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Trial record 37 of 228 for:    metformin and cancer AND Hypoglycemic

Metformin Prostate Cancer Adjuvant Trial

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ClinicalTrials.gov Identifier: NCT02176161
Recruitment Status : Recruiting
First Posted : June 26, 2014
Last Update Posted : January 10, 2019
Sponsor:
Information provided by (Responsible Party):
NYU Langone Health

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.

Condition or disease Intervention/treatment Phase
Prostate Cancer Prostate Cancer Recurrent Drug: Metformin Hydrochloride Extended Release 750mg Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 70 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase II Clinical Study of Effect of Metformin on Prostate Specific Antigen Doubling Time
Actual Study Start Date : June 2014
Estimated Primary Completion Date : June 1, 2021
Estimated Study Completion Date : June 1, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Surgical Prostate Cancer Patients

Radical Prostatectomy patients with:

  1. High risk surgical pathology (Gleason 8 or higher, positive surgical margins, evidence of extra capsular extension or seminal vesicle invasion)
  2. Prior Radiation Therapy OR
  3. Prior Radiation Therapy with rising PSA.

Metformin Hydrochloride Extended Release 750mg twice per day for 9 months.

Drug: Metformin Hydrochloride Extended Release 750mg
Metformin Hydrochloride Extended Release 750mg twice per day for 9 months.
Other Names:
  • Glucophage XR
  • Glumetza XR

Experimental: Radiation Patients

Radiation Patients with Biochemical Recurrence (rising PSA).

Metformin Hydrochloride Extended Release 750mg twice per day for 9 months.

Drug: Metformin Hydrochloride Extended Release 750mg
Metformin Hydrochloride Extended Release 750mg twice per day for 9 months.
Other Names:
  • Glucophage XR
  • Glumetza XR




Primary Outcome Measures :
  1. Prostate Specific Antigen Doubling Time [ Time Frame: 9 months ]
    Determine if Metformin treatment can increase Prostate Specific Antigen Doubling time over 9 months of treatment.


Secondary Outcome Measures :
  1. Decrease Prostate Specific Antigen Levels [ Time Frame: 9 months ]
    Determine if treatment with Metformin will decrease serum Prostate Specific Antigen levels.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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

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): NCT02176161


Contacts
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Contact: Amanda Le Sueur, PhD 516-535-4184 amanda.lesueur@nyulangone.org

Locations
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United States, New York
Winthrop University Hospital Recruiting
Mineola, New York, United States, 11501
Principal Investigator: Aaron E Katz, MD         
Sponsors and Collaborators
NYU Langone Health
Investigators
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Principal Investigator: Aaron E Katz, MD NYU Winthrop Hospital

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Responsible Party: NYU Langone Health
ClinicalTrials.gov Identifier: NCT02176161     History of Changes
Other Study ID Numbers: WUH 14015
18-01662 ( Other Identifier: NYU Langone Institutional Review Board )
First Posted: June 26, 2014    Key Record Dates
Last Update Posted: January 10, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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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

Keywords provided by NYU Langone Health:
Prostate Cancer
Prostate Cancer Recurrent

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