Enrollment Completed for Phase 3 Trial Testing Provenge in Prostate Cancer Patients on Active Surveillance

Enrollment Completed for Phase 3 Trial Testing Provenge in Prostate Cancer Patients on Active Surveillance
Dendreon Pharmaceuticals has completed patient enrollment ahead of schedule in an ongoing Phase 3 trial assessing the safety and efficacy of its immunotherapy Provenge (sipuleucel-T) for men with early-stage prostate cancer on active surveillance, the company announced. The open-label ProVent trial (NCT03686683) included more than 450 participants from approximately 60 sites across the United States. Patients were randomly assigned to one of two groups: those who continued on active surveillance as standard of care (control group), and those given three infusions of Provenge at approximately two-week intervals. “The rapid pace of enrollment in the ProVent trial is a significant milestone for Dendreon, and underscores a strong interest by patients and physicians in the potential clinical benefit of sipuleucel-T in men on active surveillance,” Bruce A. Brown, MD, chief medical officer at Dendreon, said in a press release. Prostate cancer is the most common cancer among men, but a great number of cases will remain dormant and not progress to significant disability or risk of mortality. In these cases, active surveillance — an approach that consists of actively monitoring the cancer to detect progression before starting any treatment — is an accepted alternative to treatments that can carry significant side effects. Data from large academic institutions and clinical trials have shown that active surveillance is safe and results in low rates of cancer-specific mortality. However, some patients will eventually progress and require radical treatments, such as surgery and radiation. Provenge is an immunotherapy that uses a patient’s own immune cells to fight prostate cancer. It consists of a fraction of white blood cells that have been exposed to a pros
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