Back to resultsMetformin Prostate Cancer Adjuvant Trial
Primary Purpose
Prostate Cancer, Prostate Cancer Recurrent
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Metformin Hydrochloride Extended Release 750mg
Sponsored by
About this trial
This is an interventional treatment trial for Prostate Cancer focused on measuring Prostate Cancer, Prostate Cancer Recurrent
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
Sites / Locations
- Winthrop University Hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Experimental
Arm Label
Surgery - High Risk, Undetectable prostate-specific antigen (PSA)
Radiation - Rising PSA
Surgery - Rising PSA
Arm Description
Outcomes
Primary Outcome Measures
Mean Prostate Specific Antigen (PSA) Level
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02176161
Brief Title
Metformin Prostate Cancer Adjuvant Trial
Official Title
Phase II Clinical Study of Effect of Metformin on Prostate Specific Antigen Doubling Time
Study Type
Interventional
2. Study Status
Record Verification Date
September 2022
Overall Recruitment Status
Completed
Study Start Date
June 2014 (Actual)
Primary Completion Date
July 21, 2021 (Actual)
Study Completion Date
July 21, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
NYU Langone Health
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer, Prostate Cancer Recurrent
Keywords
Prostate Cancer, Prostate Cancer Recurrent
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
59 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Surgery - High Risk, Undetectable prostate-specific antigen (PSA)
Arm Type
Experimental
Arm Title
Radiation - Rising PSA
Arm Type
Experimental
Arm Title
Surgery - Rising PSA
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Metformin Hydrochloride Extended Release 750mg
Other Intervention Name(s)
Glucophage XR, Glumetza XR
Intervention Description
Metformin Hydrochloride Extended Release 750mg twice per day for 9 months.
Primary Outcome Measure Information:
Title
Mean Prostate Specific Antigen (PSA) Level
Time Frame
9 months
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Aaron E Katz, MD
Organizational Affiliation
NYU Winthrop Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Winthrop University Hospital
City
Mineola
State/Province
New York
ZIP/Postal Code
11501
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Metformin Prostate Cancer Adjuvant Trial
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