39
Participants
Start Date
March 28, 2018
Primary Completion Date
December 22, 2022
Study Completion Date
December 22, 2022
Apalutamide
240mg tablet daily for 36 weeks
Androgen deprivation
ADT will consist of treatment with a GnRH agonist or antagonist per physician and institutional preference. Either leuprolide acetate (Lupron Depot, 22.5 mg or 45 mg IM), triptorelin pamoate (Trelstar, 11.25 mg or 22.5 mg IM), goserelin acetate (Zoladex, 10.8mg SC) or degarelix (Firmagon 120 mg or 240 mg SC) will be administered monthly, every 3 months, or every 6 months, depending on institutional standards, for 36 weeks total.
Salvage radiation therapy
On week 9 (+/- 28 days), subjects will begin salvage radiation therapy to the prostate bed. The total dose to the prostate bed must be 66-74 Gy in 1.8-2 Gy daily fractions over a total of 6-8 weeks
Docetaxel
About 4 weeks (+/- 2 weeks, pending recovery of adverse events from radiation to Grade 2 or less) after completing radiation, patients will start docetaxel 75mg/m2 intravenously, every 3 weeks for 6 cycles.
Weill Cornell Medical Center, New York
Wake Forest Univesity, Winston-Salem
Duke Cancer Center Cary, Cary
Duke University Medical Center, Durham
GU Research Network / Urology Cancer Center, Omaha
Andrew J. Armstrong, MD
OTHER