Sipuleucel-T With or Without Radiation Therapy in Treating Patients With Hormone-Resistant Metastatic Prostate Cancer

Summary

This randomized phase II trial studies how well giving sipuleucel-T with or without radiation therapy works in treating patients with hormone-resistant metastatic prostate cancer. Vaccines may help the body build an effective immune response to kill tumor cells. Radiation therapy uses high energy x rays to kill tumor cells. It is not yet known whether giving sipuleucel-T vaccine is more effective with or without radiation therapy in treating prostate cancer

Timeline

Start

2013-06-25

Primary completion

2018-12-31

Completion

2019-12-31

Outcome

Missed primary endpoint

registry MEDIAN Arm A (Sipuleucel-T): 2.46 (2.17 to 2.66) Months MEDIAN Arm B (Radiation Therapy, Sipuleucel-T): 3.65 (2.76 to 4.86) Months NCT01807065 ↗

registry analysis (other test); Arm A (Sipuleucel-T) vs Arm B (Radiation Therapy, Sipuleucel-T); p = 0.06; Log Rank NCT01807065 ↗

Publications

• Twardowski P, Wong JYC, Pal SK, Maughan BL, Frankel PH, Franklin K, Junqueira M, Prajapati MR, Nachaegari G, Harwood D, Agarwal N. Randomized phase II trial of sipuleucel-T immunotherapy preceded by sensitizing radiation therapy and sipuleucel-T alone in patients with metastatic castrate resistant prostate cancer. Cancer Treat Res Commun. 2019;19:100116. doi: 10.1016/j.ctarc.2018.100116. Epub 2018 Dec 20.

Drugs

Indications