medication, Metabolism and Gut Microbiota
PHASE4 · Turku University Hospital · NCT06001619
This study is testing how prostate medications affect the gut bacteria in men with prostate issues and whether those bacteria influence how well the medications work.
Quick facts
| Phase | PHASE4 |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 18 Years and up |
| Sex | Male |
| Sponsor | Turku University Hospital (other gov) |
| Locations | 2 sites (Turku and 1 other locations) |
| Trial ID | NCT06001619 on ClinicalTrials.gov |
What this trial studies
This study aims to explore the relationship between prostate medications and gut microbiota in men with prostatic hyperplasia and prostate cancer. It will assess how hormonal therapies, such as 5-alpha reductase inhibitors and LHRH antagonists, influence gut microbiota composition and metabolic characteristics. The study will also evaluate how gut microbiota may affect patients' responses to these medications. Participants will receive specific dosages of medications while their gut microbiota and metabolic profiles are monitored over time.
Who should consider this trial
Good fit: Ideal candidates include men diagnosed with prostatic hyperplasia or prostate cancer who are willing to comply with study protocols.
Not a fit: Patients with a history of fecal transplantation or recent gastroenteritis may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to personalized treatment strategies for prostate conditions based on gut microbiota profiles.
How similar studies have performed: While some studies have suggested a link between gut microbiota and therapy responses in prostate cancer, this specific approach is relatively novel and not extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Criteria: * Any history of a fecal transplantation. * Recent (within 3 months or still symptomatic) gastroenteritis. * Antibiotic treatment within 3 months (expect for antibiotic prophylaxis related to prostate biopsies). * Inability to comply with the protocol of unwillingness to participate in the study.
Where this trial is running
Turku and 1 other locations
- Turku University Hospital — Turku, Finland (RECRUITING)
- University of Turku — Turku, Finland (RECRUITING)
Study contacts
- Study coordinator: Peter Bostrom, MD, FEBU
- Email: peter.bostrom@tyks.fi
- Phone: +35823135925
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Prostatic Hyperplasia, Prostate Cancer