Overview
Sponsor-declared trial summary
prostate cancer, benign prostate hyperplasia
The general aim is to understand the interaction of prostate medical therapies and gut microbiota. Main objective is to investigate how prostate medical therapies (5-ARI, ADT) affect gut microbiota composition.
Key facts
- Sponsor
- Turku University Central Hospital
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male
- Therapeutic area
- Diseases [C] - Male Urogenital Diseases [C12]
- Trial duration
- 1 Dec 2022 → ongoing
- Decision date (initial)
- 2022-08-10
- Transition trial
- No
- Low-intervention
- Yes
- Rare-disease indication
- No
- Vulnerable population
- No
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Others
The general aim is to understand the interaction of prostate medical therapies and gut microbiota. Main objective is to investigate how prostate medical therapies (5-ARI, ADT) affect gut microbiota composition.
Secondary objectives 3
- To investigate the mechanism of how hormonal therapies (5-ARI, ADT) affect metabolic changes within the gut and systemic circulation.
- To investigate how the gut microbiota affects a patient’s response to 5-ARI treatment (PSA response and reduction in prostate size) in men with BPH.
- To investigate how the gut microbiota affects a patient’s response to GnRH agonists/antagonists (PSA response) in men with prostate cancer.
Conditions and MedDRA coding
prostate cancer, benign prostate hyperplasia
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 4
- histologically confirmed prostate cancer or benign prostate hyperplasia
- provision of signed and dated informed consent form
- ability and stated willingness to comply with all study procedures and availablity for the duration of the study
- male aged >18 years
Exclusion criteria 2
- inability to comply with study procedures or unwillingness to participate in the study
- age < 18 years
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- change of gut microbiota signature after two months of prostate medication (5-ARI, LhRH-analog/antagonist)
Secondary endpoints 4
- change of gut microbiota metabolism after two months of prostate medication (5-ARI, LhRH-analog/antagonist)
- PSA response to 5-ARI after 2 and 6 months of therapy
- prostate volume change to 5-ARI treatment after 2 and 6 months of therapy
- PSA response LhRH-analog/antagonist after 2 and 6 months of therapy
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 5
SUB06430MIG · Substance
- Active substance
- Dutasteride
- Pharmaceutical form
- CAPSULE, SOFT
- Route of administration
- ORAL
- Max daily dose
- 0.5 mg milligram(s)
- Max total dose
- 0.5 mg milligram(s)
- Max treatment duration
- 6 Month(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB07629MIG · Substance
- Active substance
- Finasteride
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL
- Max daily dose
- 5 mg milligram(s)
- Max total dose
- 5 mg milligram(s)
- Max treatment duration
- 6 Month(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
FIRMAGON 80 mg powder and solvent for solution for injection
PRD3448559 · Product
- Active substance
- Degarelix
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- SUBCUTANEOUS
- Max daily dose
- 80 mg milligram(s)
- Max total dose
- 80 mg milligram(s)
- Max treatment duration
- 6 Month(s)
- Authorisation status
- Authorised
- ATC code
- L02BX02 — -
- Marketing authorisation
- EU/1/08/504/001
- MA holder
- FERRING PHARMACEUTICALS A/S
- MA country
- Liechtenstein
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Duodart 0,5 mg/0,4 mg hårda kapslar
PRD1935327 · Product
- Active substance
- Tamsulosin Hydrochloride
- Pharmaceutical form
- CAPSULE, HARD
- Route of administration
- ORAL
- Max daily dose
- 0.5 mg milligram(s)
- Max total dose
- 0.5 mg milligram(s)
- Max treatment duration
- 6 Month(s)
- Authorisation status
- Authorised
- ATC code
- G04CA52 — -
- Marketing authorisation
- 27116
- MA holder
- GLAXOSMITHKLINE OY
- MA country
- Finland
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
FIRMAGON 120 mg powder and solvent for solution for injection
PRD3448474 · Product
- Active substance
- Degarelix
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- SUBCUTANEOUS USE
- Max daily dose
- 120 mg milligram(s)
- Max total dose
- 120 mg milligram(s)
- Max treatment duration
- 6 Month(s)
- Authorisation status
- Authorised
- ATC code
- L02BX02 — -
- Marketing authorisation
- EU/1/08/504/002
- MA holder
- FERRING PHARMACEUTICALS A/S
- MA country
- Liechtenstein
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Turku University Central Hospital
- Sponsor organisation
- Turku University Central Hospital
- Address
- Kiinamyllynkatu 4-8
- City
- Turku
- Postcode
- 20520
- Country
- Finland
Scientific contact point
- Organisation
- Turku University Central Hospital
- Contact name
- Peter Boström
Public contact point
- Organisation
- Turku University Central Hospital
- Contact name
- Peter Boström
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Finland | Ongoing, recruiting | 100 | 1 |
| Rest of world | — | 0 | — |
Investigational sites
Country notifications
Trial-start, recruitment-start, end and early-termination notifications submitted per Member State
| Country | Trial start | Trial end | Recruitment start | Recruitment end | Early termination |
|---|---|---|---|---|---|
| Finland | 2022-12-01 | 2022-12-01 |
Application history
2 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2022-06-02 | Finland | Acceptable 2022-08-08
|
2022-08-10 |
| 2 | SUBSTANTIAL MODIFICATION | SM-3 | 2022-09-01 | Finland | Acceptable | 2022-10-04 |