Adenocarcinoma of the Prostate Clinical Trial
Official title:
Phase II Study of Metformin in a Pre-prostatectomy Prostate Cancer Cohort
This randomized phase II trial studies how well metformin hydrochloride works compared to placebo in treating patients with prostate cancer undergoing surgery. Metformin hydrochloride may make some enzymes active. These enzymes may block other enzymes needed for cell growth and stop the growth of tumor cells.
PRIMARY OBJECTIVES:
I. To determine the effect of 4-12 weeks of metformin (metformin hydrochloride) intervention
on cell proliferation in the prostatectomy tissue.
SECONDARY OBJECTIVES:
I. To determine the effect of metformin intervention on prostate tissue bioavailability of
metformin.
II. To determine the effect of metformin intervention on apoptosis and angiogenesis in the
prostatectomy tissue.
III. To determine the effect of metformin intervention on potential molecular targets of
metformin including activated protein kinase (AMPK) activation, mammalian target of rapamycin
(mTOR) regulation, and cell cycle regulation in the prostatectomy tissue.
IV. To determine the effect of metformin intervention on changes in systemic hormones and
growth factors that have been shown to be modulated by metformin in other patient populations
including fasting glucose, fasting insulin, insulin-like growth factor axis, testosterone,
and sex hormone binding globulin (SHBG).
V. To determine the effect of metformin intervention on changes in prostate-specific antigen
(PSA) levels.
OUTLINE: Patients are randomized to 1 of 2 treatment arms.
ARM I: Patients receive extended-release metformin hydrochloride orally (PO) once daily (QD)
for 4-12 weeks.
ARM II: Patients receive placebo PO QD for 4-12 weeks.
Patients in both arms undergo surgery one day after completion of treatment.
After completion of study treatment, patients are followed up within 30 days of surgery.
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