Castration Compared to Castration Plus Metformin as First Line Treatment for Patients With Advanced Prostate Cancer
|ClinicalTrials.gov Identifier: NCT01620593|
Recruitment Status : Completed
First Posted : June 15, 2012
Last Update Posted : September 22, 2016
|Condition or disease||Intervention/treatment||Phase|
|Prostate Cancer||Drug: Placebo and Castration Drug: Metformin and Castration||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||38 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 and Castration
Metabolic consequences including development of hyperinsulinemia and insulin resistance using metformin compared to placebo in men on castration therapy.
Drug: 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.
Active Comparator: 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.
Drug: 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.
- Metabolic Syndrome [ Time Frame: 1 year ]Compare both cohorts of castrated men (metformin vs. placebo) with regard to metabolic consequences of castration therapy.
- PSA response [ Time Frame: 1 year ]PSA response, 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.
- Pathway Inhibition [ Time Frame: 1 year ]Inhibition of the downstream targets of the mTOR pathway, 4E-BPI and p70S6K1 observed on peripheral blood mononuclear cells (PBMCs).
- Safety and Efficacy [ Time Frame: 1 year ]The safety and tolerability of metformin with castration therapy as compared to castration therapy alone as measured by CTCAE version 4 criteria.
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|