Status:
COMPLETED
Atorvastatin Before Prostatectomy and Prostate Cancer
Lead Sponsor:
Tampere University Hospital
Collaborating Sponsors:
Tampere University
Fimlab laboratories
Conditions:
Prostatic Neoplasms
Eligibility:
MALE
40-80 years
Phase:
PHASE2
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 tis...
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...
Eligibility Criteria
Inclusion
- Prostate cancer proven histologically in prostate biopsy
- Radical prostatectomy selected as the first-line treatment
- Willingness to participate and sign informed consent
Exclusion
- 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)
Key Trial Info
Start Date :
August 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2017
Estimated Enrollment :
160 Patients enrolled
Trial Details
Trial ID
NCT01821404
Start Date
August 1 2012
End Date
May 1 2017
Last Update
May 7 2018
Active Locations (3)
Enter a location and click search to find clinical trials sorted by distance.
1
Päijät-Häme Central Hospital
Lahti, Finland
2
Satakunta Central Hospital
Pori, Finland
3
Tampere University Hospital, Department of Urology
Tampere, Finland, 33521