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The Impact of Atorvastatin on Prostate Cancer - a Randomized, Pre-surgical Clinical Trial

Phase 2
40 Years
80 Years
Open (Enrolling)
Prostatic Neoplasms

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Trial Information

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
the operation.

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.

Inclusion Criteria:

- Prostate cancer proven histologically in prostate biopsy

- Radical prostatectomy selected as the first-line treatment

- Willingness to participate and sign informed consent

Exclusion Criteria:

- Previous oncological treatments for any malignancy

- Previous usage of statins, finasteride or dutasteride within a year prior to prostate
cancer diagnosis

- Clinically significant liver- or kidney insufficiency (plasma alanine
aminotransferase level is twice over the recommended upper limit or serum creatinine
level is over 170 ┬Ámol/l)

- Previous adverse effects from cholesterol-lowering treatment

- Ongoing use of drugs having interactions with statins (St John's Wort, HIV protease
inhibitors, ciclosporin, macrolide antibiotics, fusidic acid, phenytoin,
carbamazepine, dronedarone or oral antifungal medication)

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Prevention

Outcome Measure:


Outcome Description:

Number of apoptotic cells in prostate tissue. Measured after radical prostatectomy, on average after 4 weeks of recruitment

Outcome Time Frame:

Four weeks after recruitment

Safety Issue:


Principal Investigator

Teemu J Murtola, M.D., Ph.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Tampere, School of Medicine


Finland: Pirkanmaa Hospital District

Study ID:




Start Date:

August 2012

Completion Date:

Related Keywords:

  • Prostatic Neoplasms
  • Apoptosis
  • Atorvastatin
  • Inflammation
  • Pre-surgical trial
  • Proliferation
  • Prostate cancer
  • Neoplasms
  • Prostatic Neoplasms