search
Back to results

Prostate Medication, Metabolism and Gut Microbiota (PROMED)

Primary Purpose

Prostatic Hyperplasia, Prostate Cancer

Status
Recruiting
Phase
Phase 4
Locations
Finland
Study Type
Interventional
Intervention
Prostate hyperplasia medication
LhRH-antagonist
Sponsored by
Turku University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Prostatic Hyperplasia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

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

Arm Type

Experimental

Experimental

Arm Label

Prostatic hyperplasia

Prostatic cancer

Arm 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.

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.

Outcomes

Primary Outcome Measures

Gut microbiota signature before 5-ARI therapy
Gut microbiota signature before 5-ARI therapy
Gut microbiota signature after 5-ARI therapy
Gut microbiota signature after 5-ARI therapy
Gut microbiota signature before ADT (LHRH antagonists).
Gut microbiota signature before ADT (LHRH antagonists).
Gut microbiota signature after ADT (LHRH antagonists).
Gut microbiota signature after ADT (LHRH antagonists).

Secondary Outcome Measures

Metabolic characteristics in the gut and systemic circulation after use of prostate medication
Gut metabolic charachteristics of men receiving prostate medication
Metabolic characteristics in the gut and systemic circulation before iuse of prostate medication
Gut metabolic charachteristics of men receiving prostate medication

Full Information

First Posted
April 14, 2023
Last Updated
August 17, 2023
Sponsor
Turku University Hospital
search

1. Study Identification

Unique Protocol Identification Number
NCT06001619
Brief Title
Prostate Medication, Metabolism and Gut Microbiota
Acronym
PROMED
Official Title
Prostate Medication, Metabolism and Gut Microbiota
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
December 1, 2022 (Actual)
Primary Completion Date
October 31, 2024 (Anticipated)
Study Completion Date
December 31, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Turku University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostatic Hyperplasia, Prostate Cancer

7. Study Design

Primary Purpose
Other
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Prostatic hyperplasia
Arm Type
Experimental
Arm 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.
Arm Title
Prostatic cancer
Arm Type
Experimental
Arm 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.
Intervention Type
Drug
Intervention Name(s)
Prostate hyperplasia medication
Other Intervention Name(s)
Finasteride 5 MG, Dutasteride 0,5 MG, Dutasteride and Tamsulosin 0,5/0,4 MG
Intervention 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.
Intervention Type
Drug
Intervention Name(s)
LhRH-antagonist
Other Intervention Name(s)
Degarelix 120 MG
Intervention Description
The starting dose in prostatic cancer patient cohort of LHRH antagonist degarelix is 120 MGx2 and the maintenance dose is 80 MGx1.
Primary Outcome Measure Information:
Title
Gut microbiota signature before 5-ARI therapy
Description
Gut microbiota signature before 5-ARI therapy
Time Frame
before starting prostate 5-ARI medication
Title
Gut microbiota signature after 5-ARI therapy
Description
Gut microbiota signature after 5-ARI therapy
Time Frame
2 months after starting prostate 5-ARI medication
Title
Gut microbiota signature before ADT (LHRH antagonists).
Description
Gut microbiota signature before ADT (LHRH antagonists).
Time Frame
before starting prostate degarelix
Title
Gut microbiota signature after ADT (LHRH antagonists).
Description
Gut microbiota signature after ADT (LHRH antagonists).
Time Frame
2 months after starting prostate degarelix
Secondary Outcome Measure Information:
Title
Metabolic characteristics in the gut and systemic circulation after use of prostate medication
Description
Gut metabolic charachteristics of men receiving prostate medication
Time Frame
before starting prostate idcation (degarelix or finasteride/dutasteride)
Title
Metabolic characteristics in the gut and systemic circulation before iuse of prostate medication
Description
Gut metabolic charachteristics of men receiving prostate medication
Time Frame
2 months after from starting prostate medication (degarelix or finasteride/d

10. Eligibility

Sex
Male
Gender Based
Yes
Gender Eligibility Description
Prostatic diseases
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Peter Bostrom, MD, FEBU
Phone
+35823135925
Email
peter.bostrom@tyks.fi
Facility Information:
Facility Name
Turku University Hospital
City
Turku
ZIP/Postal Code
20100
Country
Finland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Peter Bostrom, MD
First Name & Middle Initial & Last Name & Degree
Peter Bostrom, MD
Facility Name
University of Turku
City
Turku
ZIP/Postal Code
20100
Country
Finland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Peter J Bostrom, MD, PhD
Phone
+358-2-3135925
Email
peter.bostrom@tyks.fi
First Name & Middle Initial & Last Name & Degree
Antti Salminen, MD

12. IPD Sharing Statement

Learn more about this trial

Prostate Medication, Metabolism and Gut Microbiota

We'll reach out to this number within 24 hrs