Metformin Hydrochloride in Treating Patients With Prostate Cancer Undergoing Surgery
Condition: Adenocarcinoma of the Prostate; Recurrent Prostate Cancer; Stage I Prostate Cancer; Stage IIA Prostate Cancer; Stage IIB Prostate Cancer
MeSH terms: Prostatic Neoplasms
Intervention: metformin hydrochloride; placebo; laboratory biomarker analysis
Intervention description: Given PO; Given PO; Correlative studies
Intervention MeSH terms: Metformin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 20.0
Sex: Male
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      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.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Men will be eligible to this study if they are diagnosed with a histologically
             confirmed organ-confined adenocarcinoma of the prostate (PCa) treatable by
             prostatectomy and have a current PSA less than 50 ng/ml

          -  Have not received chemotherapy and/or radiation for any malignancy (excluding
             non-melanoma skin cancer and cancers confined to organs with removal as only
             treatment) in the past 5 years

          -  Eastern Cooperative Oncology Group (ECOG) performance status 0-1 (Karnofsky >= 70%)

          -  Leukocytes >= 3,000/uL

          -  Absolute neutrophil count >= 1,500/uL

          -  Platelets >= 100,000/uL

          -  Total bilirubin =< 1.5 times institutional upper limits of normal (ULN)

          -  Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase
             [SGOT])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT])
             =< 1.5 times institutional ULN

          -  Creatinine within normal institutional limits

          -  Willing to use adequate contraception (barrier method, abstinence, subject has had a
             vasectomy or partner is using effective birth control or is postmenopausal) for the
             duration of study participation

          -  Ability to understand and the willingness to sign a written informed consent document

        Exclusion Criteria:

          -  Type I or type II diabetic patients on treatment with any drug for diabetes or
             participants with fasting glucose >= 126 mg/dL

          -  History of impaired liver or kidney function

          -  Participants with a current history of high alcohol consumption (> 3 standard
             drinks/day) or binge drinking (5 or more drinks) in one session of 1-3 hours

          -  History of lactic acidosis or at increased risk for lactic acidosis such as patients
             with unstable or acute congestive heart failure who are at risk of hypoperfusion with
             hypoxemia

          -  Participants may not be receiving any other investigational agents

          -  History of allergic reactions attributed to compounds of similar chemical composition
             to metformin

          -  Uncontrolled intercurrent illness including, but not limited to, ongoing or active
             infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac
             arrhythmia, or psychiatric illness/social situations that would limit compliance with
             study requirements

          -  History of acute or chronic metabolic acidosis

          -  Concurrent use of cationic drugs (e.g., amiloride, digoxin, morphine, procainamide,
             quinidine, quinine, ranitidine, triamterene, trimethoprim, or vancomycin)

          -  Concurrent use of non-study metformin or other biguanides