Clinical Trials /

Metformin Prostate Cancer Adjuvant Trial

NCT02176161

Description:

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.

Related Conditions:
  • Prostate Adenocarcinoma
Recruiting Status:

Recruiting

Phase:

Phase 2

Trial Eligibility

Document

Title

  • Brief Title: Metformin Prostate Cancer Adjuvant Trial
  • Official Title: Phase II Clinical Study of Effect of Metformin on Prostate Specific Antigen Doubling Time

Clinical Trial IDs

  • ORG STUDY ID: WUH 14015
  • SECONDARY ID: 18-01662
  • NCT ID: NCT02176161

Conditions

  • Prostate Cancer
  • Prostate Cancer Recurrent

Interventions

DrugSynonymsArms
Metformin Hydrochloride Extended Release 750mgGlucophage XR, Glumetza XRSurgical Prostate Cancer Patients

Purpose

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.

Detailed Description

      Prostate cancer patients who have received treatment with radiation therapy or surgery, who
      have indicators of high-risk disease will be administered 750mg Metformin Extended Release
      twice per day for a period of 9 months. Metformin is an FDA-approved drug that is prescribed
      to treat high blood sugar levels in patients with Type 2 Diabetes. To track prostate cancer
      response in study participants, investigators will obtain prostate specific antigen (PSA)
      levels every three months for the duration of the trial.
    

Trial Arms

NameTypeDescriptionInterventions
Surgical Prostate Cancer PatientsExperimentalRadical Prostatectomy patients with: High risk surgical pathology (Gleason 8 or higher, positive surgical margins, evidence of extra capsular extension or seminal vesicle invasion) Prior Radiation Therapy OR Prior Radiation Therapy with rising PSA. Metformin Hydrochloride Extended Release 750mg twice per day for 9 months.
  • Metformin Hydrochloride Extended Release 750mg
Radiation PatientsExperimentalRadiation Patients with Biochemical Recurrence (rising PSA). Metformin Hydrochloride Extended Release 750mg twice per day for 9 months.
  • Metformin Hydrochloride Extended Release 750mg

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
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:Male
Healthy Volunteers:No

Primary Outcome Measures

Measure:Prostate Specific Antigen Doubling Time
Time Frame:9 months
Safety Issue:
Description:Determine if Metformin treatment can increase Prostate Specific Antigen Doubling time over 9 months of treatment.

Secondary Outcome Measures

Measure:Decrease Prostate Specific Antigen Levels
Time Frame:9 months
Safety Issue:
Description:Determine if treatment with Metformin will decrease serum Prostate Specific Antigen levels.

Details

Phase:Phase 2
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:NYU Langone Health

Trial Keywords

  • Prostate Cancer
  • Prostate Cancer Recurrent

Last Updated

January 8, 2019