Metformin Prostate Cancer Adjuvant Trial

Phase II Clinical Study of Effect of Metformin on Prostate Specific Antigen Doubling Time

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.

Study Overview

• Status: Completed
• Conditions: Prostate Cancer; Prostate Cancer Recurrent
• Intervention / Treatment: Drug: Metformin Hydrochloride Extended Release 750mg

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.

• Study Type: Interventional
• Enrollment (Actual): 59
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • New York
    • Mineola, New York, United States, 11501
      • Winthrop University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Surgery - High Risk, Undetectable prostate-specific antigen (PSA)	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 - Rising PSA	Drug: Metformin Hydrochloride Extended Release 750mg; Metformin Hydrochloride Extended Release 750mg twice per day for 9 months.; Other Names: Glucophage XR; Glumetza XR
Experimental: Surgery - Rising PSA	Drug: Metformin Hydrochloride Extended Release 750mg; Metformin Hydrochloride Extended Release 750mg twice per day for 9 months.; Other Names: Glucophage XR; Glumetza XR

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Mean Prostate Specific Antigen (PSA) Level	9 months

Collaborators and Investigators

• Sponsor: NYU Langone Health
• Investigators: Principal Investigator: Aaron E Katz, MD, NYU Winthrop Hospital

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2014
• Primary Completion (Actual): July 21, 2021
• Study Completion (Actual): July 21, 2021

Study Registration Dates

• First Submitted: June 24, 2014
• First Submitted That Met QC Criteria: June 24, 2014
• First Posted (Estimate): June 26, 2014

Study Record Updates

• Last Update Posted (Actual): October 18, 2022
• Last Update Submitted That Met QC Criteria: September 21, 2022
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Keywords: Prostate Cancer; Prostate Cancer Recurrent
• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Genital Neoplasms, Male; Prostatic Diseases; Prostatic Neoplasms; Hypoglycemic Agents; Physiological Effects of Drugs; Metformin
• Other Study ID Numbers: WUH 14015; 18-01662 (Other Identifier: NYU Langone Institutional Review Board)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• 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