Back to results

Metformin in Castration-Resistant Prostate Cancer

Primary Purpose

Prostate Cancer

Status

Terminated

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

Metformin

About this trial

This is an interventional treatment trial for Prostate Cancer focused on measuring castration-resistant prostate cancer, insulin levels, metformin

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)MaleDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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

Sites / Locations

Massachusetts General Hospital
Beth Israel Deaconess Medical Center
Dana-Farber Cancer Institute

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Metformin

Arm Description

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

Outcomes

Primary Outcome Measures

PSA (Prostate Specific Antigen) Response

Percent change in PSA from baseline to 12 weeks.

Secondary Outcome Measures

Number of Participants With PSA Response

PSA response is defined as a 50% decline from baseline confirmed by a second PSA value 4 weeks later.

Relationship Between Baseline Metabolomic Profile and PSA Response

To determine the plasma metabolomic profiles associated with response to metformin using the Metabolon platform. The Metabolon platform is a proprietary technique of metabolic profiling using mass spectrometry coupled with liquid and/or gas chromatography and robust bioinformatics. The aim is to test the hypothesis that insulin level is a biomarker that predicts activity of metformin therapy for the treatment of castrate-resistant prostate cancer.

Percent Maintaining Glycemic Control

To describe glycemic control as assessed by hemoglobin A1C. Glycemic control was defined as maintaining fasting plasma glucose levels less than or equal to 130 mg/dL. Plasma glucose levels were measured at baseline (prior to metformin dosing), pre-month 2, pre-month 4, pre-month 7, pre-month 10 and pre-month 13, and/or at off-study visit.

Full Information

NCT ID

NCT01215032

First Posted

October 4, 2010

Last Updated

April 3, 2017

Sponsor

Massachusetts General Hospital

Collaborators

Dana-Farber Cancer Institute, Brigham and Women's Hospital, Beth Israel Deaconess Medical Center

1. Study Identification

Unique Protocol Identification Number

NCT01215032

Brief Title

Metformin in Castration-Resistant Prostate Cancer

Official Title

Prospective Study of Metformin in Castration-Resistant Prostate Cancer

Study Type

Interventional

2. Study Status

Record Verification Date

April 2017

Overall Recruitment Status

Terminated

Why Stopped

slow accrual, competing clinical trials

Study Start Date

September 2010 (undefined)

Primary Completion Date

January 2015 (Actual)

Study Completion Date

January 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Massachusetts General Hospital

Collaborators

Dana-Farber Cancer Institute, Brigham and Women's Hospital, Beth Israel Deaconess Medical Center

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

Detailed Description

Each treatment cycle lasts 4 weeks (28 days). Participants will take metformin twice a day for all 28 days (except for the first 7 days of the first cycle when they will take it just once daily.) The following procedures will be done on Day 1 of treatment cycles 1, 2, 4, 7 and 10: medical history review, performance status, physical exam, blood tests. If the participant's first computed tomography (CT) or bone scan at the time of screening showed evidence of cancer, CT and bone scans will be repeated on Day 1 of treatment cycles 4, 7 and 10. Participants will be in this research study for about 12 months.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Prostate Cancer

Keywords

castration-resistant prostate cancer, insulin levels, metformin

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

21 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Metformin

Arm Type

Experimental

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Metformin

Intervention Description

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

Primary Outcome Measure Information:

Title

PSA (Prostate Specific Antigen) Response

Description

Percent change in PSA from baseline to 12 weeks.

Time Frame

Approximately 12 weeks

Secondary Outcome Measure Information:

Title

Number of Participants With PSA Response

Description

PSA response is defined as a 50% decline from baseline confirmed by a second PSA value 4 weeks later.

Time Frame

12 weeks

Title

Relationship Between Baseline Metabolomic Profile and PSA Response

Description

Time Frame

2 years

Title

Percent Maintaining Glycemic Control

Description

Time Frame

2 years

10. Eligibility

Sex

Male

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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 Exclusion Criteria: 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Matthew R. Smith, MD, PhD

Organizational Affiliation

Massachusetts General Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Massachusetts General Hospital

City

Boston

State/Province

Massachusetts

ZIP/Postal Code

02114

Country

United States

Facility Name

Beth Israel Deaconess Medical Center

City

Boston

State/Province

Massachusetts

ZIP/Postal Code

02115

Country

United States

Facility Name

Dana-Farber Cancer Institute

City

Boston

State/Province

Massachusetts

ZIP/Postal Code

02115

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Metformin in Castration-Resistant Prostate Cancer

We'll reach out to this number within 24 hrs