To hear about similar clinical trials, please enter your email below
Trial Title:
Prostate Medication, Metabolism and Gut Microbiota
NCT ID:
NCT06001619
Condition:
Prostatic Hyperplasia
Prostate Cancer
Conditions: Official terms:
Prostatic Hyperplasia
Hyperplasia
Tamsulosin
Finasteride
Dutasteride
Study type:
Interventional
Study phase:
Phase 4
Overall status:
Recruiting
Study design:
Allocation:
Non-Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Other
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Prostate hyperplasia medication
Description:
The dosages prostatic hyperplasia medication: dutasteride 0,5 MG x1 or finasteride 5 MG
x1 or combination of dutasteride and tamsulosin 0,5/0,4 MG x1.
Arm group label:
Prostatic hyperplasia
Other name:
Finasteride 5 MG
Other name:
Dutasteride 0,5 MG
Other name:
Dutasteride and Tamsulosin 0,5/0,4 MG
Intervention type:
Drug
Intervention name:
LhRH-antagonist
Description:
The starting dose in prostatic cancer patient cohort of LHRH antagonist degarelix is 120
MGx2 and the maintenance dose is 80 MGx1.
Arm group label:
Prostatic cancer
Other name:
Degarelix 120 MG
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.
Detailed description:
Prostate cancer (PCa) is a significant health care system challenge. PCa is the most
common male cancer in Finland and most western countries. Interestingly, although the
incidence of indolent (latent) PCa is very similar throughout the globe, there is a
remarkable global age-adjusted incidence variation (up to 40-fold difference between
highest and lowest incidences).
Epidemiological data suggest that aging in men is associated with neoplastic processes in
the prostate but only a subset of men will develop a true malignancy potentially
affecting their life-span or quality of life. Genetic factors have a significant effect
on PCa risk, but very likely life-style (e.g. diet and physical activity) affect PCa risk
as well, but the mechanisms mediating protective or harmful effects of life-style remain
unclear.
Gut microbiota, i.e. the collection of microbes colonizing the gastrointestinal tract, is
acknowledged to play significant role in many metabolic pathways and pathogenic processes
in the human body. Although there is some evidence suggesting that gut microbiota affects
therapy responses (especially androgen deprivation) in PCa, it ́s potential role in
prostate carcinogenesis is not well documented. Our previous studies suggest that gut
microbiota composition is different in men with and without PCa and that changes in
steroid hormone synthesis may be one mechanism how gut microbiota affects PCa risk.
Criteria for 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.
Gender:
Male
Gender based:
Yes
Gender description:
Prostatic diseases
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Turku University Hospital
Address:
City:
Turku
Zip:
20100
Country:
Finland
Status:
Recruiting
Contact:
Last name:
Peter Bostrom, MD
Investigator:
Last name:
Peter Bostrom, MD
Email:
Principal Investigator
Facility:
Name:
University of Turku
Address:
City:
Turku
Zip:
20100
Country:
Finland
Status:
Recruiting
Contact:
Last name:
Peter J Bostrom, MD, PhD
Phone:
+358-2-3135925
Email:
peter.bostrom@tyks.fi
Investigator:
Last name:
Antti Salminen, MD
Email:
Sub-Investigator
Start date:
December 1, 2022
Completion date:
December 31, 2026
Lead sponsor:
Agency:
Turku University Hospital
Agency class:
Other
Source:
Turku University Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06001619
