NCT06001619RecruitingPhase 4
Prostate Medication, Metabolism and Gut Microbiota
Source: ClinicalTrials.gov · Last updated 21 Aug 2023 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 100 (estimated)
- First submitted
- 14 Apr 2023
- Start date
- 1 Dec 2022
- Primary completion date
- 31 Oct 2024
- Lead sponsor
- Turku University Hospital
- Diseases
- Prostate cancer
- NCT number
- NCT06001619
What you commit to
- Study type: Interventional · Phase 4
- Planned participants: 100
- From 1 Dec 2022 to the primary completion date, 31 Oct 2024
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Any history of a fecal transplantation.
Other
- 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.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: Male · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University Of Turku Coordinator of this site? Confirm its status | Turku | Finland | Recruiting |
| Turku University Hospital Coordinator of this site? Confirm its status | Turku | Finland | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.