Study of Metformin With Simvastatin for Men With Prostate Carcinoma

Prostate Carcinoma Clinical Trial

Official title: Open-Label Study Of Metformin In Combination With Simvastatin For Men With Prostate Carcinoma And A Rising Serum Prostate-Specific Antigen Level After Radical Prostatectomy And/Or Radiation Therapy

Status Withdrawn

Clinical Trial Summary

The purpose of this study is to find out whether the two drugs used in the study, metformin and simvastatin, can slow down the speed of rise of prostate specific antigen (PSA) or stop its rise or even bring the level down.

Recently, scientists noticed that men who take metformin to treat their high blood sugar or simvastatin to treat their high cholesterol are less likely to develop prostate cancer. Also, scientists found that, when these drugs are used in preclinical studies, they can slow down the growth of the prostate cancer cells. This study will try to find out whether these drugs can actually slow down the growth of prostate cancer in men.

Clinical Trial Description

Men who participate in this study will take both metformin and simvastatin every day. Both drugs are pills and can be taken at home.

Subjects will be asked to take metformin and simvastatin until metastasis from their prostate cancer appears or until their PSA has doubled from what it was before they started the study.

Primary Objective:

To define the efficacy, as measured by an improvement in PSA doubling time (PSADT) at 6 months, of the combination of metformin plus simvastatin in patients with recurrent prostate cancer following definitive treatment.

Secondary Objectives:

1. To define the time to protocol-specified event for men treated with the combination of metformin plus simvastatin.

2. To describe the pattern of change in log PSA levels and PSA velocity over time during treatment with metformin plus simvastatin.

3. To describe the associations between changes in metabolic parameters (fasting glucose/insulin/lipid panel/leptin/adiponectin and others) with the pattern of change in log PSA levels. ;

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma
• Prostate Carcinoma
• Prostatic Neoplasms

• NCT number: NCT01561482
• Study type: Interventional
• Source: Baylor College of Medicine
• Status: Withdrawn
• Phase: Phase 2
• Start date: January 2012
• Completion date: July 2014