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.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
PSA (prostate specific antigen) response
PSA response according to PSA Working Group criteria.
Mattew R. Smith, MD, PhD
Massachusetts General Hospital
United States: Food and Drug Administration
|Beth Israel Deaconess Medical Center||Boston, Massachusetts 02215|
|Dana-Farber Cancer Institute||Boston, Massachusetts 02115|
|Massachusetts General Hospital||Boston, Massachusetts 02114-2617|