NCT01561482

Study of Metformin With Simvastatin for Men With Prostate Carcinoma

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• Status: Withdrawn
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Nicholas Mitsiades · Academic / Other
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Prostate Carcinoma

Interventions

Type	Name	Description
DRUG	Metformin	Metformin treatment will be started at 500 mg twice daily (dose level -2), in order to minimize gastrointestinal discomfort and, if no gastrointestinal toxicity grade greater than 1, will be increased to 500 mg with breakfast/1000 mg at bedtime (dose level -1) 4 days later (+/- 1 day allowed). If no gastrointestinal toxicity grade greater than 1, it will be increased to 1000 mg twice daily (dose level 0) 10 days later (+/- 2 days allowed), which is the target dose for the remainder of the study. If gastrointestinal toxicity grade greater than 1 occurs during these first 4 weeks, the subject will be evaluated every 2 weeks until resolution of toxicity to grade less than or equal to 1 and, then, the metformin dose will be increased to the next dose level.
DRUG	Simvastatin	The simvastatin dose at treatment initiation will be 20 mg once daily (dose level -1), taken at bedtime for 2 weeks. After these 2 weeks, the subject will have blood work and, if no AST/ALT/CPK elevation grade greater than 1, will be escalated to 40 mg once daily (dose level 0), taken at bedtime. If AST or ALT or CPK elevation grade greater than 1 during the first 2 weeks, the subject will be evaluated every 2 weeks until resolution of toxicity to grade less than or equal to 1, and then the simvastatin dose will be increased to dose level 0.

Timeline

• Start date: 2012-01-01
• Primary completion: 2014-07-01
• Completion: 2014-07-01
• First posted: 2012-03-23
• Last updated: 2015-07-22

Locations

3 sites across 1 country: United States