Reduction of prostate cancer growth with cholesterol-lowering atorvastatin drug

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

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2011-005438-20-FI

Enrollment

160

Registered

2012-05-04

Start date

2012-05-22

Completion date

Unknown

Last updated

2019-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

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)

Interventions

Product Name: Atorvastatin Product Code: Atorvastatin Pharmaceutical Form: Tablet INN or Proposed INN: ATORVASTATIN CAS Number: 134523-0

Eligibility

Sex/Gender

Male

Inclusion criteria

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

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)

Design outcomes

Primary

Measure	Time frame
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.	—

Measure

Time frame

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

Measure	Time frame
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.	—

Measure

Time frame

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.

—

Countries

Finland

Contacts

Public ContactSchool of Medicine

University of Tampere

teemu.murtola@uta.fi+358331166086

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026