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Impact of atorvastatin on prostate cancer progression after initiation of androgen deprivation therapy
EU CTIS ID: 2024-517854-91-00
What this study is testing
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.
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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
You likely can't join if
- 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)
- 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)
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling male, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.