Effect of Atorvastatin on Prostate Cancer Progression
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 study is testing if atorvastatin can help slow down the growth of advanced prostate cancer in men receiving hormone therapy.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 400 (estimated) |
| Ages | 18 Years and up |
| Sex | Male |
| Sponsor | Tampere University Hospital Academic / other |
| Drugs / interventions | radiation |
| Locations | 10 sites (Herlev and 9 other locations) |
| Trial ID | NCT04026230 on ClinicalTrials.gov |
What this trial studies
This phase 3 randomized double-blind placebo-controlled trial investigates whether atorvastatin can delay the progression of metastatic or recurrent prostate cancer during androgen deprivation therapy (ADT). The study will enroll 400 participants who will be randomly assigned to receive either atorvastatin or a placebo for up to five years. Secondary objectives include assessing the impact of atorvastatin on prostate cancer-specific mortality and exploring the relationship between serum lipid changes and disease recurrence. The trial is conducted in collaboration with multiple university hospitals in Finland.
Who should consider this trial
Good fit: Ideal candidates are men with histopathologically confirmed metastatic or recurrent prostate adenocarcinoma who are starting ADT.
Not a fit: Patients currently using statins or those with a history of adverse effects from statin therapy may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a new therapeutic approach to delay prostate cancer progression and improve survival rates for patients undergoing ADT.
How similar studies have performed: Previous studies have suggested that statins may lower prostate cancer proliferation and mortality, indicating potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Exclusion Criteria: * 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).
Where this trial is running
Herlev and 9 other locations
- Herlev and Gentofte Hospital — Herlev, Denmark (Not_yet_recruiting)
- Tartu University Hospital — Tartu, Estonia (Recruiting)
- Helsinki University Hospital, Department of Urology — Helsinki, Finland (Recruiting)
- Central Finland central hospital — Jyväskylä, Finland (Recruiting)
- Kuopio University Hospital, Department of Urology — Kuopio, Finland (Not_yet_recruiting)
- Seinäjoki Central Hospital, Department of Surgery — Seinäjoki, Finland (Recruiting)
- Tampere University Hospital — Tampere, Finland (Recruiting)
- Turku University Hospital — Turku, Finland (Recruiting)
- The Hospital of Telemark — Skien, Norway (Recruiting)
- The Hospital of Vestfold — Tønsberg, Norway (Recruiting)
Study contacts
- Principal investigator: Teemu Murtola, MD, PhD — Tampere University Hospital
- Study coordinator: Teemu Murtola, MD, PhD
- Email: teemu.murtola@uta.fi
- Phone: +358-3 311 65015
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.