HCRN study combines bone-targeting drug with androgen deprivation therapy for metastatic prostate cancer
Hoosier Cancer Research Network (HCRN) announces the launch of a cancer clinical trial for subjects with newly diagnosed metastatic prostate cancer with bone metastases.
The study, known as GU13-170, will compare the good and bad effects of adding Radium-223 dichloride, a bone-targeted drug, to androgen deprivation therapy, the usual treatment for this type of cancer.
The study is now open to accrual at the University of Michigan Comprehensive Cancer Center. Subjects who enroll on this study will be randomized by chance to one of two groups. The first group, called Arm A, will receive androgen deprivation therapy with bicalutamide. This is the usual treatment. The second group, called Arm B, will receive androgen deprivation therapy with bicalutamide plus the study drug, Radium-223 dichloride.
Radium-223 dichloride is already FDA-approved for use in metastatic prostate cancer that has become resistant to androgen deprivation therapy and has spread to the bone. It is not known at this time whether adding Radium-223 dichloride to androgen deprivation therapy could benefit patients. This study will help researchers to know whether this experimental approach is better, the same, or worse than the usual approach.
The standard treatment for prostate cancer has long involved hormone therapy. According to the study’s sponsor-investigator, Ajjai Alva, MD, of the University of Michigan, Radium-223 dichloride builds on the backbone of hormone therapy by targeting the bones, a common site of metastasis in prostate cancer.
“Since 85 percent of metastatic prostate cancer goes to the bones, radium is going to where the problem is,” he said. “We believe that combining hormone therapy with radium will focus the treatment more specifically to the involved areas of the body, and will also offer patients the benefit of radium sooner.”
To be eligible, subjects must have metastatic prostate cancer with bone metastases. This means the cancer has spread outside the prostate and has been detected in the bone. Other criteria must be met to be eligible for this study.
See clinicaltrials.gov (study #NCT02582749) for more information about this trial, including full eligibility requirements.
About Hoosier Cancer Research Network:
Hoosier Cancer Research Network (formerly known as Hoosier Oncology Group) conducts innovative cancer research in collaboration with academic and community physicians and scientists across the United States. The organization provides comprehensive clinical trial management and support, from conception through publication. Created in 1984 as a program of the Walther Cancer Institute, Hoosier Cancer Research Network became an independent nonprofit clinical research organization in 2007. Since its founding, Hoosier Cancer Research Network has initiated more than 150 trials in a variety of cancer types and supportive care, resulting in more than 300 publications. More than 4,600 subjects have participated in Hoosier Cancer Research Network clinical trials.
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