Reduction of prostate cancer growth with cholesterol-lowering atorvastatin drug

Phase 1

• Conditions: 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]

• Registration Number: EUCTR2011-005438-20-FI
• Lead Sponsor: niversity of Tampere

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2012-05-04
• Last Update Posted: 28 February 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 160

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

Exclusion Criteria

- Any previous cancer treatment
- Usage of cholesterol-lowering medication, finasteride or dutasteride within a year from study inclusion
- Difficult renal or liver insufficiency
- Previous adverse effect during cholesterol-lowering treatment
- Usage of drugs or herbs during the study period that interact with atorvastatin (St John's Wort, HIV protease inhibitors, cyklosporin, macrolides, fusidic acid, phenytoin, carbamatsepin, dronedarone or oral antifungal drugs)

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: Reduction of intraprostatic inflammation and inhibition of prostate cancer growth with short-term atorvastatin treatment.;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.;Primary end point(s): 12-54% decrease in cell cycle activity, increased apoptosis, reduced lymphocyte infiltration in the prostate cancer tissue.;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 Measures

Name	Time	Method
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.