Results from the trial were published in the study, “Atorvastatin Versus Placebo for Prostate Cancer Before Radical Prostatectomy—A Randomized, Double-blind, Placebo-controlled Clinical Trial,” in the journal European Urology.
Atorvastin is a type of statin, which is a medication that lowers cholesterol. The use of statins is associated with improved prostate cancer-specific survival, and laboratory studies have shown that statins exert numerous anticancer effects. However, they have never been tested in prostate cancer patients in a randomized clinical trial.
To address this, researchers recruited 160 men with prostate cancer scheduled to undergo a prostatectomy at Tampere University Hospital in Finland to determine whether treatment with atorvastatin has any beneficial effects on prostate cancer, compared with a placebo.
Patients were randomized to receive either 80 mg of atorvastatin or a placebo from the day they were enrolled in the trial until they had surgery. Participants received the treatment for a median of 27 days, with 96% compliance.
Researchers evaluated a number of different parameters, including effect on tumor growth and levels of serum prostate-specific antigen (PSA) — a biomarker associated with prostate cancer development and commonly used to test the effectiveness of prostate cancer therapies.
Atorvastatin showed no positive effects on tumor proliferation or serum PSA levels, compared with patients treated with placebo.
However, when researchers analyzed the results by subgroups, patients who took atorvastatin for at least 28 days had a 14.1% decrease in tumor growth, compared with placebo.
Additionally, in patients with high-grade cancer, atorvastatin use was associated with reduced PSA levels, with a median decrease of 0.6 ng/ml, compared with patients treated with placebo.
Inflammation in the prostate did not significantly differ between the treatment and placebo groups
Results from this study indicate that short-term, high-dose intervention with atorvastatin is well-tolerated, but shows no benefit to patients.
However, tumor proliferation and serum PSA levels were reduced in some patients who took the medication for a longer period of time — suggesting that there may be some beneficial effects with long-term atorvastatin treatment.
“Despite a negative overall result showing no effect of statins on [proliferation] or PSA overall, in post hoc exploratory analyses, there appeared to be benefit after a minimum duration of 28 [days],” researchers conclude.