Metastatic Prostate CancerPhase 3ESTO2NCT04026230
Impact of Atorvastatin on Prostate Cancer Progression During ADT
A Phase 3 study testing Atorvastatin 80mg in people with Metastatic Prostate Cancer and Recurrent Prostate Cancer, run by Tampere University Hospital at 10 sites in 4 countries.
Trial summary
This randomized double-blind placebo-controlled trial tests whether intervention with atorvastatin delays development of castration resistance compared to placebo during androgen deprivation therapy (ADT) for prostate cancer. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Metastatic Prostate Cancer, Recurrent Prostate Cancer
- What is being tested?
- Atorvastatin 80mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 400 participants
- Where
- 10 sitesin 4 countries
- Study dates
- 15 Aug 2019to 31 Dec 2025
- Phase
- Phase 3
- Are there results?
- None posted in the registry
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
- Histopathologically confirmed metastatic (radiologically confirmed bone or soft tissue metastasis or enlarged lymph nodes at minimum 15 mm in diameter beyond the pelvic lymph nodes) or recurrent (requiring treatment after curative-intent surgery or radiotherapy) adenocarcinoma of the prostate for which androgen deprivation or antiandrogen therapy (GnRH agonist/antagonist, bicalutamide/flutamide, surgical castration or enzalutamide/abiraterone monotherapy) is initiated as definitive treatment no longer than 3 months before recruitment
- previous prostatectomy and radiation therapy allowed
- ADT/antiandrogen therapy for neoadjuvant hormone therapy is not included
- Willingness to participate and signing of informed consent
Who cannot join
- Statin use at the time of recruitment or within 6 months of it
- Previous adverse effects during statin therapy
- Familial hypercholesterolemia or very high total cholesterol (9.3 mmol/l or above)
- 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)
- 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).
Trial locations and contacts
10 sites in 4 countries.
Aino Siltari, PhD contact
10 sites in 4 countries
Finland6 sites, 6 recruiting
- Recruiting
Helsinki University Hospital, Department of Urology
Helsinki
Antti Rannikko, MD,PhD, antti.rannikko@hus.fi
- Recruiting
Central Finland central hospital
Jyväskylä
Heikki Seikkula, MD, PhD, heikki.seikkula@ksshp.fi
- Not yet recruiting
Kuopio University Hospital, Department of Urology
Kuopio
Arto Salonen, MD,PhD, arto.salonen@kuh.fi
- Recruiting
Seinäjoki Central Hospital, Department of Surgery
Seinäjoki
Timo Marttila, MD,PhD, timo.marttila@epshp.fi
- Recruiting
Tampere University Hospital
Tampere
Teemu Murtola, MD, PhD, teemu.murtola@tuni.fi
- Recruiting
Turku University Hospital
Turku
Otto Ettala, MD, PhD, otto.ettala@utu.fi
Norway2 sites, 2 recruiting
- Recruiting
The Hospital of Telemark
Skien
Rasmus Nilsson, MD, PhD, Rasmus.Nilsson@sthf.no
- Recruiting
The Hospital of Vestfold
Tønsberg
Sven Lofferen, MD, PhD, sven.loffeler@siv.no
Denmark1 site, 1 recruiting
- Not yet recruiting
Herlev and Gentofte Hospital
Herlev
Mikkel Fode, MD, PhD, mikkelfode@gmail.com
Peter Oestergren, MD, PhD, peter.busch.oestergren@regionh.dk
Estonia1 site, 1 recruiting
- Recruiting
Tartu University Hospital
Tartu
Andres Kotsar, MD, PhD, andres.kotsar@gmail.com
About this study
Official title: Impact of Atorvastatin on Prostate Cancer Progression After Initiation of Androgen Deprivation Therapy - Lipid Metabolism as a Novel Biomarker to Predict Prostate Cancer Progression
This randomized double-blind placebo-controlled trial tests whether intervention with atorvastatin delays development of castration resistance compared to placebo during androgen deprivation therapy (ADT) for prostate cancer.
Read the detailed description
Cholesterol-lowering statin drugs have been reported to lower proliferation activity in prostate cancer, delay occurrence of castration resistance and reduce the risk of prostate cancer death. Therefore, it is important to test statins' efficacy in addition to conventional prostate cancer treatment in a randomized, placebo-controlled trial.
This phase 3 randomized double-blind placebo-controlled trial will explore whether intervention with atorvastatin delays prostate cancer progression i.e. development of castration resistance compared to placebo during androgen deprivation therapy (ADT) for metastatic or recurrent prostate cancer.
Secondary objectives include exploring whether atorvastatin lowers prostate cancer-specific or overall mortality compared to placebo, and to demonstrate whether changes in serum lipid parameters predict disease recurrence and occurrence of adverse genomic changes predicting castration resistance among prostate cancer patients during ADT.
The study recruitment target is 400 participants who start ADT as management of metastatic or recurrent prostate cancer. These men will be randomized 1:1 (200 + 200) to receive blinded study drug, either 80 mg of atorvastatin daily or placebo until disease recurrence i.e. development of castration resistance or for a maximum of five years.
The study will be carried out in collaboration between urological departments of University Hospitals in Finland as a project of the national FinnProstata study group, Herlev University Hospital in Denmark, Vestfold and Telemark hospitals in Norway and the Tartu University Hospital in Estonia.
Follow-up is continued until the primary end-point, development of castration resistance. After this the participants will be given the opportunity to voluntarily carry on with the blinded intervention for maximum time of ten year to observe effects on survival after development of castration resistance. Blinding will be lifted after the follow-up is complete for all study participants.
Castration resistance is defined as prostate-specific antigen (PSA) progression (three consecutive rises of PSA measured at least 1 week apart with two > 50% increases over the nadir and PSA > 2 ng/ml) or radiological disease progression (appearance of two or more lesions in bone scan or soft tissue enlargement as per RECIST criteria) with serum testosterone at castrate level (< 1.73 nmol/l; 50 ng/dl) during ADT.
- Being tested
- Atorvastatin 80mg, Placebo oral capsule
- Keywords
- Prostate cancer, Castration resistance, Cholesterol lowering drug, Cholesterol, Atorvastatin, Survival, Mortality
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Atorvastatin 80mgDrug
Also called Lipitor
Capsules including 80 mg of atorvastatin
Placebo oral capsuleDrug
Similar capsules as in the atorvastatin arm, but without the active ingredient
| Study group | Role | What they receive |
|---|---|---|
| Atorvastatin | Experimental | Capsules of atorvastatin. Daily dose of 80 mg for max. 10 years or until development of castration resistance. Receives: Drug: Atorvastatin 80mg |
| Placebo | Placebo comparator | Identical capsules as in the atorvastatin arm, but including no active ingredient. Used daily for max. 10 years or until development of castration resistance Receives: Drug: Placebo oral capsule |
What is being measured
The primary outcome is the main question the study is designed to answer.
Castration resistance
Castration resistance is defined as PSA progression (three consecutive PSA rises measured at least 1 week apart with two > 50% increases over the nadir and PSA > 2 ng/ml) or radiological disease progression (appearance of two or more lesions in bone scan or soft tissue enlargement as per RECIST criteria) with serum testosterone at castrate level (< 1.73 nmol/l; 50 ng/dl) during ADT.
Measured: From date of randomization until the date of first occurrence of castration resistance, assessed up to 60 months
Secondary outcomes (8)
Lipid levels
Change in serum lipid levels during the intervention. Measured at baseline and in every follow-up visit. Results are blinded from the investigators and participants before the final analysis
Measured: From date of randomization until the date of first occurrence of castration resistance or death, whichever came first, assessed at 6 month intervals up to 60 months
Prostate cancer mortality
Followed through Finnish national registries after reaching the primary end-point
Measured: From date of randomization until the date of prostate cancer death, assessed up to 60 months
Overall survival
Followed through Finnish national registries after reaching the primary end-point
Measured: From date of randomization until the date of death due to any cause, assessed up to 60 months
Circulating cell-free DNA
Occurrence of adverse tumor traits predicting development of castration resistance in circulating cell free DNA
Measured: At enrollment and at occurrence of castration resistance, assessed up to 60 months
Fasting blood glucose
To see how ADT affects glucose tolerance and whether atorvastatin intervention has any effect on it
Measured: From date of randomization until the date of first occurrence of castration resistance or death, whichever came first, assessed at 6 month intervals up to 60 months
Occurrence of cardiovascular events during ADT
Any cardiovascular events as described by the participant or evident from the patient files during the course of follow-up. Followed via national registries after meeting the primary end-point.
Measured: From date of randomization until the date of first occurrence of castration resistance or death, whichever came first, assessed at 6 month intervals up to 60 months
General quality of life (QOL)
Score from validated QOL questionnaire EORTC QLQ-C30 (range 0-100, with 100 denoting highest quality of life)
Measured: From date of randomization until the date of first occurrence of castration resistance or death, whichever came first, assessed at 12 month intervals up to 60 months
Prostate cancer-specific quality of life (QOL)
Score from validated QOL questionnaire EORTC QLQ-PR25 (range 0-100, with 100 denoting highest quality of life)
Measured: From date of randomization until the date of first occurrence of castration resistance or death, whichever came first, assessed at 12 month intervals up to 60 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2019
- Study start15 Aug 2019
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Metastatic Prostate CancerStudies of the same condition, open and under way.
- More trials run by Tampere 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tampere University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Turku University Hospital, Central Finland Hospital District, Tartu University Hospital, University of Aarhus, Fimlab laboratories, Helsinki University Central Hospital, Kuopio University Hospital, Oulu University Hospital, Seinajoki Central Hospital, The Hospital of Vestfold, Telemark Hospital Trust
- Responsible party
- Principal investigator, Teemu Murtola, Tampere University Hospital
- Investigators
- Teemu Murtola, MD, PhD, Principal investigator, Tampere University HospitalOtto Ettala, MD, PhD, Study director, Turku University HospitalHeikki Seikkula, Study director, Central Finland Hospital District
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04026230
- Sponsor's protocol ID
- 2016-004774-17
- Other IDs
- 2016
- Acronym
- ESTO2
- Status last verified
- Oct 2022
- First submitted
- 25 Jun 2018
- Last updated
- 21 Oct 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Sharing of individual-level data is not allowed by ethics board
Publications
Siltari A, Riikonen J, Koskimaki J, Pakarainen T, Ettala O, Bostrom P, Seikkula H, Kotsar A, Tammela T, Helminen M, Raittinen PV, Lehtimaki T, Fode M, Ostergren P, Borre M, Rannikko A, Marttila T, Salonen A, Ronkainen H, Loffeler S, Murtola TJ. Randomised double-blind phase 3 clinical study testing impact of atorvastatin on prostate cancer progression after initiation of androgen deprivation therapy: study protocol. BMJ Open. 2022 Apr 29;12(4):e050264. doi: 10.1136/bmjopen-2021-050264.
PubMed 35487730
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Atorvastatin on Prostate Cancer Progression After Initiation of Androgen Deprivation Therapy - Lipid Metabolism as a Novel Biomarker to Predict Prostate Cancer Progression
- ClinicalTrials.gov ID
- NCT04026230
- Acronym / sponsor ID
- ESTO2 / 2016-004774-17
- Keywords
- Prostate cancer, Castration resistance, Cholesterol lowering drug, Cholesterol, Atorvastatin, Survival, Mortality
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Tampere University HospitalUniversity, hospital or other
- Collaborators
- Turku University Hospital, Central Finland Hospital District, Tartu University Hospital, University of Aarhus, Fimlab laboratories, Helsinki University Central Hospital, Kuopio University Hospital, Oulu University Hospital, Seinajoki Central Hospital, The Hospital of Vestfold, Telemark Hospital Trust
- Study start
- 15 Aug 2019 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 19 Jul 2019 (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.
This randomized double-blind placebo-controlled trial tests whether intervention with atorvastatin delays development of castration resistance compared to placebo during androgen deprivation therapy (ADT) for prostate cancer.
Detailed description
Cholesterol-lowering statin drugs have been reported to lower proliferation activity in prostate cancer, delay occurrence of castration resistance and reduce the risk of prostate cancer death. Therefore, it is important to test statins' efficacy in addition to conventional prostate cancer treatment in a randomized, placebo-controlled trial.
This phase 3 randomized double-blind placebo-controlled trial will explore whether intervention with atorvastatin delays prostate cancer progression i.e. development of castration resistance compared to placebo during androgen deprivation therapy (ADT) for metastatic or recurrent prostate cancer.
Secondary objectives include exploring whether atorvastatin lowers prostate cancer-specific or overall mortality compared to placebo, and to demonstrate whether changes in serum lipid parameters predict disease recurrence and occurrence of adverse genomic changes predicting castration resistance among prostate cancer patients during ADT.
The study recruitment target is 400 participants who start ADT as management of metastatic or recurrent prostate cancer. These men will be randomized 1:1 (200 + 200) to receive blinded study drug, either 80 mg of atorvastatin daily or placebo until disease recurrence i.e. development of castration resistance or for a maximum of five years.
The study will be carried out in collaboration between urological departments of University Hospitals in Finland as a project of the national FinnProstata study group, Herlev University Hospital in Denmark, Vestfold and Telemark hospitals in Norway and the Tartu University Hospital in Estonia.
Follow-up is continued until the primary end-point, development of castration resistance. After this the participants will be given the opportunity to voluntarily carry on with the blinded intervention for maximum time of ten year to observe effects on survival after development of castration resistance. Blinding will be lifted after the follow-up is complete for all study participants.
Castration resistance is defined as prostate-specific antigen (PSA) progression (three consecutive rises of PSA measured at least 1 week apart with two > 50% increases over the nadir and PSA > 2 ng/ml) or radiological disease progression (appearance of two or more lesions in bone scan or soft tissue enlargement as per RECIST criteria) with serum testosterone at castrate level (< 1.73 nmol/l; 50 ng/dl) during ADT.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Atorvastatin | Experimental | Drug: Atorvastatin 80mgCapsules of atorvastatin. Daily dose of 80 mg for max. 10 years or until development of castration resistance. |
| Placebo | Placebo comparator | Drug: Placebo oral capsuleIdentical capsules as in the atorvastatin arm, but including no active ingredient. Used daily for max. 10 years or until development of castration resistance |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Histopathologically confirmed metastatic (radiologically confirmed bone or soft tissue metastasis or enlarged lymph nodes at minimum 15 mm in diameter beyond the pelvic lymph nodes) or recurrent (requiring treatment after curative-intent surgery or radiotherapy) adenocarcinoma of the prostate for which androgen deprivation or antiandrogen therapy (GnRH agonist/antagonist, bicalutamide/flutamide, surgical castration or enzalutamide/abiraterone monotherapy) is initiated as definitive treatment no longer than 3 months before recruitment
- Willingness to participate and signing of informed consent
Key exclusion criteria (5 listed)
- Statin use at the time of recruitment or within 6 months of it
- Previous adverse effects during statin therapy
- Familial hypercholesterolemia or very high total cholesterol (9.3 mmol/l or above)
- 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)
- 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).
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 |
|---|---|---|
| Atorvastatin 80mgAlso: LipitorCapsules including 80 mg of atorvastatin | Drug | Atorvastatin |
| Placebo oral capsuleSimilar capsules as in the atorvastatin arm, but without the active ingredient | Drug | Placebo |
Primary outcome
Castration resistance
Time frame: From date of randomization until the date of first occurrence of castration resistance, assessed up to 60 months
Castration resistance is defined as PSA progression (three consecutive PSA rises measured at least 1 week apart with two > 50% increases over the nadir and PSA > 2 ng/ml) or radiological disease progression (appearance of two or more lesions in bone scan or soft tissue enlargement as per RECIST criteria) with serum testosterone at castrate level (< 1.73 nmol/l; 50 ng/dl) during ADT.
8 secondary outcomes
Lipid levels
Time frame: From date of randomization until the date of first occurrence of castration resistance or death, whichever came first, assessed at 6 month intervals up to 60 months
Prostate cancer mortality
Time frame: From date of randomization until the date of prostate cancer death, assessed up to 60 months
Overall survival
Time frame: From date of randomization until the date of death due to any cause, assessed up to 60 months
Circulating cell-free DNA
Time frame: At enrollment and at occurrence of castration resistance, assessed up to 60 months
Fasting blood glucose
Time frame: From date of randomization until the date of first occurrence of castration resistance or death, whichever came first, assessed at 6 month intervals up to 60 months
Occurrence of cardiovascular events during ADT
Time frame: From date of randomization until the date of first occurrence of castration resistance or death, whichever came first, assessed at 6 month intervals up to 60 months
General quality of life (QOL)
Time frame: From date of randomization until the date of first occurrence of castration resistance or death, whichever came first, assessed at 12 month intervals up to 60 months
Prostate cancer-specific quality of life (QOL)
Time frame: From date of randomization until the date of first occurrence of castration resistance or death, whichever came first, assessed at 12 month intervals up to 60 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Oct 2022.
- Derived from this study: PubMed 35487730Siltari A, Riikonen J, Koskimaki J, Pakarainen T, Ettala O, Bostrom P, Seikkula H, Kotsar A, Tammela T, Helminen M, Raittinen PV, Lehtimaki T, Fode M, Ostergren P, Borre M, Rannikko A, Marttila T, Salonen A, Ronkainen H, Loffeler S, Murtola TJ. Randomised double-blind phase 3 clinical study testing impact of atorvastatin on prostate cancer progression after initiation of androgen deprivation therapy: study protocol. BMJ Open. 2022 Apr 29;12(4):e050264. doi: 10.1136/bmjopen-2021-050264.
- Individual participant dataSharing planned: No. Sharing of individual-level data is not allowed by ethics board
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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. This study is not recruiting at the moment.
Aino Siltari, PhD contact
Teemu Murtola, MD, PhD principal investigator
Tampere University Hospital
Otto Ettala, MD, PhD study director
Turku University Hospital
Heikki Seikkula study director
Central Finland Hospital District
10 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Atorvastatin 80mg in people with Metastatic Prostate Cancer and Recurrent Prostate Cancer, run by Tampere University Hospital at 10 sites in 4 countries.
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 4 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 21 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in Finland, Norway, Denmark, Estonia. 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. Some participants in this study may receive a placebo. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Teemu Murtola, MD, PhD (+358-3 311 65015, teemu.murtola@uta.fi), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Castration resistance (time frame: From date of randomization until the date of first occurrence of castration resistance, assessed up to 60 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04026230, which also lists 1 linked publication.
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 Oct 2022; AzTrials last refreshed its copy on 8 Nov 2026.