Prostate Medication, Metabolism and Gut Microbiota

Short name PROMED

NCTNCT06001619Other id2022-500618-24-00

Open at ClinicalTrials.govAsk about this trial

Overview

Status: Recruiting
Phase: Phase 4
Enrollment: 100 participants (estimated)
Sponsor: Turku University Hospital · Other gov
Design: Not randomized · Open label (no masking)
Countries: 1 country
Finland
Start: 1 Dec 2022
Primary completion: 31 Oct 2024 (estimated)
Completion: 31 Dec 2026 (estimated)
First posted: 21 Aug 2023
Last update posted: 21 Aug 2023
Conditions: Prostatic Hyperplasia · Prostate Cancer

Timeline

1 trial · 1 ongoing

Completed
Ongoing
Not yet recruiting
Stopped
Estimated dates (est.)
Results posted

202220232024202520262027

Ph 4
PROMED
NCT06001619
1 Dec 2022 to est. 31 Dec 2026

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

Prostate hyperplasia medicationDrug
LhRH-antagonistDrug

Arms2

Experimental
Prostatic hyperplasia
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.
Experimental
Prostatic cancer
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.

Primary outcomes4

Outcomes the sponsor listed as primary.

Gut microbiota signature before 5-ARI therapy
Time frame · before starting prostate 5-ARI medication
Registry description
Gut microbiota signature before 5-ARI therapy
Gut microbiota signature after 5-ARI therapy
Time frame · 2 months after starting prostate 5-ARI medication
Registry description
Gut microbiota signature after 5-ARI therapy
Gut microbiota signature before ADT (LHRH antagonists).
Time frame · before starting prostate degarelix
Registry description
Gut microbiota signature before ADT (LHRH antagonists).
Gut microbiota signature after ADT (LHRH antagonists).
Time frame · 2 months after starting prostate degarelix
Registry description
Gut microbiota signature after ADT (LHRH antagonists).

Secondary outcomes(2)

Metabolic characteristics in the gut and systemic circulation after use of prostate medication
Time frame · before starting prostate idcation (degarelix or finasteride/dutasteride)
Registry description
Gut metabolic charachteristics of men receiving prostate medication
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
Registry description
Gut metabolic charachteristics of men receiving prostate medication

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

A trial that is still running, or that stopped early, may post results later.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex: Male
Age: from 18 Years
Healthy volunteers: Not accepted

Inclusion and exclusion criteria, as posted

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.

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