RecruitingPhase 4NCT06001619

Prostate Medication, Metabolism and Gut Microbiota


Sponsor

Turku University Hospital

Enrollment

100 participants

Start Date

Dec 1, 2022

Study Type

INTERVENTIONAL

Conditions

Summary

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

Sex: MALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study investigates how medications used to treat prostate conditions affect gut bacteria (the microbiome) and metabolism in men undergoing treatment, aiming to understand the relationship between prostate drugs and digestive health. **You may be eligible if...** - You are being treated for a prostate condition and are willing to participate in study procedures over the study period - You are able and willing to comply with all study requirements - You have signed and dated the informed consent form **You may NOT be eligible if...** - You have had a fecal microbiota transplant at any time - You had gastroenteritis (a stomach bug) within the past 3 months or still have symptoms - You have taken antibiotics within the past 3 months (unless it was just for a prostate biopsy procedure) - You are unwilling or unable to comply with the study protocol Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGProstate hyperplasia medication

The 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.

DRUGLhRH-antagonist

The starting dose in prostatic cancer patient cohort of LHRH antagonist degarelix is 120 MGx2 and the maintenance dose is 80 MGx1.


Locations(2)

Turku University Hospital

Turku, Finland

University of Turku

Turku, Finland

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NCT06001619


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