Clinical trial • Phase III • Oncology|Other
ATORVASTATIN for Metastatic prostate cancer|High-risk recurrent prostate cancer
Phase III trial of ATORVASTATIN for Metastatic prostate cancer|High-risk recurrent prostate cancer.
Overview
- Trial Therapeutic Area
- Oncology|Other
- Trial Disease
- Metastatic prostate cancer|High-risk recurrent prostate cancer
- Trial Stage
- Phase III
- Drug Modality
- Small molecule
Key dates
- Initial CTIS Submission Date
- 13-09-2024
- First CTIS Authorization Date
- 15-10-2024
Trial design
Randomised, placebo: 'identical capsule as the active product but without any active ingredient.'; active: atorvastatin krka 40 mg (oral, over-encapsulated). dosing schedule not specified in record.-controlled Phase III trial across 12 sites in Finland, Denmark, Norway and others.
- Randomised
- Yes
- Comparator
- Placebo: 'Identical capsule as the active product but without any active ingredient.'; Active: Atorvastatin Krka 40 mg (oral, over-encapsulated). Dosing schedule not specified in record.
- Target Sample Size
- 400
Eligibility
Recruits 400 No vulnerable population selected; participants are adult males. Consent requirement: 'Willingness to participate and signing of informed consent'. Subject information and informed consent forms available in multiple languages (Finnish, Swedish, Russian, Danish, Norwegian, Estonian)..
- Vulnerable Population
- No vulnerable population selected; participants are adult males. Consent requirement: 'Willingness to participate and signing of informed consent'. Subject information and informed consent forms available in multiple languages (Finnish, Swedish, Russian, Danish, Norwegian, Estonian).
Inclusion criteria
- {"criterion_text":"- Histopathologically confirmed metastatic adenocarcinoma of the prostate (radiologically confirmed bone or soft tissue metastasis or enlarged lymph nodes at minimum 15 mm in diameter beyond the pelvic lymph nodes) for which androgen deprivation or antiandrogen therapy (GnRH agonist/antagonist, bicalutamide/flutamide, surgical castration or enzalutamide/abiraterone monotherapy) is initiated no longer than 3 months before either as the primary treatment\n- High-risk M0 stage prostate cancer recurring after curative-intent primary therapy (surgery or radiotherapy) for which androgen deprivation or antiandrogen therapy (GnRH agonist/antagonist, bicalutamide/flutamide, surgical castration or enzalutamide/abiraterone monotherapy) is initiated no longer than 3 months before recruitment. •\tHigh risk M0 prostate cancer defined when one of the following criteria fulfilled: o\tPrimarily Gleason 8-10 cancer OR o\tPSA doubling time ≤ 6 months OR o\tPSA ≥ 20 ng/ml OR o\tnew lymph node metastases in imaging o\tprevious prostatectomy and radiation therapy allowed o\tADT/antiandrogen therapy for neoadjuvant hormone therapy is not included\n- Willingness to participate and signing of informed consent"}
Exclusion criteria
- {"criterion_text":"- Statin use at the time of recruitment or within 6 months of it\n- Previous adverse effects during statin therapy\n- Familial hypercholesterolemia or very high total cholesterol (9.3 mmol/l or above)\n- Clinically significant renal insufficiency (serum creatinine above 170 µmol/l) or liver insufficiency (serum alanine aminotransferase more than 2x above the upper limit of normal range)\n- Use of drugs that may interact with statins (St John’s Wort, HIV protease inhibitors, ciclosporin, macrolide antibiotics, fucidic acid, phenytoin, carbamazepine, dronedarone or oral antifungal medication)\n- Hypersensitivity to the active substance (atorvastatin) or to any of the excipients in the atorvastatin product (microcrystalline cellulose, sodium carbonate, maltose, croscarmellose sodium, magnesium stearate, hypromellose (E464), hydroxypropylcellulose, triethyl citrate (E1505), polysorbate 80 or titanium dioxide (E171))"}
Endpoints
Primary endpoints
- {"endpoint_text":"- Time to disease progression after starting ADT/antiandrogen therapy","definition_or_measurement_approach":""}
Recruitment
- Planned Sample Size
- 400
- Recruitment Window Months
- 187
- Consent Approach
- Informed consent is required: 'Willingness to participate and signing of informed consent'. Subject information and consent forms provided in multiple languages (Finnish, Swedish, Russian, Danish, Norwegian, Estonian). Consent provided by the participant (adult males); no assent procedures described.
Geography
- Total Number Of Sites
- 12
- Total Number Of Participants
- 400
Finland
- Earliest CTIS Part Ii Submission Date
- 30-09-2024
- Latest Decision Or Authorization Date
- 15-10-2024
- Processing Time Days
- 15
- Number Of Sites
- 5
- Number Of Participants
- 250
Sites
- Site Name
- Tampere University Hospital
- Department Name
- Department of Urology
- Principal Investigator Name
- Teemu Murtola
- Principal Investigator Email
- teemu.murtola@pirha.fi
- Contact Person Name
- Teemu Murtola
- Contact Person Email
- teemu.murtola@pirha.fi
- Site Name
- Central Finland Hospital District Central Finland Hospital Nova
- Department Name
- Department of Urology
- Principal Investigator Name
- Lasse Hirvonen
- Principal Investigator Email
- lasse.hirvonen@hyvaks.fi
- Contact Person Name
- Lasse Hirvonen
- Contact Person Email
- lasse.hirvonen@hyvaks.fi
- Site Name
- Etelae-Pohjanmaan hyvinvointialue
- Department Name
- Department of Urology
- Principal Investigator Name
- Timo Marttila
- Principal Investigator Email
- timo.marttila@hyvaep.fi
- Contact Person Name
- Timo Marttila
- Contact Person Email
- timo.marttila@hyvaep.fi
- Site Name
- Turku University Hospital
- Department Name
- Department of Urology
- Principal Investigator Name
- Otto Ettala
- Principal Investigator Email
- otto.ettala@varha.fi
- Contact Person Name
- Otto Ettala
- Contact Person Email
- otto.ettala@varha.fi
- Site Name
- HUS-Yhtymae
- Department Name
- Department of Urology
- Principal Investigator Name
- Antti Rannikko
- Principal Investigator Email
- antti.rannikko@hus.fi
- Contact Person Name
- Antti Rannikko
- Contact Person Email
- antti.rannikko@hus.fi
Denmark
- Earliest CTIS Part Ii Submission Date
- 30-09-2024
- Latest Decision Or Authorization Date
- 21-10-2024
- Processing Time Days
- 21
- Number Of Sites
- 4
- Number Of Participants
- 80
Sites
- Site Name
- Aarhus Universitetshospital
- Department Name
- Department of urology
- Principal Investigator Name
- Michael Borre
- Principal Investigator Email
- borre@clin.au.dk
- Contact Person Name
- Michael Borre
- Contact Person Email
- borre@clin.au.dk
- Site Name
- Odense University Hospital
- Department Name
- Urology
- Principal Investigator Name
- Grzegorz Fojecki
- Principal Investigator Email
- glf@rsyd.dk
- Contact Person Name
- Grzegorz Fojecki
- Contact Person Email
- glf@rsyd.dk
- Site Name
- Region Hovedstaden
- Department Name
- Department of Urology
- Principal Investigator Name
- Peter Østergreen
- Principal Investigator Email
- peter.busch.oestergren@regionh.dk
- Contact Person Name
- Peter Østergreen
- Contact Person Email
- peter.busch.oestergren@regionh.dk
- Site Name
- Rigshospitalet
- Department Name
- Department of urology
- Principal Investigator Name
- Andreas Røder
- Principal Investigator Email
- andreas.roeder@regionh.dk
- Contact Person Name
- Andreas Røder
- Contact Person Email
- andreas.roeder@regionh.dk
Norway
- Earliest CTIS Part Ii Submission Date
- 30-09-2024
- Latest Decision Or Authorization Date
- 07-11-2024
- Processing Time Days
- 38
- Number Of Sites
- 2
- Number Of Participants
- 50
Sites
- Site Name
- Sykehuset I Vestfold HF
- Department Name
- Urologiska department
- Principal Investigator Name
- Sven Löffeler
- Principal Investigator Email
- sven.loffeler@siv.no
- Contact Person Name
- Sven Löffeler
- Contact Person Email
- sven.loffeler@siv.no
- Site Name
- Sykehuset Telemark HF
- Department Name
- Department of Surgery/Section of Urology
- Principal Investigator Name
- Rasmus Nilsson
- Principal Investigator Email
- rasmus.nilsson@sthf.no
- Contact Person Name
- Rasmus Nilsson
- Contact Person Email
- rasmus.nilsson@sthf.no
Estonia
- Earliest CTIS Part Ii Submission Date
- 30-09-2024
- Latest Decision Or Authorization Date
- 21-10-2024
- Processing Time Days
- 21
- Number Of Sites
- 1
- Number Of Participants
- 20
Sites
- Site Name
- Tartu University Hospital
- Department Name
- Department of urology
- Principal Investigator Name
- Andres Kotsar
- Principal Investigator Email
- andres.kotsar@kliinikum.ee
- Contact Person Name
- Andres Kotsar
- Contact Person Email
- andres.kotsar@kliinikum.ee
Sponsor
Primary sponsor
- Full Name
- Pirkanmaan hyvinvointialue
- Organisation Type
- Hospital/Clinic/Other health care facility
- Country Of Registered Address
- Finland
Third parties
- {"country":"Denmark","full_name":"Frederiksberg Hospital","duties_or_roles":"code:1","organisation_type":"Hospital/Clinic/Other health care facility"}
Investigational products
- Investigational Product Name
- Atorvastatin Krka 40 mg kalvopäällysteiset tabletit
- Active Substance
- ATORVASTATIN
- Modality
- Small molecule
- Routes Of Administration
- ORAL USE
- Route
- Oral
- Authorisation Status
- Authorised (marketing authorisation present)
- Starting Dose
- 40 mg
- Maximum Dose
- 80 mg (max daily dose amount 80 mg)
- Investigational Product Name
- Identical capsule as the active product but without any active ingredient.
- Modality
- Other
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