Cellular Effect of Cholesterol-Lowering Prior to Prostate Removal

NCT02534376 | Completed Early Phase 1 FDA Drug

• 1 other identifier: Pro00040945
• Study Type: interventional
• Target: 63
• Locations: 1 country
• Sites: 1

Brief 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

Prostate Cancer

Keywords

prostatectomy, cholesterol, statin

Outcome Measures

Primary Outcomes (1)

• Growth of Gleason grade 3 prostate cancer

  Prostate tissue removed at the time of surgery will be examined to measure cellular growth using molecular assays.

  following 2-6 weeks of cholesterol lowering intervention.

Secondary Outcomes (2)

• Growth of benign prostate glands

  following 2-6 weeks of cholesterol lowering intervention.

• Growth of high grade prostate cancer (e.g. Gleason grade 4/5)

  following 2-6 weeks of cholesterol lowering intervention.

Study Arms (1)

Treatment

EXPERIMENTAL

Vytorin (ezetimibe 10mg-simvastatin 40mg)

Drug: ezetimibe 10mg-simvastatin 40mg

Interventions

ezetimibe 10mg-simvastatin 40mg DRUG

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.

Also known as: Vytorin

Treatment

Eligibility Criteria

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

You may qualify if:

• Biopsy containing ≥ 10 tissue cores sampled
• Biopsy positive for adenocarcinoma of the prostate containing any quantity of Gleason 3 component (e.g. Gleason score 3+3, 3+4, 4+3)
• Scheduled to undergo robotic radical prostatectomy
• Serum Prostate-Specific Antigen (PSA) \<20 ng/ml
• Ability to understand and the willingness to sign a written informed consent

You may not qualify if:

• Pharmacologic therapy (e.g. statins or ezetimibe) to lower cholesterol within 30 days prior to registration.
• Prior treatment for CaP by surgery, irradiation, local ablative (e.g. cryosurgery or high intensity focused ultrasound) or androgen deprivation therapy.
• alpha reductase inhibitors (e.g. finasteride or dutasteride) within 180 days prior to registration.
• Hypersensitivity to simvastatin or ezetimibe.
• Pharmacologic therapy with agents reported to produce adverse drug-drug interactions. (Table 2)

Sponsors & Collaborators

• Cedars-Sinai Medical Center: lead
• Roswell Park Cancer Institute: collaborator

Study Sites (1)

Cedars Sinai Medical Center

Los Angeles, California, 90048, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Ezetimibe; Simvastatin; Ezetimibe, Simvastatin Drug Combination

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Azetidines; Azetines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Lovastatin; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds; Drug Combinations; Pharmaceutical Preparations

Study Officials

• Hyung L Kim, MD

  Cedars-Sinai Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 25, 2015
• First Posted: August 27, 2015
• Study Start: September 1, 2015
• Primary Completion: February 28, 2019
• Study Completion: February 28, 2019
• Last Updated: February 22, 2023

Record last verified: 2023-02

Locations

US (1)