Metformin in Castration-Resistant Prostate Cancer

NCT01215032 | Terminated Phase 2 Results DMC

• 1 other identifier: 10-244
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 3

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.

Conditions

Prostate Cancer

Keywords

castration-resistant prostate cancer; insulin levels; metformin

Outcome Measures

Primary Outcomes (1)

• PSA (Prostate Specific Antigen) Response

  Percent change in PSA from baseline to 12 weeks.

  Approximately 12 weeks

Secondary Outcomes (3)

• Number of Participants With PSA Response

  12 weeks

• Relationship Between Baseline Metabolomic Profile and PSA Response

  2 years

• Percent Maintaining Glycemic Control

  2 years

Study Arms (1)

Metformin

EXPERIMENTAL

This is the only arm of this phase 2 open label study

Drug: Metformin

Interventions

Metformin DRUG

Taken orally twice daily each 28-day cycle, for 12 cycles

Metformin

Eligibility Criteria

• Sex: male
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Massachusetts General Hospital: lead
• Dana-Farber Cancer Institute: collaborator
• Brigham and Women's Hospital: collaborator
• Beth Israel Deaconess Medical Center: collaborator

Study Sites (3)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02115, United States

Location

Dana-Farber Cancer Institute

Boston, Massachusetts, 02115, 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

Limitations and Caveats

Early termination due to slow accrual led to small numbers of subjects. Therefore, meaningful assessment of the study endpoints is severely limited by the small sample size.

Results Point of Contact

• Title: Maria Kempner
• Organization: Mass General Hospital Cancer Center

mkempner@partners.org

508.533.4132

Study Officials

• Matthew R. Smith, MD, PhD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine

Study Record Dates

• First Submitted: October 4, 2010
• First Posted: October 5, 2010
• Study Start: September 1, 2010
• Primary Completion: January 1, 2015
• Study Completion: January 1, 2015
• Last Updated: May 15, 2017
• Results First Posted: February 27, 2017

Record last verified: 2017-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)