The Impact of Atorvastatin on Prostate Cancer - a Randomized, Pre-surgical Clinical Trial
In this trial 160 men who have been diagnosed with prostate cancer, and whose first-line
treatment will be radical prostatectomy (surgical removal of the prostate), are randomized
to receive either 80 mg atorvastatin or placebo daily for 2-5 weeks until the operation.
Blood cholesterol and serum PSA are measured before starting the study drug use and before
After the operation histological inflammation, apoptotic rate and Ki-67 staining intensity
is compared between atorvastatin-treated and placebo-treated men. The correlation between
changes in serum cholesterol or prostate specific antigen (PSA) and the tissue
characteristics is evaluated.
Additionally, atorvastatin concentration in the blood and the prostate tissue is measured
with mass spectrometry to determine penetrance of atorvastatin into the prostate. DNA- and
RNA-samples are obtained from the prostate tissue and the blood. These will be used to study
how gene expression of statin- and cholesterol-modifying enzymes affects the responses
observed in prostate tissue.
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Prevention
Number of apoptotic cells in prostate tissue. Measured after radical prostatectomy, on average after 4 weeks of recruitment
Four weeks after recruitment
Teemu J Murtola, M.D., Ph.D.
University of Tampere, School of Medicine
Finland: Pirkanmaa Hospital District