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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:

Apoptosis

Ki-67 expression

Histological inflammation

serum PSA

Secondary outcome:

serum cholesterol

Atorvastatin 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

Page last updated: August 23, 2015

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