NCT01821404

Brief Summary

This single-center, randomized, double-blind trial assesses the impact of short-term atorvastatin administration on proliferation activity, apoptotic rate and histological inflammation in prostate tissue.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
160

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Aug 2012

Longer than P75 for phase_2

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2012

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

March 22, 2013

Completed
10 days until next milestone

First Posted

Study publicly available on registry

April 1, 2013

Completed
4.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2017

Completed
Last Updated

May 7, 2018

Status Verified

May 1, 2018

Enrollment Period

4.8 years

First QC Date

March 22, 2013

Last Update Submit

May 4, 2018

Conditions

Prostatic Neoplasms

Keywords

ApoptosisAtorvastatinInflammationPre-surgical trialProliferationProstate cancer

Outcome Measures

Primary Outcomes (4)

  • Apoptosis

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

    Four weeks after recruitment

  • Ki-67 expression

    Cellular proliferation activity in prostate tissue as measured by Ki-67 expression. Measured after radical prostatectomy, on average after 4 weeks of recruitment

    Four weeks after recruitment

  • Histological inflammation

    Extent of histological inflammation in the prostate tissue as evaluated by study pathologist

    After prostatectomy

  • serum PSA

    Change in serum PSA level as measured before starting the study drug and again just before prostatectomy

    At recruitment and before prostatectomy

Secondary Outcomes (2)

  • serum cholesterol

    At recruitment and again four weeks after

  • Atorvastatin level in prostate tissue

    Four weeks after recruitment

Other Outcomes (3)

  • Genotype of cholesterol-metabolizing enzymes

    Post-hoc analysis, one year after recruitment completes

  • Genotype of statin-metabolizing enzymes

    Post hoc analysis, one year after recruitment completes

  • Erection function

    One year after prostatectomy

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Similar capsules as in the atorvastatin arm, but including no active ingredient. Used daily for 3-5 weeks before prostatectomy

Drug: Placebo

Atorvastatin

EXPERIMENTAL

Atorvastatin capsules orally, 80 mg daily for 3-5 weeks before prostatectomy

Drug: Atorvastatin

Interventions

AtorvastatinDRUG

Capsules including 80 mg of atorvastatin

Atorvastatin
PlaceboDRUG

Similar capsules as in the atorvastatin arm, but without the active ingredient

Placebo

Eligibility Criteria

Age40 Years - 80 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Prostate cancer proven histologically in prostate biopsy
  • Radical prostatectomy selected as the first-line treatment
  • Willingness to participate and sign informed consent

You may not qualify if:

  • 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 µmol/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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Päijät-Häme Central Hospital

Lahti, Finland

Location

Satakunta Central Hospital

Pori, Finland

Location

Tampere University Hospital, Department of Urology

Tampere, 33521, Finland

Location

Related Publications (1)

  • Raittinen PVH, Syvala H, Tammela TLJ, Hakkinen MR, Ilmonen P, Auriola S, Murtola TJ. Atorvastatin induces adrenal androgen downshift in men with prostate cancer: A post Hoc analysis of a pilot adaptive Randomised clinical trial. EBioMedicine. 2021 Jun;68:103432. doi: 10.1016/j.ebiom.2021.103432. Epub 2021 Jun 16.

    PMID: 34144486DERIVED

MeSH Terms

Conditions

Prostatic NeoplasmsInflammation

Interventions

Atorvastatin

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

PyrrolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsHeptanoic AcidsFatty AcidsLipids

Study Officials

  • Teemu J Murtola, M.D., Ph.D.

    Tampere University

    PRINCIPAL INVESTIGATOR

  • Teuvo LJ Tammela, M.D., Ph.D.

    Tampere University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical teacher

Study Record Dates

First Submitted

March 22, 2013

First Posted

April 1, 2013

Study Start

August 1, 2012

Primary Completion

May 1, 2017

Study Completion

May 1, 2017

Last Updated

May 7, 2018

Record last verified: 2018-05

Locations

FI(3)