Prostate Cancer Clinical Trial
Official title:
Metformin in Castration Resistant Prostate Cancer. A Multicenter Phase II Trial.
RATIONALE: Metformin hydrochloride may make some enzymes active. These enzymes may block
other enzymes needed for cell growth and stop the growth of tumor cells.
PURPOSE: This phase II trial is studying the safety of giving metformin hydrochloride as
first-line therapy in treating patients with locally advanced or metastatic prostate cancer.
OBJECTIVES:
- To determine the activity and safety of metformin hydrochloride as first-line therapy in
patients with locally advanced or metastatic castration-resistant prostate cancer.
OUTLINE: This is a multicenter study.
Patients receive oral metformin hydrochloride twice daily on days 1-28. Treatment repeats
every 4 weeks in the absence of disease progression or unacceptable toxicity.
Previously collected and post-treatment tumor tissue may be analyzed for PTEN status and
PI3kinase-dependent pathway activation via immunohistochemistry. Blood samples may also be
collected periodically and analyzed for biomarkers, pharmacogenetics, pharmacodynamics,
pharmacokinetics.
After completion of study therapy, patients are followed up every 3 months.
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