20
Participants
Start Date
September 22, 2011
Primary Completion Date
July 21, 2015
Study Completion Date
July 21, 2020
Cabazitaxel
"Administered weekly on the same day of radiation according to the following infusion levels:~Level 1 (Initial): 4 mg/m2; Level -1: 2 mg/m2; Level 2: 6 mg/m2; Level 3: 8 mg/m2; Level 4: 10 mg/2;"
Intensity Modulated Radiation Therapy (IMRT)
Starts 8 weeks after initiation of androgen deprivation therapy, given daily at 1.8 Gy for a total of 75.6 Gy
Anti-Androgen Therapy: Bicalutamide
"* Taken once daily by mouth starting between 2 weeks and 1 day before the first administration of Luteinizing Hormone-Releasing Hormone (LHRH)~* Will continue once daily until the final day of IMRT"
Luteinizing Hormone-Releasing Hormone (LHRH) Agonist
"* First administration will occur 1 day to 2 weeks after the start of Bicalutamide and 8 weeks prior to the start of IMRT (+/- 4 weeks)~* Will continue for 24 months after IMRT~* Total administered duration and agent used must be documented on the case report form"
Thomas Jefferson University, Philadelphia
Collaborators (1)
Sanofi
INDUSTRY
Sidney Kimmel Cancer Center at Thomas Jefferson University
OTHER