NCT06001619 Prostate Medication, Metabolism and Gut Microbiota
| NCT ID | NCT06001619 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Turku University Hospital |
| Condition | Prostatic Hyperplasia |
| Study Type | INTERVENTIONAL |
| Enrollment | 100 participants |
| Start Date | 2022-12-01 |
| Primary Completion | 2024-10-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 100 participants in total. It began in 2022-12-01 with a primary completion date of 2024-10-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06001619 clinical trial?
This trial is open to male participants only, aged 18 Years or older, studying Prostatic Hyperplasia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06001619 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT06001619 currently recruiting?
Yes, NCT06001619 is actively recruiting participants. Contact the research team at peter.bostrom@tyks.fi for enrollment information.
Where is the NCT06001619 trial being conducted?
This trial is being conducted at Turku, Finland, Turku, Finland.
Who is sponsoring the NCT06001619 clinical trial?
NCT06001619 is sponsored by Turku University Hospital. The trial plans to enroll 100 participants.