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Metformin Hydrochloride in Treating Patients With Prostate Cancer Undergoing Surgery

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ClinicalTrials.gov Identifier: NCT01433913
Recruitment Status : Completed
First Posted : September 14, 2011
Results First Posted : May 15, 2015
Last Update Posted : January 10, 2018
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, 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

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 (one 500 mg metformin tablet daily for the first week, followed by two 500 mg metformin tablets daily for the second week, and then three 500 mg tablets daily until the day before surgery) for 4-12 weeks.
Arm II (Placebo) Patients receive placebo PO QD (one placebo tablet daily for the first week, followed by two placebo tablets daily for the second week, and then three placebo tablets daily until the day before surgery) for 4-12 weeks.

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



  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 (one 500 mg metformin tablet daily for the first week, followed by two 500 mg metformin tablets daily for the second week, and then three 500 mg metformin tablets until the day before surgery) for 4-12 weeks.
Arm II (Placebo) Patients receive placebo PO QD (one placebo tablet daily for the first week, followed by two placebo tablets daily for the second week, and then three placebo tablets until the day before surgery) for 4-12 weeks.
Total Total of all reporting groups

Baseline Measures
   Arm I (Metformin Hydrochloride)   Arm II (Placebo)   Total 
Overall Participants Analyzed 
[Units: Participants]
 10   10   20 
Age 
[Units: Participants]
Count of Participants
     
<=18 years      0   0.0%      0   0.0%      0   0.0% 
Between 18 and 65 years      4  40.0%      6  60.0%      10  50.0% 
>=65 years      6  60.0%      4  40.0%      10  50.0% 
Age 
[Units: Years]
Mean (Standard Deviation)
 65  (10)   61  (6)   63  (8) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      0   0.0%      0   0.0%      0   0.0% 
Male      10 100.0%      10 100.0%      20 100.0% 
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 ]

3.  Secondary:   Apoptosis Levels in the Prostatectomy Tissue as Assessed by IHC of Cleaved Caspase 3   [ Time Frame: 12 weeks ]

4.  Secondary:   Cell Cycle Regulation in the Prostatectomy Tissue as Assessed by IHC of Cyclin D1   [ Time Frame: 12 weeks ]

5.  Secondary:   mTOR Regulation in the Prostatectomy Tissue as Assessed by IHC of Phospho-p70 S6 Kinase (p-p70S6K)   [ Time Frame: 12 weeks ]

6.  Secondary:   Angiogenesis in the Prostatectomy Tissue as Assessed by IHC of CD34   [ Time Frame: 12 weeks ]

7.  Secondary:   AMPK Activation in the Prostatectomy Tissue as Assessed by IHC of p-AMPK   [ Time Frame: 12 weeks ]

8.  Secondary:   Cell Cycle Regulation in the Prostatectomy Tissue as Assessed by IHC of Retinoblastoma Protein Phosphorylation (p-pRb)   [ Time Frame: 12 weeks ]

9.  Secondary:   Changes in Serum PSA   [ Time Frame: Baseline and 12 weeks ]

10.  Secondary:   Changes in Serum Fasting Insulin   [ Time Frame: Baseline and 12 weeks ]

11.  Secondary:   Changes in Serum IGF-1/IGFBP-3   [ Time Frame: Baseline and 12 weeks ]

12.  Secondary:   Changes in Serum Testosterone   [ Time Frame: Baseline and 12 weeks ]

13.  Secondary:   Changes in Serum SHBG   [ Time Frame: Baseline and 12 weeks ]

14.  Secondary:   Changes in Serum Fasting Glucose   [ Time Frame: Baseline and 12 weeks ]


  Serious Adverse Events


  Other Adverse Events


  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

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



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 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
CDR0000712087
UARIZ-UAZ10-16-01
11-0211-04 ( Other Identifier: Arizona Cancer Center - Tucson )
UAZ10-16-01 ( Other Identifier: DCP )
N01CN35158 ( U.S. NIH Grant/Contract )
P30CA023074 ( U.S. NIH Grant/Contract )
First Submitted: September 9, 2011
First Posted: September 14, 2011
Results First Submitted: April 29, 2015
Results First Posted: May 15, 2015
Last Update Posted: January 10, 2018