Prostate Medication, Metabolism and Gut Microbiota (PROMED)
Prostatic Hyperplasia, Prostate Cancer
About this trial
This is an interventional other trial for Prostatic Hyperplasia
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.
Sites / Locations
- Turku University HospitalRecruiting
- University of TurkuRecruiting
Arms of the Study
Arm 1
Arm 2
Experimental
Experimental
Prostatic hyperplasia
Prostatic cancer
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.
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.