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NCT Number: NCT06001619

Prostate Medication, Metabolism and Gut Microbiota

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.

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Key information

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Phase 4

Primary location

Turku University Hospital, Turku, Finland

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Prostate hyperplasia medication

Drug

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.

Other names: Finasteride 5 MG, Dutasteride 0,5 MG, Dutasteride and Tamsulosin 0,5/0,4 MG

LhRH-antagonist

Drug

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

Other names: Degarelix 120 MG

Primary outcomes

  1. Gut microbiota signature before 5-ARI therapy

    Time frame: before starting prostate 5-ARI medication

    Gut microbiota signature before 5-ARI therapy

  2. Gut microbiota signature after 5-ARI therapy

    Time frame: 2 months after starting prostate 5-ARI medication

    Gut microbiota signature after 5-ARI therapy

  3. Gut microbiota signature before ADT (LHRH antagonists).

    Time frame: before starting prostate degarelix

    Gut microbiota signature before ADT (LHRH antagonists).

  4. Gut microbiota signature after ADT (LHRH antagonists).

    Time frame: 2 months after starting prostate degarelix

    Gut microbiota signature after ADT (LHRH antagonists).

Secondary outcomes

  1. Metabolic characteristics in the gut and systemic circulation after use of prostate medication

    Time frame: before starting prostate idcation (degarelix or finasteride/dutasteride)

    Gut metabolic charachteristics of men receiving prostate medication

  2. Metabolic characteristics in the gut and systemic circulation before iuse of prostate medication

    Time frame: 2 months after from starting prostate medication (degarelix or finasteride/d

    Gut metabolic charachteristics of men receiving prostate medication

Study contacts

Contact information is provided by the study sponsor or research team.

Peter Bostrom, MD, FEBU

CONTACT

[email protected]

+35823135925

Sponsors and collaborators

Lead sponsor

Turku University Hospital

Other Gov

Registry information

Acronym: PROMED

Important dates

Study start
2022
Primary completion
2024
Study completion
2026
First posted
Aug 21, 2023
Registry last updated
Aug 21, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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