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
|Condition or disease||Intervention/treatment||Phase|
|Prostate Cancer||Drug: Placebo Drug: Metformin||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||41 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Phase II, Randomized, Placebo Controlled, Double Blind, Prospective Study of Castration Compared to Castration Plus Metformin as First Line Treatment for Patients With Advanced Prostate Cancer.|
|Study Start Date :||April 2011|
|Actual Primary Completion Date :||July 2016|
|Actual Study Completion Date :||September 2016|
Placebo Comparator: Placebo
Metabolic consequences including development of hyperinsulinemia and insulin resistance using metformin compared to placebo in men on castration therapy.
All eligible subjects will be randomized in a 1:l manner to receive a bottle containing sufficient 500mg tablets of placebo after castration, blinded to the patient and the study team.
Active Comparator: Metformin
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.
All eligible subjects will be randomized in a 1:l manner to receive a bottle containing sufficient 500mg tablets of metformin after castration, blinded to the patient and the study team.
- Metabolic Syndrome [ Time Frame: Change from 0 weeks to 28 weeks ]Compare both cohorts of castrated men (metformin vs. placebo) with regard to metabolic consequences of castration therapy:change in weight.
- Metabolic Syndrome Waist Circumference [ Time Frame: Change from 12 to 28 weeks ]Compare both cohorts of castrated men (metformin vs. placebo) with regard to metabolic consequences of castration therapy:change in waist circumference.
- PSA Response [ Time Frame: 28 weeks ]Complete Response for PSA measure was defined as a PSA less than or equal to 4 ng/ml or undetectable value at 7 months.
- Treatment Failure [ Time Frame: 1 year ]Progression time from randomization to the earliest disease progression defined as an increase of 20% or more as per RECIST criteria. Patients will not be removed from protocol treatment for PSA progression alone in the first 12 weeks on this study. Further rise in PSA even in the absence of deterioration of pre-existing lesions will constitute treatment failure. Adverse event leading to withdrawal related to metformin or placebo or castration treatment. Death from any cause. Patients unwillingness to continue. Patient's non-compliance with taking the study intervention - 50% or higher.
- Number of Participants With Adverse Events [ Time Frame: 1 year ]
The safety and tolerability of metformin with castration therapy as compared to castration therapy alone as measured by the number of subjects experiencing adverse events using CTCAE (common terminology criteria for adverse events) version 4 criteria. Grades are assigned to each adverse event where:
Grade 1 is mild symptoms Grade 2 is moderate symptoms Grade 3 is severe or medically significant but not immediately life-threatening symptoms Grade 4 is life-threatening consequences, where urgent intervention is indicated Grade 5 is death related to the adverse event
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01620593
|United States, Texas|
|Cancer Therapy and Research Center University of Texas Health Science Center San Antonio|
|San Antonio, Texas, United States, 78229|
|Principal Investigator:||Devalingam Mahalingam, MD, PhD||University of Texas Health Science Center San Antonio|