Prostate Medication, Metabolism and Gut Microbiota

NCT06001619 | Recruiting Phase 4

• 1 other identifier: 2022-500618-24-00
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 2

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.

Conditions

Prostatic Hyperplasia; Prostate Cancer

Outcome Measures

Primary Outcomes (4)

• Gut microbiota signature before 5-ARI therapy

  Gut microbiota signature before 5-ARI therapy

  before starting prostate 5-ARI medication

• Gut microbiota signature after 5-ARI therapy

  Gut microbiota signature after 5-ARI therapy

  2 months after starting prostate 5-ARI medication

• Gut microbiota signature before ADT (LHRH antagonists).

  Gut microbiota signature before ADT (LHRH antagonists).

  before starting prostate degarelix

• Gut microbiota signature after ADT (LHRH antagonists).

  Gut microbiota signature after ADT (LHRH antagonists).

  2 months after starting prostate degarelix

Secondary Outcomes (2)

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

  before starting prostate idcation (degarelix or finasteride/dutasteride)

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

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

Study Arms (2)

Prostatic hyperplasia

EXPERIMENTAL

Inclusion criteria for the BPH cohort includes clinical decision to initiate treatment of benign prostate hyperplasia (BPH) with 5-alpha-reductase inhibitors (finasteride, dutasteride, or combination of dutasteride and tamsulosin). Before starting the medication, size of the prostate has been measured with TRUS (transrectal ultrasound). The BPH cohort will include a total of 50 subjects and the study samples (gut microbiota, metabolite sampling) will be collected prior the start of the 5-alpha- reductase inhibitors and after 2 months of medical therapy. At this stage, PSA is determined from blood sample and the size of the prostate is measured with transrectal ultrasound (TRUS). In addition, after 6 months, PSA and prostate size measurements are repeated.

Drug: Prostate hyperplasia medication

Prostatic cancer

EXPERIMENTAL

Inclusion criteria for the cancer cohort include a clinical decision to initiate PCa treatment with androgen deprivation therapy (ADT) with LHRH antagonist (degarelix). This may include either treatment of a metastatic disease with definite ADT or adjuvant ADT to external beam radiation of the prostate. The cancer cohort will include a total of 50 subjects and the study samples (gut microbiota, metabolite sampling) will be collected prior the start of the ADT and after 2 months of medical therapy. In addition, after 2 and 6 months, PSA measurement is repeated.

Drug: LhRH-antagonist

Interventions

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.

Also known as: Finasteride 5 MG, Dutasteride 0,5 MG, Dutasteride and Tamsulosin 0,5/0,4 MG

Prostatic hyperplasia

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.

Also known as: Degarelix 120 MG

Prostatic cancer

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Prostatic diseases
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Turku University Hospital: lead

Study Sites (2)

Turku University Hospital

Turku, 20100, Finland

RECRUITING

University of Turku

Turku, 20100, Finland

RECRUITING

MeSH Terms

Conditions

Prostatic Hyperplasia; Prostatic Neoplasms

Interventions

Finasteride; Dutasteride; acetyl-2-naphthylalanyl-3-chlorophenylalanyl-1-oxohexadecyl-seryl-4-aminophenylalanyl(hydroorotyl)-4-aminophenylalanyl(carbamoyl)-leucyl-ILys-prolyl-alaninamide

Condition Hierarchy (Ancestors)

Prostatic Diseases; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Male Urogenital Diseases; Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms

Intervention Hierarchy (Ancestors)

Androstenes; Androstanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Azasteroids; Steroids, Heterocyclic

Central Study Contacts

Peter Bostrom, MD, FEBU

CONTACT

+35823135925; peter.bostrom@tyks.fi

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 14, 2023
• First Posted: August 21, 2023
• Study Start: December 1, 2022
• Primary Completion: October 31, 2024
• Study Completion (Estimated): December 31, 2026
• Last Updated: August 21, 2023

Record last verified: 2023-08

Locations

FI (2)