Prostatic Neoplasms Clinical Trial
Official title:
The Impact of Atorvastatin on Prostate Cancer - a Randomized, Pre-surgical Clinical Trial
This single-center, randomized, double-blind trial assesses the impact of short-term atorvastatin administration on proliferation activity, apoptotic rate and histological inflammation in prostate tissue.
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 the
operation.
After the operation change in PSA and histological inflammation, apoptotic rate and Ki-67
staining intensity are 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.
After recruiting 60 men we will perform an interim analysis on primary end-points without
breaking the blinding to treatment allocation. If we observe a statistically significant
difference in all primary end-points, the trial will be stopped early and the results
published.
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.
As a secondary end-point we will measure recovery of erectile function after the operation
and compare between the two study arms. Erectile function is measured using IIEF-5
questionnaire once before the operation and again 3, 6, 9 and 12 months from the
prostatectomy.
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