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Examining the Effects of Medicincation and Hormone Therapy on PSA


Title Prostate Cancer - Examining the effects of Bicalutamide with or without MK-2206 on PSA
Therapeutic Area
Principal Investigator Paul Mathew, MD
Min Age 18 Years
Gender Male
Contact Jodi Jensen, RN
617-636-5558
More Information http://www.clinicaltrials.gov/

Overview

This study is being done to compare the effects, good and/or bad, of MK-2206 and Bicalutamide (a type of hormonal therapy), versus Bicalutamide alone on lowering PSA. In this study, subjects will receive either MK-2206 combined with Bicalutamide OR Bicalutamide alone. If they  are selected to receive Bicalutamide alone, they will not be eligible to receive MK-2206 as part of this study. The study will also evaluate the safety of the Bicalutamide and MK-2206 combination therapy.

Study Details

Inclusion Criteria

  • Must have histologically confirmed diagnosis of prostate cancer. 
  • Must have had previous treatment with definitive surgery or radiation therapy or cryoablation.

Exclusion Criteria

  • Must not have GI tract disease resulting in an inability to take oral medication, malabsorption syndrome, a requirement for IV alimentation, prior surgical procedures affecting absorption, uncontrolled inflammatory GI disease. 
  • Must not have any uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.

Study Requirements

Participants will be randomized into either Group A or Group B. Group A participants will be observed for the first three cycles of the study. Then, they will be given only Bicalutamide. Group B participants will be given the study drug, MK-2206, for the first three cycles. After cycle 3 and beyond, they will be given the MK-2206 with Bicalutamide. All participants in the study will have blood tests, physical exams, and body scans.
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