Atorvastatin Before Prostatectomy and Prostate Cancer

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

160 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-08-31

Study Completion Date

2017-05-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Prostatic Neoplasms

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Placebo

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

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

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

Atorvastatin

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

Group Type EXPERIMENTAL

Atorvastatin

Intervention Type DRUG

Capsules including 80 mg of atorvastatin

Interventions

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Atorvastatin

Capsules including 80 mg of atorvastatin

Intervention Type DRUG

Placebo

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

Intervention Type DRUG

Eligibility Criteria

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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)

Minimum Eligible Age

40 Years

Maximum Eligible Age

80 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No