Impact of Atorvastatin on Prostate Cancer Progression During ADT

Launched by TAMPERE UNIVERSITY HOSPITAL · Jul 17, 2019

Keywords

ClinConnect Summary

This clinical trial is studying whether the medication atorvastatin can help slow down the progression of prostate cancer in men who are receiving androgen deprivation therapy (ADT), which is a common treatment for advanced prostate cancer. The goal is to see if atorvastatin can delay the time it takes for the cancer to become resistant to this treatment. The trial is currently looking for male participants aged 65 to 74 who have been diagnosed with metastatic or recurrent prostate cancer and are starting ADT.

Eligible participants should have been diagnosed with prostate cancer that has spread or returned after treatment. They should not have used statins (a type of cholesterol-lowering medication) recently and should not have certain health conditions that could complicate the study. If you choose to participate, you will be randomly assigned to receive either atorvastatin or a placebo (a substance with no therapeutic effect) and will be monitored for how your cancer responds to the treatment. It's important to note that this study is done in a way that neither you nor the researchers will know which treatment you are receiving, ensuring fair results.

Gender

MALE

Eligibility 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).