Atorvastatin Before Prostatectomy and Prostate Cancer
Information source: Tampere University Hospital
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Prostatic Neoplasms
Intervention: Atorvastatin (Drug); Placebo (Drug)
Phase: Phase 2
Status: Recruiting
Sponsored by: Tampere University Hospital Official(s) and/or principal investigator(s): Teemu J Murtola, M.D., Ph.D., Principal Investigator, Affiliation: University of Tampere, School of Medicine Teuvo LJ Tammela, M.D., Ph.D., Study Director, Affiliation: University of Tampere, School of Medicine
Overall contact: Teemu J Murtola, M.D., Ph.D., Phone: +358 40 5813177, Email: teemu.murtola@uta.fi
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.
Clinical Details
Official title: The Impact of Atorvastatin on Prostate Cancer - a Randomized, Pre-surgical Clinical Trial
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Prevention
Primary outcome: ApoptosisKi-67 expression Histological inflammation serum PSA
Secondary outcome: serum cholesterolAtorvastatin level in prostate tissue
Detailed description:
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 change in PSA and histological inflammation, apoptotic rate and Ki-67
staining intensity are 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.
After recruiting 60 men we will perform an interim analysis on primary end-points without
breaking the blinding to treatment allocation. If we observe a statistically significant
difference in all primary end-points, the trial will be stopped early and the results
published.
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.
As a secondary end-point we will measure recovery of erectile function after the operation
and compare between the two study arms. Erectile function is measured using IIEF-5
questionnaire once before the operation and again 3, 6, 9 and 12 months from the
prostatectomy.
Eligibility
Minimum age: 40 Years.
Maximum age: 80 Years.
Gender(s): Male.
Criteria:
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 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)
Locations and Contacts
Teemu J Murtola, M.D., Ph.D., Phone: +358 40 5813177, Email: teemu.murtola@uta.fi
Päijät-Häme Central Hospital, Lahti, Finland; Not yet recruiting Taina Isotalo, MD, PhD, Email: taina.isotalo@phsotey.fi Taina Isotalo, MD, PhD, Principal Investigator
Satakunta Central Hospital, Pori, Finland; Not yet recruiting Antti Kaipia, MD, PhD, Email: antti.kaipia@satshp.fi Antti Kaipia, MD, PhD, Principal Investigator
Tampere University Hospital, Department of Urology, Tampere 33521, Finland; Recruiting Teuvo LJ Tammela, M.D., Ph.D., Phone: +358 3 311 646 21, Email: teuvo.tammela@uta.fi Juha Koskimäki, M.D., Ph.D., Phone: +358 3 311 67673, Email: juha.koskimaki@pshp.fi Teemu J Murtola, M.D., Ph.D., Principal Investigator Teuvo LJ Tammela, M.D., Ph.D., Sub-Investigator Juha Koskimäki, M.D., Ph.D., Sub-Investigator Jarno Riikonen, M.D., Ph.D., Sub-Investigator Antti Kaipia, M.D., Ph.D., Sub-Investigator
Additional Information
Starting date: August 2012
Last updated: May 11, 2015
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