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Cellular Effect of Cholesterol-Lowering Prior to Prostate Removal

NCT02534376 · Status: COMPLETED · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 63

Last updated 2023-02-22

No results posted yet for this study

Summary

There is evidence in human studies as well as animal studies that treatments to lower cholesterol can reduce the risk of dying from prostate cancer.To decide if cholesterol-lowering therapy can slow the growth of prostate cancer, the investigators would like to lower cholesterol prior to surgery and then measure the growth of prostate cancers cells when the prostate has been removed. The investigators will use the combination of two drugs that is approved by the U.S. Food and Drug Administration to lower cholesterol. The drug combination is commercially available with a doctor's prescription and sold as Vytorin®. It is known that maximal cholesterol-lower effects are seen after 2 weeks of treatment with Vytorin®. Therefore, study patients receive at least 2 weeks, but no more than 6 weeks of Vytorin® prior to surgery.

Conditions

Interventions

DRUG

ezetimibe 10mg-simvastatin 40mg

Vytorin (ezetimibe 10mg-simvastatin 40mg) will be given on an outpatient basis. The drug will be taken orally each day until the subject undergoes radical prostatectomy. The start of Vytorin is timed so that patients get the last dose the day before surgery. Subjects receive a two to four weeks of Vytorin.

Sponsors & Collaborators

  • Roswell Park Cancer Institute

    collaborator OTHER

  • Cedars-Sinai Medical Center

    lead OTHER

Principal Investigators

  • Hyung L Kim, MD · Cedars-Sinai Medical Center

Study Design

Allocation
NA
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-09-30
Primary Completion
2019-02-28
Completion
2019-02-28
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02534376 on ClinicalTrials.gov