Last updated on November 2018

Randomized Controlled Trial of ProstAtak Immunotherapy During Active Surveillance for Prostate Cancer (ULYSSES)

Brief description of study

The purpose of this study is to evaluate the effectiveness of ProstAtak immunotherapy in patients undergoing active surveillance for localized prostate cancer. ProstAtak involves the use of aglatimagene besadenovec (AdV-tk) to kill tumor cells and stimulate a cancer vaccine effect. Killing tumor cells in an immune stimulatory environment induces the body's immune system to detect and destroy cancer cells. ProstAtak has been well tolerated in previous trials in patients with prostate cancer and other tumor types. Biochemical, pathologic and immune responses have been demonstrated in newly diagnosed and recurrent prostate cancer. The hypothesis is that ProstAtak can lead to improvement in the clinical outcome for patients with prostate cancer. Participants will be randomized to the ProstAtak or control arm at a 2:1 ratio. Both arms receive standard of care active surveillance evaluations.

Clinical Study Identifier: NCT02768363

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Eric J. Margolis, MD

Urologic Research and Consulting LLC / New Jersey Urology
Englewood, NJ United States
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Shawn H Zimberg, MD

Advanced Radiation Centers of New York (Integrated Medical Professionals)
Bronx, NY United States
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Recruitment Status: Open

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