Prospective Study of Metformin in Castration-Resistant Prostate Cancer
Overview
- Phase
- Phase 2
- Intervention
- Metformin
- Conditions
- Prostate Cancer
- Sponsor
- Massachusetts General Hospital
- Enrollment
- 21
- Locations
- 3
- Primary Endpoint
- PSA (Prostate Specific Antigen) Response
- Status
- Terminated
- Last Updated
- 8 years ago
Overview
Brief Summary
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.
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.
Investigators
Matthew R. Smith, MD, PhD
Professor of Medicine
Massachusetts General Hospital
Eligibility Criteria
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
Arms & Interventions
Metformin
This is the only arm of this phase 2 open label study
Intervention: Metformin
Outcomes
Primary Outcomes
PSA (Prostate Specific Antigen) Response
Time Frame: Approximately 12 weeks
Percent change in PSA from baseline to 12 weeks.
Secondary Outcomes
- Number of Participants With PSA Response(12 weeks)
- Relationship Between Baseline Metabolomic Profile and PSA Response(2 years)
- Percent Maintaining Glycemic Control(2 years)