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Metformin in Castration-Resistant Prostate Cancer

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ClinicalTrials.gov Identifier: NCT01215032
Recruitment Status : Terminated (slow accrual, competing clinical trials)
First Posted : October 5, 2010
Results First Posted : February 27, 2017
Last Update Posted : May 15, 2017
Sponsor:
Collaborators:
Dana-Farber Cancer Institute
Brigham and Women's Hospital
Beth Israel Deaconess Medical Center
Information provided by (Responsible Party):
Matthew R. Smith, MD, PhD, Massachusetts General Hospital

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Prostate Cancer
Intervention Drug: Metformin
Enrollment 21
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Metformin
Hide Arm/Group Description

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

Metformin: Taken orally twice daily each 28-day cycle

Period Title: Overall Study
Started 21
Completed 1
Not Completed 20
Reason Not Completed
Adverse Event             3
Lack of Efficacy             17
Arm/Group Title Metformin
Hide Arm/Group Description

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

Metformin: Taken orally twice daily each 28-day cycle

Overall Number of Baseline Participants 21
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 21 participants
<=18 years
0
   0.0%
Between 18 and 65 years
8
  38.1%
>=65 years
13
  61.9%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 21 participants
65.86  (7.23)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 21 participants
Female
0
   0.0%
Male
21
 100.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 21 participants
Hispanic or Latino
0
   0.0%
Not Hispanic or Latino
9
  42.9%
Unknown or Not Reported
12
  57.1%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 21 participants
American Indian or Alaska Native
0
   0.0%
Asian
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
1
   4.8%
White
18
  85.7%
More than one race
0
   0.0%
Unknown or Not Reported
2
   9.5%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 21 participants
21
1.Primary Outcome
Title PSA (Prostate Specific Antigen) Response
Hide Description Percent change in PSA from baseline to 12 weeks.
Time Frame Approximately 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Metformin
Hide Arm/Group Description:

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

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

Overall Number of Participants Analyzed 21
Median (Full Range)
Unit of Measure: percentage of baseline PSA
161
(96.1 to 309.5)
2.Secondary Outcome
Title Number of Participants With PSA Response
Hide Description PSA response is defined as a 50% decline from baseline confirmed by a second PSA value 4 weeks later.
Time Frame 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Metformin
Hide Arm/Group Description:

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

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

Overall Number of Participants Analyzed 21
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
3.Secondary Outcome
Title Relationship Between Baseline Metabolomic Profile and PSA Response
Hide Description 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.
Time Frame 2 years
Hide Outcome Measure Data
Hide Analysis Population Description
Data was not collected for this outcome measure because blood (plasma) samples were never run on the Metabolon platform, as the study was terminated early.
Arm/Group Title Metformin
Hide Arm/Group Description:

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

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

Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
4.Secondary Outcome
Title Percent Maintaining Glycemic Control
Hide Description 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.
Time Frame 2 years
Hide Outcome Measure Data
Hide Analysis Population Description
Participants were stratified based on baseline hemoglobin A1c. HbA1c < 6.0 is considered normal; HbA1c >/= 6.0 is considered abnormal.
Arm/Group Title Normal Baseline Hemoglobin A1c Abnormal Baseline Hemoglobin A1c
Hide Arm/Group Description:
Hemoglobin A1c less than 6.0 before metformin dosing began.
Hemoglobin A1c greater than or equal to 6.0 before metformin dosing began.
Overall Number of Participants Analyzed 15 6
Measure Type: Count of Participants
Unit of Measure: Participants
15
 100.0%
6
 100.0%
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Metformin
Hide Arm/Group Description

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

Metformin: Taken orally twice daily each 28-day cycle

All-Cause Mortality
Metformin
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Metformin
Affected / at Risk (%)
Total   0/21 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Metformin
Affected / at Risk (%)
Total   16/21 (76.19%) 
Endocrine disorders   
Hypothyroidism * 1  1/21 (4.76%) 
Eye disorders   
cataract * 1  1/21 (4.76%) 
Gastrointestinal disorders   
abdominal pain * 1  1/21 (4.76%) 
diarrhea * 1  10/21 (47.62%) 
flatulence * 1  2/21 (9.52%) 
frequent bowel movements * 1  1/21 (4.76%) 
nausea * 1  4/21 (19.05%) 
vomiting * 1  1/21 (4.76%) 
General disorders   
chills * 1  1/21 (4.76%) 
fatigue * 1  4/21 (19.05%) 
fever * 1  1/21 (4.76%) 
Generalized achiness * 1  1/21 (4.76%) 
Non-cardiac chest pain * 1  1/21 (4.76%) 
Metabolism and nutrition disorders   
anorexia * 1  3/21 (14.29%) 
hyperglycemia * 1  1/21 (4.76%) 
Vitamin D deficiency * 1  1/21 (4.76%) 
Musculoskeletal and connective tissue disorders   
Back pain * 1  1/21 (4.76%) 
Bone pain * 1  1/21 (4.76%) 
Buttock pain * 1  1/21 (4.76%) 
Chest wall pain * 1  1/21 (4.76%) 
Pain in extremity * 1  1/21 (4.76%) 
Numbness in Toes * 1  1/21 (4.76%) 
Numbness - buttocks * 1  1/21 (4.76%) 
Renal and urinary disorders   
Urinary frequency * 1  1/21 (4.76%) 
Urinary incontinence * 1  1/21 (4.76%) 
Respiratory, thoracic and mediastinal disorders   
Sore throat * 1  1/21 (4.76%) 
Skin and subcutaneous tissue disorders   
Rash maculo-papular * 1  1/21 (4.76%) 
Vascular disorders   
Hypertension * 1  1/21 (4.76%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, CTCAE (4.0)
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.
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Maria Kempner
Organization: Mass General Hospital Cancer Center
Phone: 508.533.4132
Responsible Party: Matthew R. Smith, MD, PhD, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT01215032     History of Changes
Other Study ID Numbers: 10-244
First Submitted: October 4, 2010
First Posted: October 5, 2010
Results First Submitted: January 9, 2017
Results First Posted: February 27, 2017
Last Update Posted: May 15, 2017