Trial record 1 of 1 for:        Phase II Study of Metformin in a Pre-prostatectomy Cohort
Previous Study | Return to List | Next Study

Metformin Hydrochloride in Treating Patients With Prostate Cancer Undergoing Surgery

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT01433913
First received: September 9, 2011
Last updated: April 29, 2015
Last verified: May 2014
Results First Received: April 29, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Treatment
Conditions: Adenocarcinoma of the Prostate
Recurrent Prostate Cancer
Stage I Prostate Cancer
Stage IIA Prostate Cancer
Stage IIB Prostate Cancer
Interventions: Drug: metformin hydrochloride
Other: placebo
Other: laboratory biomarker analysis

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Arm I (Metformin Hydrochloride)

Patients receive extended-release metformin hydrochloride PO QD for 4-12 weeks.

metformin hydrochloride: Given PO

laboratory biomarker analysis: Correlative studies

Arm II (Placebo)

Patients receive placebo PO QD for 4-12 weeks.

placebo: Given PO

laboratory biomarker analysis: Correlative studies


Participant Flow:   Overall Study
    Arm I (Metformin Hydrochloride)     Arm II (Placebo)  
STARTED     10     10  
COMPLETED     9     10  
NOT COMPLETED     1     0  



  Baseline Characteristics
  Hide Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Arm I (Metformin Hydrochloride)

Patients receive extended-release metformin hydrochloride PO QD for 4-12 weeks.

metformin hydrochloride: Given PO

laboratory biomarker analysis: Correlative studies

Arm II (Placebo)

Patients receive placebo PO QD for 4-12 weeks.

placebo: Given PO

laboratory biomarker analysis: Correlative studies

Total Total of all reporting groups

Baseline Measures
    Arm I (Metformin Hydrochloride)     Arm II (Placebo)     Total  
Number of Participants  
[units: participants]
  10     10     20  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     4     6     10  
>=65 years     6     4     10  
Age  
[units: years]
Mean (Standard Deviation)
  65  (10)     61  (6)     63  (8)  
Gender  
[units: participants]
     
Female     0     0     0  
Male     10     10     20  
Region of Enrollment  
[units: participants]
     
United States     10     10     20  



  Outcome Measures

1.  Primary:   Cell Proliferation in the Prostatectomy Tissue as Assessed by Ki67 Expression Using Immunohistochemistry (IHC)   [ Time Frame: 12 weeks ]

2.  Secondary:   Prostate Tissue Metformin Concentration Levels as Assessed by Liquid Chromatography Tandem Mass Spectrometry   [ Time Frame: 12 weeks ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

3.  Secondary:   Comparison of Apoptosis (Cleaved Caspase 3), Angiogenesis (CD34), AMPK Activation (p-AMPK), mTOR Regulation (p-p70S6K), Cell Cycle Regulation (Cyclin D1and p-pRb) in the Prostatectomy Tissue Between Study Groups as Assessed by IHC   [ Time Frame: 12 weeks ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

4.  Secondary:   Comparison of Changes in Serum PSA, Fasting Glucose, Fasting Insulin, IGF-1/IGFBP-3, Testosterone, and SHBG Between Study Groups as Assessed by Liquid Chromatography-tandem Mass Spectrometry Assay   [ Time Frame: Baseline and 12 weeks ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information
  Hide More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Dr. Sherry Chow
Organization: University of Arizona
phone: 520-626-3358
e-mail: schow@azcc.arizona.edu


No publications provided


Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT01433913     History of Changes
Obsolete Identifiers: NCT01528527
Other Study ID Numbers: NCI-2012-00243, NCI-2012-00243, CDR0000712087, UARIZ-UAZ10-16-01, 11-0211-04, UAZ10-16-01, N01CN35158, P30CA023074
Study First Received: September 9, 2011
Results First Received: April 29, 2015
Last Updated: April 29, 2015
Health Authority: United States: Food and Drug Administration