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Trial record 39 of 228 for:    metformin and cancer AND Hypoglycemic

Metformin in Castration-Resistant Prostate Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01215032
Recruitment Status : Terminated (slow accrual, competing clinical trials)
First Posted : October 5, 2010
Results First Posted : February 27, 2017
Last Update Posted : May 15, 2017
Sponsor:
Collaborators:
Dana-Farber Cancer Institute
Brigham and Women's Hospital
Beth Israel Deaconess Medical Center
Information provided by (Responsible Party):
Matthew R. Smith, MD, PhD, Massachusetts General Hospital

Brief Summary:
Metformin is a medication that is prescribed for people with diabetes to help the body respond better to its own insulin and decrease sugar production by the liver. This helps control the body's blood sugar level and is approved by the Food and Drug Administration (FDA) for the treatment of diabetes. Participant's in this research study will already be receiving androgen deprivation therapy (ADT) for prostate cancer. ADT is considered standard of care for prostate cancer. Changes in the participant's metabolism, including changes in insulin and blood sugar levels, are often seen as a result of this type of hormone therapy. Some studies have shown a relationship between insulin and prostate cancer. These studies have suggested that insulin may signal tumor cells to grow. Other studies suggest that people receiving metformin treatment for diabetes may enjoy better outcomes from their prostate cancer then other similar patients who are not treated with metformin.

Condition or disease Intervention/treatment Phase
Prostate Cancer Drug: Metformin Phase 2

Detailed Description:
  • Each treatment cycle lasts 4 weeks (28 days). Participants will take metformin twice a day for all 28 days (except for the first 7 days of the first cycle when they will take it just once daily.)
  • The following procedures will be done on Day 1 of treatment cycles 1, 2, 4, 7 and 10: medical history review, performance status, physical exam, blood tests.
  • If the participant's first computed tomography (CT) or bone scan at the time of screening showed evidence of cancer, CT and bone scans will be repeated on Day 1 of treatment cycles 4, 7 and 10.
  • Participants will be in this research study for about 12 months.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 21 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Prospective Study of Metformin in Castration-Resistant Prostate Cancer
Study Start Date : September 2010
Actual Primary Completion Date : January 2015
Actual Study Completion Date : January 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

Arm Intervention/treatment
Experimental: Metformin
This is the only arm of this phase 2 open label study
Drug: Metformin
Taken orally twice daily each 28-day cycle, for 12 cycles




Primary Outcome Measures :
  1. PSA (Prostate Specific Antigen) Response [ Time Frame: Approximately 12 weeks ]
    Percent change in PSA from baseline to 12 weeks.


Secondary Outcome Measures :
  1. Number of Participants With PSA Response [ Time Frame: 12 weeks ]
    PSA response is defined as a 50% decline from baseline confirmed by a second PSA value 4 weeks later.

  2. Relationship Between Baseline Metabolomic Profile and PSA Response [ Time Frame: 2 years ]
    To determine the plasma metabolomic profiles associated with response to metformin using the Metabolon platform. The Metabolon platform is a proprietary technique of metabolic profiling using mass spectrometry coupled with liquid and/or gas chromatography and robust bioinformatics. The aim is to test the hypothesis that insulin level is a biomarker that predicts activity of metformin therapy for the treatment of castrate-resistant prostate cancer.

  3. Percent Maintaining Glycemic Control [ Time Frame: 2 years ]
    To describe glycemic control as assessed by hemoglobin A1C. Glycemic control was defined as maintaining fasting plasma glucose levels less than or equal to 130 mg/dL. Plasma glucose levels were measured at baseline (prior to metformin dosing), pre-month 2, pre-month 4, pre-month 7, pre-month 10 and pre-month 13, and/or at off-study visit.



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Histologically or cytologically confirmed adenocarcinoma of the prostate
  • History of bilateral orchiectomies or ongoing treatment with a GnRH agonist for GnRH antagonist
  • Disease progression according to PSA Working Group 2
  • Minimum starting PSA (Prostate Specific Antigen) level of 2.0 ng/mL
  • Eastern Cooperative Oncology Group (ECOG) Performance Status 0 or 1

Exclusion Criteria:

  • Symptomatic metastases
  • Receiving any other agents for the treatment of prostate cancer except gonadotropin releasing hormone (GnRH) agonist or antagonist within the last 30 days
  • Received any investigational cancer treatment agents within the last 30 days
  • Prior treatment with docetaxel
  • History of diabetes requiring drug therapy
  • Current treatment with metformin or metformin treatment within the last year
  • History of allergic reaction to metformin
  • Have uncontrolled intercurrent illness including, but not limited to ongoing or unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
  • Serum creatinine 1.5mg/dL or greater
  • Hepatic impairment
  • Need for ongoing treatment with cimetidine
  • History of a different malignancy except for the following circumstances: Individuals with a history of other malignancies are eligible of they have been disease-free for at least 5 years and are deemed by the investigator to be at low risk for recurrence of that malignancy. Individuals with the following cancers are eligible if diagnosed and treated within the past 5 years: basal cell or squamous cell carcinoma of the skin

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01215032


Locations
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United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02115
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02115
Sponsors and Collaborators
Massachusetts General Hospital
Dana-Farber Cancer Institute
Brigham and Women's Hospital
Beth Israel Deaconess Medical Center
Investigators
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Principal Investigator: Matthew R. Smith, MD, PhD Massachusetts General Hospital

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Responsible Party: Matthew R. Smith, MD, PhD, Professor of Medicine, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT01215032     History of Changes
Other Study ID Numbers: 10-244
First Posted: October 5, 2010    Key Record Dates
Results First Posted: February 27, 2017
Last Update Posted: May 15, 2017
Last Verified: April 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Matthew R. Smith, MD, PhD, Massachusetts General Hospital:
castration-resistant prostate cancer
insulin levels
metformin

Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Metformin
Hypoglycemic Agents
Physiological Effects of Drugs