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Prospective Study of Metformin in Castration-Resistant Prostate Cancer

Open (Enrolling)
Prostate Cancer

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Trial Information

Prospective Study of Metformin in Castration-Resistant Prostate Cancer

- 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.

Inclusion Criteria:

- Histologically or cytologically confirmed adenocarcinoma of the prostate

- History of bilateral orchiectomies or ongoing treatment with a GnRH agonist for GnRH

- Disease progression according to PSA Working Group 2

- Minimum starting PSA level of 2.0 ng/mL

- Easteron 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

Type of Study:


Study Design:

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

Outcome Measure:

PSA (prostate specific antigen) response

Outcome Description:

PSA response according to PSA Working Group criteria.

Outcome Time Frame:

2 years

Safety Issue:


Principal Investigator

Mattew R. Smith, MD, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Massachusetts General Hospital


United States: Food and Drug Administration

Study ID:




Start Date:

September 2010

Completion Date:

Related Keywords:

  • Prostate Cancer
  • castration-resistant prostate cancer
  • insulin levels
  • metformin
  • Prostatic Neoplasms



Beth Israel Deaconess Medical CenterBoston, Massachusetts  02215
Dana-Farber Cancer InstituteBoston, Massachusetts  02115
Massachusetts General HospitalBoston, Massachusetts  02114-2617