Actively Recruiting
Prostate Medication, Metabolism and Gut Microbiota
Led by Turku University Hospital · Updated on 2023-08-21
100
Participants Needed
2
Research Sites
213 weeks
Total Duration
On this page
AI-Summary
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.
CONDITIONS
Official Title
Prostate Medication, Metabolism and Gut Microbiota
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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.
You will not qualify if you...
- Any history of a fecal transplantation.
- Recent (within 3 months or still symptomatic) gastroenteritis.
- Antibiotic treatment within 3 months (except for antibiotic prophylaxis related to prostate biopsies).
- Inability to comply with the protocol or unwillingness to participate in the study.
AI-Screening
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Trial Site Locations
Total: 2 locations
1
Turku University Hospital
Turku, Finland, 20100
Actively Recruiting
2
University of Turku
Turku, Finland, 20100
Actively Recruiting
Research Team
P
Peter Bostrom, MD, FEBU
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
OTHER
Number of Arms
2
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