Prostate Medication, Metabolism and Gut Microbiota
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexMale
Age18+
SponsorTurku University Hospital
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
Prostate hyperplasia medication
DrugThe dosages prostatic hyperplasia medication: dutasteride 0,5 MG x1 or finasteride 5 MG x1 or combination of dutasteride and tamsulosin 0,5/0,4 MG x1.
LhRH-antagonist
DrugThe starting dose in prostatic cancer patient cohort of LHRH antagonist degarelix is 120 MGx2 and the maintenance dose is 80 MGx1.
Treatment groups
100 Participants
are divided into 2 treatment groupsGroup A: Prostatic hyperplasiaExperimental treatment 1 intervention
Group B: Prostatic cancerExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Gut microbiota signature before 5-ARI therapy
Gut microbiota signature before 5-ARI therapy
Time frame
before starting prostate 5-ARI medication2
Gut microbiota signature after 5-ARI therapy
Gut microbiota signature after 5-ARI therapy
Time frame
2 months after starting prostate 5-ARI medication3
Gut microbiota signature before ADT (LHRH antagonists).
Gut microbiota signature before ADT (LHRH antagonists).
Time frame
before starting prostate degarelix4
Gut microbiota signature after ADT (LHRH antagonists).
Gut microbiota signature after ADT (LHRH antagonists).
Time frame
2 months after starting prostate degarelixSecondary outcomes
1
Metabolic characteristics in the gut and systemic circulation after use of prostate medication
Gut metabolic charachteristics of men receiving prostate medication
Time frame
before starting prostate idcation (degarelix or finasteride/dutasteride)2
Metabolic characteristics in the gut and systemic circulation before iuse of prostate medication
Gut metabolic charachteristics of men receiving prostate medication
Time frame
2 months after from starting prostate medication (degarelix or finasteride/dSponsors and contacts
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Source ClinicalTrials.gov