Clinical trial NCT06001619: Prostate Medication, Metabolism and Gut Microbiota
Official title: Prostate Medication, Metabolism and Gut Microbiota
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Prostatic Hyperplasia
Prostate Cancer
Lead sponsor: Turku University Hospital
Sponsor class: OTHER_GOV
First posted: 2023-08-21
Enrollment: 100
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief 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.

Detailed description: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Gut microbiota signature before 5-ARI therapy
timeFrame: before starting prostate 5-ARI medication
measure: Gut microbiota signature after 5-ARI therapy
timeFrame: 2 months after starting prostate 5-ARI medication
measure: Gut microbiota signature before ADT (LHRH antagonists).
timeFrame: before starting prostate degarelix
measure: Gut microbiota signature after ADT (LHRH antagonists).
timeFrame: 2 months after starting prostate degarelix
Secondary outcomes:
measure: Metabolic characteristics in the gut and systemic circulation after use of prostate medication
timeFrame: before starting prostate idcation (degarelix or finasteride/dutasteride)
measure: Metabolic characteristics in the gut and systemic circulation before iuse of prostate medication
timeFrame: 2 months after from starting prostate medication (degarelix or finasteride/d
Other outcomes:
Locations:
city: Turku
country: Finland
facility: Turku University Hospital
city: Turku
country: Finland
facility: University of Turku
Study officials:
References: