Tests atorvastatin in men with advanced prostate cancer on hormone therapy
Tests whether atorvastatin delays prostate cancer becoming resistant to hormone therapy.
Plain-language title generated from the registry record
Registry title: Impact of atorvastatin on prostate cancer progression after initiation of androgen deprivation therapy
Key facts
- Where
- Tartu Linn, EstoniaSee the site
- Phase
- Phase 3
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for men with metastatic prostate cancer, or high-risk prostate cancer that has come back, who started androgen deprivation therapy in the last 3 months. It tests atorvastatin against placebo.
- Age
- 18 years or older
- Sex
- Men only
- Disease stage
- Metastatic prostate cancer confirmed by tissue examination, or high-risk M0 prostate cancer that came back after surgery or radiotherapy. High risk means Gleason 8-10, PSA doubling time of 6 months or less, PSA of 20 ng/ml or more, or new lymph node metastases on imaging.
- Earlier treatment
- Androgen deprivation or antiandrogen therapy must have been started no more than 3 months before joining. Hormone therapy given before surgery or radiotherapy does not count. No statin use at recruitment or in the 6 months before.
Main reasons for not taking part
- Statin use now or within 6 months of recruitment
- Earlier side effects while taking a statin
- Familial hypercholesterolemia or total cholesterol of 9.3 mmol/l (360 mg/dL) or above
- Serious kidney problems (serum creatinine above 170 µmol/l (1.92 mg/dL)) or liver problems (ALT more than 2 times the upper limit of normal)
- Taking drugs that can interact with statins, or allergy to atorvastatin or its ingredients
Read by machine on 9 November 2026.
Where in Estonia
- Tartu University HospitalTartu Linn, EstoniaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record
Print a page for my doctorTrial details
- Who runs it
- Pirkanmaan hyvinvointialue
- Trial code
- EU 2024-517854-91-00
- Record updated
- 8 October 2026
- Original description
Whether intervention with atorvastatin delays prostate cancer progression i.e. development of castration resistance compared to placebo during androgen deprivation therapy (ADT) for advanced prostate cancer.Read full original descriptionShow less
Impact of atorvastatin on prostate cancer progression after initiation of androgen deprivation therapy – lipid metabolism as a novel biomarker to predict prostate cancer progression – phase 3, double-blind randomized clinical trial FinnProstata XV. ESTO2.
Whether intervention with atorvastatin delays prostate cancer progression i.e. development of castration resistance compared to placebo during androgen deprivation therapy (ADT) for advanced prostate cancer.
Inclusion: 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; 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. • High risk M0 prostate cancer defined when one of the following criteria fulfilled: o Primarily Gleason 8-10 cancer OR o PSA doubling time ≤ 6 months OR o PSA ≥ 20 ng/ml OR o new lymph node metastases in imaging o previous prostatectomy and radiation therapy allowed o ADT/antiandrogen therapy for neoadjuvant hormone therapy is not included; Willingness to participate and signing of informed consent.
Exclusion: Previous adverse effects during statin therapy; 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); 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); 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); Statin use at the time of recruitment or within 6 months of it.