Crowdsourcing to Optimize Trial Design in Metformin for Prostate Cancer Study

November 22, 2013
Lisa Henderson
Applied Clinical Trials

Transparency Life Sciences, LLC, and Dr. Matthew Galsky, Associate Professor of Medicine, Division of Hematology/Oncology at the Icahn School of Medicine at Mount Sinai, have collaborated to design and conduct a pilot trial assessing metformin as a potential treatment for prostate cancer.

Related article:The First FDA-Approved Crowdsourced Protocol: An Interview with Tomasz Sablinski, MD, PhD

Transparency Life Sciences, LLC (TLS), and Dr. Matthew Galsky, Associate Professor of Medicine, Division of Hematology/Oncology at the Icahn School of Medicine at Mount Sinai, have collaborated to design and conduct a pilot trial assessing metformin as a potential treatment for prostate cancer. Metformin, widely prescribed for diabetes, has shown promising activity against prostate and other cancers in preclinical and clinical studies.

In a statement, Dr. Galsky said, "One goal of this pilot study is to obtain a preliminary assessment of whether metformin can affect rising prostate specific antigen (PSA) levels in men who have been treated for localized prostate cancer. A second goal is to test whether it is feasible to conduct a cancer trial that incorporates crowdsourcing into the study design and uses telemonitoring to eliminate most patient site visits. Our prior research demonstrates that cancer trials are highly inefficient and geographically inaccessible to a large proportion of cancer patients. We are optimistic that a greater number of patients would participate if they were more engaged in the process and the burden of site visits were reduced."

To that end, the study will use TLS Protocol Builder, its online crowdsourcing tool that elicits input from patients, physicians and researchers to help design clinical trials. It will also add the telemonitoring aspect through TLS' tele health partner AMC Health in the metformin study.

You can read the full release here.