Conditions: Prostate Cancer Castration Resistant Prostate Cancer Pain Prostatic Neoplasms
Keywords: prostate cancer castration resistant prostate cancer bone pain CRPC
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 1028
Healthy volunteers: no

Brief summary:
This study will evaluate the effect of cabozantinib compared to prednisone on overall survival in men with previously treated metastatic castration-resistant prostate cancer with bone-dominant disease who have experienced disease progression on docetaxel-containing chemotherapy and abiraterone or MDV3100.

Detailed description:

Arms:
arm 1: Subjects randomized to the cabozantinib arm will also receive placebo-matched prednisone capsules. arm 2: Subjects randomized to the prednisone arm will also receive placebo-matched cabozantinib.

Interventions: intervention 1: cabozantinib intervention 2: prednisone
Intervention descriptions: intervention 1: Tablets taken orally once-daily intervention 2: Taken twice a day orally. Commercially-obtained prednisone tablets will be over-encapsulated in order to blind identity.

Protocol document: