- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01215032
Metformin in Castration-Resistant Prostate Cancer
April 3, 2017 updated by: Matthew R. Smith, MD, PhD, Massachusetts General Hospital
Prospective Study of Metformin in Castration-Resistant Prostate Cancer
Metformin is a medication that is prescribed for people with diabetes to help the body respond better to its own insulin and decrease sugar production by the liver.
This helps control the body's blood sugar level and is approved by the Food and Drug Administration (FDA) for the treatment of diabetes.
Participant's in this research study will already be receiving androgen deprivation therapy (ADT) for prostate cancer.
ADT is considered standard of care for prostate cancer.
Changes in the participant's metabolism, including changes in insulin and blood sugar levels, are often seen as a result of this type of hormone therapy.
Some studies have shown a relationship between insulin and prostate cancer.
These studies have suggested that insulin may signal tumor cells to grow.
Other studies suggest that people receiving metformin treatment for diabetes may enjoy better outcomes from their prostate cancer then other similar patients who are not treated with metformin.
Study Overview
Detailed Description
- Each treatment cycle lasts 4 weeks (28 days). Participants will take metformin twice a day for all 28 days (except for the first 7 days of the first cycle when they will take it just once daily.)
- The following procedures will be done on Day 1 of treatment cycles 1, 2, 4, 7 and 10: medical history review, performance status, physical exam, blood tests.
- If the participant's first computed tomography (CT) or bone scan at the time of screening showed evidence of cancer, CT and bone scans will be repeated on Day 1 of treatment cycles 4, 7 and 10.
- Participants will be in this research study for about 12 months.
Study Type
Interventional
Enrollment (Actual)
21
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Massachusetts
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Boston, Massachusetts, United States, 02115
- Dana-Farber Cancer Institute
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Boston, Massachusetts, United States, 02114
- Massachusetts General Hospital
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Boston, Massachusetts, United States, 02115
- Beth Israel Deaconess Medical Center
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Genders Eligible for Study
Male
Description
Inclusion Criteria:
- Histologically or cytologically confirmed adenocarcinoma of the prostate
- History of bilateral orchiectomies or ongoing treatment with a GnRH agonist for GnRH antagonist
- Disease progression according to PSA Working Group 2
- Minimum starting PSA (Prostate Specific Antigen) level of 2.0 ng/mL
- Eastern Cooperative Oncology Group (ECOG) Performance Status 0 or 1
Exclusion Criteria:
- Symptomatic metastases
- Receiving any other agents for the treatment of prostate cancer except gonadotropin releasing hormone (GnRH) agonist or antagonist within the last 30 days
- Received any investigational cancer treatment agents within the last 30 days
- Prior treatment with docetaxel
- History of diabetes requiring drug therapy
- Current treatment with metformin or metformin treatment within the last year
- History of allergic reaction to metformin
- Have uncontrolled intercurrent illness including, but not limited to ongoing or unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
- Serum creatinine 1.5mg/dL or greater
- Hepatic impairment
- Need for ongoing treatment with cimetidine
- History of a different malignancy except for the following circumstances: Individuals with a history of other malignancies are eligible of they have been disease-free for at least 5 years and are deemed by the investigator to be at low risk for recurrence of that malignancy. Individuals with the following cancers are eligible if diagnosed and treated within the past 5 years: basal cell or squamous cell carcinoma of the skin
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Metformin
This is the only arm of this phase 2 open label study
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Taken orally twice daily each 28-day cycle, for 12 cycles
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
PSA (Prostate Specific Antigen) Response
Time Frame: Approximately 12 weeks
|
Percent change in PSA from baseline to 12 weeks.
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Approximately 12 weeks
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Participants With PSA Response
Time Frame: 12 weeks
|
PSA response is defined as a 50% decline from baseline confirmed by a second PSA value 4 weeks later.
|
12 weeks
|
Relationship Between Baseline Metabolomic Profile and PSA Response
Time Frame: 2 years
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To determine the plasma metabolomic profiles associated with response to metformin using the Metabolon platform.
The Metabolon platform is a proprietary technique of metabolic profiling using mass spectrometry coupled with liquid and/or gas chromatography and robust bioinformatics.
The aim is to test the hypothesis that insulin level is a biomarker that predicts activity of metformin therapy for the treatment of castrate-resistant prostate cancer.
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2 years
|
Percent Maintaining Glycemic Control
Time Frame: 2 years
|
To describe glycemic control as assessed by hemoglobin A1C.
Glycemic control was defined as maintaining fasting plasma glucose levels less than or equal to 130 mg/dL.
Plasma glucose levels were measured at baseline (prior to metformin dosing), pre-month 2, pre-month 4, pre-month 7, pre-month 10 and pre-month 13, and/or at off-study visit.
|
2 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Matthew R. Smith, MD, PhD, Massachusetts General Hospital
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2010
Primary Completion (Actual)
January 1, 2015
Study Completion (Actual)
January 1, 2015
Study Registration Dates
First Submitted
October 4, 2010
First Submitted That Met QC Criteria
October 4, 2010
First Posted (Estimate)
October 5, 2010
Study Record Updates
Last Update Posted (Actual)
May 15, 2017
Last Update Submitted That Met QC Criteria
April 3, 2017
Last Verified
April 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 10-244
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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