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Prostate Medication, Metabolism and Gut Microbiota

Prostate Medication, Metabolism and Gut Microbiota

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06001619
Acronym
PROMED
Enrollment
100
Registered
2023-08-21
Start date
2022-12-01
Completion date
2026-12-31
Last updated
2023-08-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prostate Cancer, Prostatic Hyperplasia

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.

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.

Sponsors

Turku University Hospital
Lead SponsorOTHER_GOV

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE

Eligibility

Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Gut microbiota signature before 5-ARI therapybefore starting prostate 5-ARI medicationGut microbiota signature before 5-ARI therapy
Gut microbiota signature after 5-ARI therapy2 months after starting prostate 5-ARI medicationGut microbiota signature after 5-ARI therapy
Gut microbiota signature before ADT (LHRH antagonists).before starting prostate degarelixGut microbiota signature before ADT (LHRH antagonists).
Gut microbiota signature after ADT (LHRH antagonists).2 months after starting prostate degarelixGut microbiota signature after ADT (LHRH antagonists).

Secondary

MeasureTime frameDescription
Metabolic characteristics in the gut and systemic circulation after use of prostate medicationbefore starting prostate idcation (degarelix or finasteride/dutasteride)Gut metabolic charachteristics of men receiving prostate medication
Metabolic characteristics in the gut and systemic circulation before iuse of prostate medication2 months after from starting prostate medication (degarelix or finasteride/dGut metabolic charachteristics of men receiving prostate medication

Countries

Finland

Contacts

Primary ContactPeter Bostrom, MD, FEBU
peter.bostrom@tyks.fi+35823135925

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026