Conditions: Prostatic Neoplasms
Keywords: Docetaxel-refractory mCRPC Second-line treatment with sunitinib and prednisone
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 873
Healthy volunteers: no

Brief summary:
This study will compare the safety and efficacy of sunitinib in combination with prednisone versus placebo and prednisone in patients that have metastatic castration-resistant prostate cancer that has progressed after treatment with a docetaxel-containing chemotherapy regimen. This is a second-line study.

Detailed description:

Arms:
arm 1: Treatment Arm A - sunitinib + prednisone arm 2: Treatment Arm B - placebo + prednisone

Interventions: intervention 1: Prednisone intervention 2: sunitinib intervention 3: Placebo intervention 4: Prednisone
Intervention descriptions: intervention 1: 5 mg BID, oral intervention 2: 37.5 mg/day, oral, administered on a continuous daily dosing regimen intervention 3: 37.5 mg/day, oral, administered on a continuous daily dosing regimen intervention 4: 5 mg BID, oral

Protocol document: