Statin Therapy Versus Placebo Prior to Prostatectomy

NCT00572468 | Completed Results DMC

• 3 other identifiers: CLIN-013-07SVA IRB#1735SOL-07130-L
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 2

Brief Summary

This is a randomized trial comparing the effect of oral simvastatin versus placebo on targets of the mevalonate pathway in men undergoing a prostatectomy as planned management for prostate cancer. Observed tissue effects will be correlated with changes in serum cholesterol and low-density lipoprotein.

Conditions

Cancer; Prostate Cancer

Keywords

cancer; pre-operative surgery; prostate; prostatectomy; radiation

Outcome Measures

Primary Outcomes (1)

• Measure the Effect of Pre-operative Simvastatin Versus Placebo on the Mevalonate Pathway Synthesis and Target Activation in Benign and Malignant Prostate Tissue.

  Measure the effect of pre-operative simvastatin versus placebo on the mevalonate pathway synthesis and target activation in benign and malignant prostate tissue using Androgen Receptor (AR) antibody. AR was measured in tissue obtained at the time of prostatectomy in both benign and malignant tissues.

  5 years

Secondary Outcomes (1)

• Compare the Effect of Pre-operative Simvastatin Versus Placebo on Prostate Cancer Cell Apoptosis and Its Mediators in Men Undergoing Planned Prostatectomy.

  2 years

Study Arms (2)

Simvastatin

ACTIVE COMPARATOR

Twenty-two men will be on the Statin arm and take 40 mg of simvastatin.

Drug: Simvastatin

Placebo

PLACEBO COMPARATOR

Twenty-two men will be on the placebo arm.

Other: Placebo

Interventions

Simvastatin DRUG

40 mg of simvastatin

Also known as: statin

Simvastatin

Placebo OTHER

placebo

Placebo

Eligibility Criteria

• Age: 21 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histologically confirmed prostatic adenocarcinoma with Gleason 5 to 7 (3+4 = 7 accepted, not 4 + 3 = 7)
• Radical prostatectomy chosen as primary treatment for prostate cancer
• Age 18 years or older
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1

You may not qualify if:

• Other preoperative or prior treatment directed at prostate cancer (i.e., Radiation, hormonal therapy, cryotherapy)
• Significant active medical illness which in the opinion of the investigator would preclude protocol treatment
• History of or active liver disease or abnormal results of the baseline liver function test (\> 2 x normal)
• Current use of:
• simvastatin
• lovastatin
• other HMG-CoA inhibitors
• lipid-lowering agents
• Amiodarone
• Cholestyramine
• Cholestyramine and colestipol (bile acid sequestrants)
• Clofibrate and fenofibrate
• Cyclosporine
• CYP3A4 inhibitors
• Danazol

Sponsors & Collaborators

• VA Office of Research and Development: lead
• Oregon Health and Science University: collaborator

Study Sites (2)

Durham VA Medical Center, Durham, NC

Durham, North Carolina, 27705, United States

Location

VA Medical Center, Portland

Portland, Oregon, 97201, United States

Location

MeSH Terms

Conditions

Neoplasms; Prostatic Neoplasms

Interventions

Simvastatin; Hydroxymethylglutaryl-CoA Reductase Inhibitors

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Lovastatin; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds; Anticholesteremic Agents; Hypolipidemic Agents; Antimetabolites; Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses; Enzyme Inhibitors; Lipid Regulating Agents; Therapeutic Uses

Results Point of Contact

• Title: Wesley Stoller
• Organization: Portland VA Health Care System

wesley.stoller@va.gov

503-220-8262

Study Officials

• Mark Garzotto, MD

  VA Medical Center, Portland

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 11, 2007
• First Posted: December 13, 2007
• Study Start: December 1, 2007
• Primary Completion: April 1, 2013
• Study Completion: April 30, 2017
• Last Updated: July 13, 2017
• Results First Posted: July 13, 2017

Record last verified: 2017-06

Locations

US (2)