Clinical trial · Interventional
Prostate Medication, Metabolism and Gut Microbiota
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
| Prostatic Hyperplasia | Benign Prostatic Hyperplasia | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| LhRH-antagonist | Drug | — | UNRESOLVED |
| Prostate hyperplasia medication | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Prostatic hyperplasia
- description
- 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.
- interventionNames
- Drug: Prostate hyperplasia medication
- type
- EXPERIMENTAL
- label
- Prostatic cancer
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available