Prostate Medication, Metabolism and Gut Microbiota
Recruiting · NCT06001619 · Interventional (participants receive a specific treatment) · Lead sponsor: Turku University Hospital
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
PROMED is a prospective, single center translational multiple cohort study to investigate the association of prostate medication and gut microbiota. The main aim is to investigate how prostate hormonal therapy (5-ARI, ADT) affects gut microbiota composition. Aalso study metabolic characteristics in the gut and systemic circulation in men with different medications will be studied. In addition, the effect of gut microbiota on patient's response to medications will be investigated. The medicines used in the study to treat benign prostate hyperplasia are dutasteride and finasteride and a combination of dutasteride and tamsulosin. LHRH antagonist degarelix is used as a medication to treat patients with cancer. The dosages of 5-ARI medication: dutasteride 0,5mg x1 or finasteride 5mg x1 or combination of dutasteride and tamsulosin 0,5/0,4mg x1. The starting dose of LHRH antagonist degarelix is 120mgx2 and the maintenance dose is 80mgx1. The medication for PCa is planned according to the protocol but so that each subject receives degarelix at the beginning of treatment and one month after initiation. Thereafter, the medication is continued according to the clinician's assessment. The study is carried out in Turku University Hospital and University of Turku.
Who can take part
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 it is running
2 locations listed.
- Turku University Hospital - Turku, Finland
- University of Turku - Turku, Finland