Effects of short-term atorvastatin treatment on prostate cancer - a pre-surgical pilot trial

INTERVENTION: Product Name: Atorvastatin Product Code: Atorvastatin Pharmaceutical Form: Tablet INN or Proposed INN: ATORVASTATIN CAS Number: 134523‐00‐5 Pharmaceutical form of the placebo: Tablet Route of administration of the placebo: Oral use CONDITION: Prostate cancer ; MedDRA version: 14.1 Level: PT Classification code 10060862 Term: Prostate cancer System Organ Class: 10029104 ‐ Neoplasms benign, malignant and unspecified (incl cysts and polyps) Therapeutic area: Diseases [C] ‐ Cancer [C04] PRIMARY OUTCOME: Main Objective: Reduction of intraprostatic inflammation and inhibition of prostate cancer growth with short‐term atorvastatin treatment. Primary end point(s): 12‐54% decrease in cell cycle activity, increased apoptosis, reduced lymphocyte infiltration in the prostate cancer tissue. Secondary Objective: Clarification of correlations between prostate cancer growth response and changes in serum cholesterol parameters and prostate tissue cholesterol metabolism. Measurement of intraprostatic concentration of atorvastatin. Timepoint(s) of evaluation of this end point: After radical prostatectomy, i.e. in average four weeks from randomization to either study arm. SECONDARY OUTCOME: Secondary end point(s): Decreased serum PSA, correlation between prostate cancer growth activity and serum cholesterol parameters (total cholesterol, HDL, LDL, ApoA, Apoe), changes in protein expression of key cholesterol regulators in prostate tissue (HMGCR, LDL‐R, SREBP2, ABCA1). Measurable atorvastatin concentration in prostate tissue. Timepoint(s) of evaluation of this end point: After the entire data has been collected and all tissue and serum samples have been collected and analyzed. INCLUSION CRITERIA: ‐ Histologically confirmed diagnosis of prostate adenocarcinoma ‐ Radical prostatectomy is chosen as prostate cancer treatment ‐ No prior cancer treatments of any kind ‐ The patient agrees to participate and signs an informed consent Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18‐64 years) yes F.1.2.1 Number of subjects for this age range 120 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 40