Metformin Prostate Cancer Adjuvant Trial
Condition: Prostate Cancer; Prostate Cancer Recurrent
MeSH terms: Prostatic Neoplasms
Intervention: Metformin Hydrochloride Extended Release 750mg
Intervention description: Metformin Hydrochloride Extended Release 750mg twice per day for 9 months.
Intervention MeSH terms: Metformin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 59.0
Sex: Male
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Prostate Cancer; Prostate Cancer Recurrent

Summary:

      This is a Phase II clinical study to determine if Metformin can increase Prostate Specific
      Antigen (PSA) doubling time for patients with Prostate Cancer who have failed primary
      treatment with radiation, or surgical patients that are at high risk for recurrence based on
      surgical pathology. Men with confirmed prostate cancer and rising serum PSA levels will
      receive Metformin and will be monitored for PSA response and disease progression.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male > 18 years of age

          -  Biopsy confirmed adenocarcinoma of the prostate

          -  Able to swallow and retain oral medication

          -  Hemoglobin A1C <7.0%

          -  Able and willing to participate in the full 12 months of the study

          -  Able to understand instructions related to study procedures

          -  Able to read and write English

        Exclusion Criteria:

          -  Metastatic Prostate Cancer

          -  Prostate Specific Antigen Doubling Time < 6 months

          -  Prior Chemotherapy, hormonal therapy, oral glucocorticoid therapy,
             Gonadotropin-releasing hormone analogue therapy

          -  Current or previous use of 5α-reductase inhibitors, antiandrogen drugs, metformin,
             oral or injectable diabetes drug

          -  Diagnosis of Type 1 Diabetes Mellitus

          -  Known hypersensitivity to metformin

          -  any condition associated with increased risk of metformin associated lactic acidosis

          -  participation in any investigational or marketed drug trial within 30 days prior to
             screening or during study period

          -  any unstable, serious co-existing medical conditions including but not limited to
             myocardial infarction, coronary bypass surgery, unstable angina, cardiac arrhythmias,
             clinically evident congestive heart failure, or cerebrovascular accident within 6
             months prior to screening

          -  history of megaloblastic anemia

          -  abnormal liver function test (total bilirubin, aspartate aminotransferase, alanine
             aminotransferase, alkaline phosphatase or serum creatinine above upper limit of
             normal)

          -  history of other malignancies, with the exception of adequately treated non-melanoma
             skin cancer, stage 1 melanoma, non-muscle invasive bladder cancer, or other solid
             tumors curatively treated with no evidence of disease for at least 5 years

          -  history or current evidence of substance abuse within 12 months of screening

          -  history of any illness (including psychiatric) that, in the opinion of the
             investigator, might confound the results of the study or post an additional risk to
             the subject