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Eur Urol. 2018 Dec;74(6):697-701. doi: 10.1016/j.eururo.2018.06.037. Epub 2018 Jul 18.

Atorvastatin Versus Placebo for Prostate Cancer Before Radical Prostatectomy-A Randomized, Double-blind, Placebo-controlled Clinical Trial.

Author information

1
Faculty of Medicine and Life Sciences, University of Tampere, Tampere, Finland; Department of Urology, Tampere University Hospital, Tampere, Finland. Electronic address: teemu.murtola@uta.fi.
2
Faculty of Medicine and Life Sciences, University of Tampere, Tampere, Finland.
3
Fimlab Laboratories, Department of Pathology, Tampere, Finland.
4
Science Center, Pirkanmaa Hospital District, Tampere, Finland.
5
Department of Urology, Tampere University Hospital, Tampere, Finland.
6
Päijät-Häme Central Hospital, Lahti, Finland.
7
Faculty of Medicine and Life Sciences, University of Tampere, Tampere, Finland; Department of Urology, Tampere University Hospital, Tampere, Finland.

Abstract

We tested whether intervention with atorvastatin affects the prostate beneficially compared with placebo in men with prostate cancer in a randomized clinical trial. A total of 160 statin-naïve prostate cancer patients scheduled for radical prostatectomy were randomized to use 80mg atorvastatin or placebo daily from recruitment to surgery for a median of 27 d. Blinding was maintained throughout the trial. In total, 158 men completed the follow-up, with 96% compliance. Overall, atorvastatin did not significantly lower tumor proliferation index Ki-67 or serum prostate-specific antigen (PSA) compared with placebo. In subgroup analyses, after a minimum of 28 d of atorvastatin use, Ki-67 was 14.1% lower compared with placebo (p = 0.056). Among high-grade cases (International Society of Urological Pathology Gleason grade 3 or higher), atorvastatin lowered PSA compared with placebo: median change -0.6 ng/ml; p = 0.024. Intraprostatic inflammation did not differ between the study arms (p = 0.8). Despite a negative overall result showing no effect of statins on Ki67 or PSA overall, in post hoc exploratory analyses, there appeared to be benefit after a minimum duration of 28 d. Further studies are needed to verify this. PATIENT SUMMARY: Cholesterol-lowering atorvastatin does not lower prostate cancer proliferation rate compared with placebo overall, but exploratory analyses suggest a benefit in longer exposure.

KEYWORDS:

Atorvastatin; Clinical trial; Inflammation; Ki-67; Prostate cancer; Prostate-specific antigen

PMID:
30031572
DOI:
10.1016/j.eururo.2018.06.037
[Indexed for MEDLINE]

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