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.
Prostate cancer (PCa) is a significant health care system challenge. PCa is the most common male cancer in Finland and most western countries. Interestingly, although the incidence of indolent (latent) PCa is very similar throughout the globe, there is a remarkable global age-adjusted incidence variation (up to 40-fold difference between highest and lowest incidences). Epidemiological data suggest that aging in men is associated with neoplastic processes in the prostate but only a subset of men will develop a true malignancy potentially affecting their life-span or quality of life. Genetic factors have a significant effect on PCa risk, but very likely life-style (e.g. diet and physical activity) affect PCa risk as well, but the mechanisms mediating protective or harmful effects of life-style remain unclear. Gut microbiota, i.e. the collection of microbes colonizing the gastrointestinal tract, is acknowledged to play significant role in many metabolic pathways and pathogenic processes in the human body. Although there is some evidence suggesting that gut microbiota affects therapy responses (especially androgen deprivation) in PCa, it ́s potential role in prostate carcinogenesis is not well documented. Our previous studies suggest that gut microbiota composition is different in men with and without PCa and that changes in steroid hormone synthesis may be one mechanism how gut microbiota affects PCa risk.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
OTHER
Masking
NONE
Enrollment
100
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.
The starting dose in prostatic cancer patient cohort of LHRH antagonist degarelix is 120 MGx2 and the maintenance dose is 80 MGx1.
Turku University Hospital
Turku, Finland
RECRUITINGUniversity of Turku
Turku, Finland
RECRUITINGGut microbiota signature before 5-ARI therapy
Gut microbiota signature before 5-ARI therapy
Time frame: before starting prostate 5-ARI medication
Gut microbiota signature after 5-ARI therapy
Gut microbiota signature after 5-ARI therapy
Time frame: 2 months after starting prostate 5-ARI medication
Gut microbiota signature before ADT (LHRH antagonists).
Gut microbiota signature before ADT (LHRH antagonists).
Time frame: before starting prostate degarelix
Gut microbiota signature after ADT (LHRH antagonists).
Gut microbiota signature after ADT (LHRH antagonists).
Time frame: 2 months after starting prostate degarelix
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)
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/d
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