Prostate Medication, Metabolism and Gut Microbiota

Prostate Cancer Clinical Trial

— PROMED  

Official title:

Prostate Medication, Metabolism and Gut Microbiota

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06001619
• Other study ID #: 2022-500618-24-00
• Status: Recruiting
• Phase: Phase 4
• Start date: December 1, 2022
• Est. completion date: December 31, 2026

Study information

• Verified date: August 2023
• Source: Turku University Hospital
• Contact: Peter Bostrom, MD, FEBU
• Phone: +35823135925
• Email: peter.bostrom[@]tyks.fi
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 31, 2026
• Est. primary completion date: October 31, 2024
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Hyperplasia
• Prostate Cancer
• Prostatic Hyperplasia

Intervention

Drug:
• Prostate hyperplasia medication
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.
• LhRH-antagonist
The starting dose in prostatic cancer patient cohort of LHRH antagonist degarelix is 120 MGx2 and the maintenance dose is 80 MGx1.

Locations

Country	Name	City	State
Finland	Turku University Hospital	Turku
Finland	University of Turku	Turku

Sponsors (1)

Lead Sponsor	Collaborator
Turku University Hospital

Country where clinical trial is conducted

Finland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Gut microbiota signature before 5-ARI therapy	Gut microbiota signature before 5-ARI therapy	before starting prostate 5-ARI medication
Primary	Gut microbiota signature after 5-ARI therapy	Gut microbiota signature after 5-ARI therapy	2 months after starting prostate 5-ARI medication
Primary	Gut microbiota signature before ADT (LHRH antagonists).	Gut microbiota signature before ADT (LHRH antagonists).	before starting prostate degarelix
Primary	Gut microbiota signature after ADT (LHRH antagonists).	Gut microbiota signature after ADT (LHRH antagonists).	2 months after starting prostate degarelix
Secondary	Metabolic characteristics in the gut and systemic circulation after use of prostate medication	Gut metabolic charachteristics of men receiving prostate medication	before starting prostate idcation (degarelix or finasteride/dutasteride)
Secondary	Metabolic characteristics in the gut and systemic circulation before iuse of prostate medication	Gut metabolic charachteristics of men receiving prostate medication	2 months after from starting prostate medication (degarelix or finasteride/d