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Castration Compared to Castration Plus Metformin as First Line Treatment for Patients With Advanced Prostate Cancer

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ClinicalTrials.gov Identifier: NCT01620593
Recruitment Status : Completed
First Posted : June 15, 2012
Results First Posted : May 22, 2018
Last Update Posted : May 22, 2018
Sponsor:
Information provided by (Responsible Party):
The University of Texas Health Science Center at San Antonio

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Prostate Cancer
Interventions: Drug: Placebo
Drug: Metformin

  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
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Reporting Groups
  Description
Placebo and Castration

Metabolic consequences including development of hyperinsulinemia and insulin resistance using metformin compared to placebo in men on castration therapy.

Placebo and Castration: All eligible subjects will be randomized in a 1:l manner to receive a bottle containing sufficient 500mg tablets of metformin or placebo, blinded to the patient and the study team.

Metformin and Castration

Metabolic consequences including development of hyperinsulinemia and insulin resistance using metformin compared to placebo in men on castration therapy. In the rare case where a patient may not tolerate 500 mg three times a day, he may remain on the study taking only 500 mg twice a day.

Metformin and Castration: All eligible subjects will be randomized in a 1:l manner to receive a bottle containing sufficient500mg tablets of metformin or placebo, blinded to the patient and the study team.


Participant Flow:   Overall Study
    Placebo and Castration   Metformin and Castration
STARTED   21   20 
COMPLETED   17   19 
NOT COMPLETED   4   1 



  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
Placebo and Castration

Metabolic consequences including development of hyperinsulinemia and insulin resistance using metformin compared to placebo in men on castration therapy.

Placebo and Castration: All eligible subjects will be randomized in a 1:l manner to receive a bottle containing sufficient 500mg tablets of metformin or placebo, blinded to the patient and the study team.

Metformin and Castration

Metabolic consequences including development of hyperinsulinemia and insulin resistance using metformin compared to placebo in men on castration therapy. In the rare case where a patient may not tolerate 500 mg three times a day, he may remain on the study taking only 500 mg twice a day.

Metformin and Castration: All eligible subjects will be randomized in a 1:l manner to receive a bottle containing sufficient500mg tablets of metformin or placebo, blinded to the patient and the study team.

Total Total of all reporting groups

Baseline Measures
   Placebo and Castration   Metformin and Castration   Total 
Overall Participants Analyzed 
[Units: Participants]
 17   19   36 
Age 
[Units: Participants]
Count of Participants
     
<=18 years      0   0.0%      0   0.0%      0   0.0% 
Between 18 and 65 years      17 100.0%      19 100.0%      36 100.0% 
>=65 years      0   0.0%      0   0.0%      0   0.0% 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      0   0.0%      0   0.0%      0   0.0% 
Male      17 100.0%      19 100.0%      36 100.0% 
Region of Enrollment 
[Units: Participants]
Count of Participants
     
United States   17   19   36 


  Outcome Measures

1.  Primary:   Metabolic Syndrome   [ Time Frame: Change from 0 weeks to 28 weeks ]

2.  Primary:   Metabolic Syndrome Waist Circumference   [ Time Frame: Change from 12 to 28 weeks ]

3.  Secondary:   PSA Response   [ Time Frame: 28 weeks ]

4.  Secondary:   Treatment Failure   [ Time Frame: 1 year ]

5.  Secondary:   Number of Participants With Adverse Events   [ Time Frame: 1 year ]


  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
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  More Information

Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Sukeshi Arora, MD
Organization: UT Health San Antonio Cancer Center
phone: 210-450-1015
e-mail: aroras@uthscsa.edu



Responsible Party: The University of Texas Health Science Center at San Antonio
ClinicalTrials.gov Identifier: NCT01620593     History of Changes
Other Study ID Numbers: CTRC 10-21
HSC20110273H ( Other Identifier: UTHSCSA IRB )
First Submitted: May 31, 2012
First Posted: June 15, 2012
Results First Submitted: December 14, 2017
Results First Posted: May 22, 2018
Last Update Posted: May 22, 2018