Prostatic HyperplasiaPhase 4PROMEDNCT06001619
Prostate Medication, Metabolism and Gut Microbiota
A Phase 4 study testing Prostate hyperplasia medication and LhRH-antagonist in people with Prostatic Hyperplasia and Prostate Cancer, run by Turku University Hospital at 2 sites in Finland.
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. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostatic Hyperplasia, Prostate Cancer
- What is being tested?
- Prostate hyperplasia medication and LhRH-antagonist
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 2 sitesFinland
- Study dates
- 1 Dec 2022to 31 Dec 2026
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Finland2 sites, 2 recruiting
- Recruiting
Turku University Hospital
Turku, 20100
Peter Bostrom, MD
Peter Bostrom, MD
- Recruiting
University of Turku
Turku, 20100
Peter J Bostrom, MD, PhD, +358-2-3135925, peter.bostrom@tyks.fi
Antti Salminen, MD
About this study
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.
Read the 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.
- Conditions
- Prostatic Hyperplasia, Prostate Cancer
- Being tested
- Prostate hyperplasia medication, LhRH-antagonist
- Medical subject headings
- Prostatic Hyperplasia, Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prostate hyperplasia medicationDrug
Also called Finasteride 5 MG, Dutasteride 0,5 MG, Dutasteride and Tamsulosin 0,5/0,4 MG
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-antagonistDrug
Also called Degarelix 120 MG
The starting dose in prostatic cancer patient cohort of LHRH antagonist degarelix is 120 MGx2 and the maintenance dose is 80 MGx1.
| Study group | Role | What they receive |
|---|---|---|
| Prostatic hyperplasia | Experimental | 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. Receives: Drug: Prostate hyperplasia medication |
| Prostatic cancer | Experimental | 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. Receives: Drug: LhRH-antagonist |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gut microbiota signature before 5-ARI therapy
Gut microbiota signature before 5-ARI therapy
Measured: before starting prostate 5-ARI medication
Gut microbiota signature after 5-ARI therapy
Gut microbiota signature after 5-ARI therapy
Measured: 2 months after starting prostate 5-ARI medication
Gut microbiota signature before ADT (LHRH antagonists).
Gut microbiota signature before ADT (LHRH antagonists).
Measured: before starting prostate degarelix
Gut microbiota signature after ADT (LHRH antagonists).
Gut microbiota signature after ADT (LHRH antagonists).
Measured: 2 months after starting prostate degarelix
Secondary outcomes (2)
Metabolic characteristics in the gut and systemic circulation after use of prostate medication
Gut metabolic charachteristics of men receiving prostate medication
Measured: before starting prostate idcation (degarelix or finasteride/dutasteride)
Metabolic characteristics in the gut and systemic circulation before iuse of prostate medication
Gut metabolic charachteristics of men receiving prostate medication
Measured: 2 months after from starting prostate medication (degarelix or finasteride/d
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2023
- Study start1 Dec 2022
- Primary completion31 Oct 2024 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostatic HyperplasiaStudies of the same condition, open and under way.
- More trials run by Turku University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Turku University Hospital
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06001619
- Sponsor's protocol ID
- 2022-500618-24-00
- Acronym
- PROMED
- Status last verified
- Aug 2023
- First submitted
- 14 Apr 2023
- Last updated
- 21 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prostate Medication, Metabolism and Gut Microbiota
- ClinicalTrials.gov ID
- NCT06001619
- Acronym / sponsor ID
- PROMED / 2022-500618-24-00
- Conditions
- Prostatic Hyperplasia, Prostate Cancer
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Turku University HospitalOther government
- Study start
- 1 Dec 2022 (actual)
- Primary completion
- 31 Oct 2024 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 21 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Prostatic hyperplasia | Experimental | Drug: Prostate hyperplasia medicationInclusion 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. |
| Prostatic cancer | Experimental | Drug: LhRH-antagonistInclusion 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Prostate hyperplasia medicationAlso: Finasteride 5 MG, Dutasteride 0,5 MG, Dutasteride and Tamsulosin 0,5/0,4 MGThe 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. | Drug | Prostatic hyperplasia |
| LhRH-antagonistAlso: Degarelix 120 MGThe starting dose in prostatic cancer patient cohort of LHRH antagonist degarelix is 120 MGx2 and the maintenance dose is 80 MGx1. | Drug | Prostatic cancer |
Primary outcome
Gut microbiota signature before 5-ARI therapy
Time frame: before starting prostate 5-ARI medication
Gut microbiota signature before 5-ARI therapy
Gut microbiota signature after 5-ARI therapy
Time frame: 2 months after starting prostate 5-ARI medication
Gut microbiota signature after 5-ARI therapy
Gut microbiota signature before ADT (LHRH antagonists).
Time frame: before starting prostate degarelix
Gut microbiota signature before ADT (LHRH antagonists).
Gut microbiota signature after ADT (LHRH antagonists).
Time frame: 2 months after starting prostate degarelix
Gut microbiota signature after ADT (LHRH antagonists).
2 secondary outcomes
Metabolic characteristics in the gut and systemic circulation after use of prostate medication
Time frame: before starting prostate idcation (degarelix or finasteride/dutasteride)
Metabolic characteristics in the gut and systemic circulation before iuse of prostate medication
Time frame: 2 months after from starting prostate medication (degarelix or finasteride/d
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Prostate hyperplasia medication and LhRH-antagonist in people with Prostatic Hyperplasia and Prostate Cancer, run by Turku University Hospital at 2 sites in Finland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 21 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Finland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Peter Bostrom, MD, FEBU (+35823135925, peter.bostrom@tyks.fi), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Gut microbiota signature before 5-ARI therapy (time frame: before starting prostate 5-ARI medication). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Aug 2023.