Prostate medication, metabolism and gut microbiota, PROMED.
Phase 1
Recruiting
- Conditions
- Therapeutic area: Diseases [C] - Male Urogenital Diseases [C12]prostate cancer, benign prostate hyperplasia
- Registration Number
- CTIS2022-500618-24-00
- Lead Sponsor
- Turku University Central Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Male
- Target Recruitment
- 100
Inclusion Criteria
histologically confirmed prostate cancer or benign prostate hyperplasia, provision of signed and dated informed consent form, ability and stated willingness to comply with all study procedures and availablity for the duration of the study, male aged >18 years
Exclusion Criteria
inability to comply with study procedures or unwillingness to participate in the study, age < 18 years
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: The general aim is to understand the interaction of prostate medical therapies and gut microbiota. Main objective is to investigate how prostate medical therapies (5-ARI, ADT) affect gut microbiota composition.;Secondary Objective: To investigate the mechanism of how hormonal therapies (5-ARI, ADT) affect metabolic changes within the gut and systemic circulation., To investigate how the gut microbiota affects a patient’s response to 5-ARI treatment (PSA response and reduction in prostate size) in men with BPH., To investigate how the gut microbiota affects a patient’s response to GnRH agonists/antagonists (PSA response) in men with prostate cancer.;Primary end point(s): change of gut microbiota signature after two months of prostate medication (5-ARI, LhRH-analog/antagonist)
- Secondary Outcome Measures
Name Time Method Secondary end point(s):change of gut microbiota metabolism after two months of prostate medication (5-ARI, LhRH-analog/antagonist);Secondary end point(s):PSA response to 5-ARI after 2 and 6 months of therapy;Secondary end point(s):prostate volume change to 5-ARI treatment after 2 and 6 months of therapy;Secondary end point(s):PSA response LhRH-analog/antagonist after 2 and 6 months of therapy