Metformin Prostate Cancer Adjuvant Trial

NCT02176161 | Completed Phase 2 Results FDA Drug

• 2 other identifiers: WUH 1401518-01662
• Study Type: interventional
• Target: 59
• Locations: 1 country
• Sites: 1

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.

Conditions

Prostate Cancer; Prostate Cancer Recurrent

Keywords

Prostate Cancer; Prostate Cancer Recurrent

Outcome Measures

Primary Outcomes (1)

• Mean Prostate Specific Antigen (PSA) Level

  9 months

Study Arms (3)

Surgery - High Risk, Undetectable prostate-specific antigen (PSA)

EXPERIMENTAL

Drug: Metformin Hydrochloride Extended Release 750mg

Radiation - Rising PSA

EXPERIMENTAL

Drug: Metformin Hydrochloride Extended Release 750mg

Surgery - Rising PSA

EXPERIMENTAL

Drug: Metformin Hydrochloride Extended Release 750mg

Interventions

Metformin Hydrochloride Extended Release 750mg DRUG

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

Also known as: Glucophage XR, Glumetza XR

Radiation - Rising PSA; Surgery - High Risk, Undetectable prostate-specific antigen (PSA); Surgery - Rising PSA

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• NYU Langone Health: lead

Study Sites (1)

Winthrop University Hospital

Mineola, New York, 11501, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Metformin

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Biguanides; Guanidines; Amidines; Organic Chemicals

Results Point of Contact

• Title: Aaron Katz, MD
• Organization: NYU Langone Health

Aaron.Katz@nyulangone.org

516-535-1900

Study Officials

• Aaron E Katz, MD

  NYU Winthrop Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 24, 2014
• First Posted: June 26, 2014
• Study Start: June 1, 2014
• Primary Completion: July 21, 2021
• Study Completion: July 21, 2021
• Last Updated: October 18, 2022
• Results First Posted: October 18, 2022

Record last verified: 2022-09

Locations

US (1)