Sunitinib Plus Prednisone In Patients With Metastatic Castration-Resistant Prostate Cancer After Failure Of Docetaxel Chemotherapy

OS is the duration from randomization to death. For participants who were alive, overall survival was censored at the last contact. OS (in months) calculated as (date of death minus \[-\] date of randomization plus \[+\] 1) divided (/) 30.4.

Time frame: Baseline up to 32 months

Population: Full analysis (FA) population: all participants who were randomized, with study drug assignment designated according to initial randomization, regaradless of whether participant received study drug according to the randomization schedule.

EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state (confined to bed). Overall scores range from 0 to 1, with lower scores representing a higher level of dysfunction.

Time frame: Baseline, every 4 weeks up to 123 weeks

Population: Data not summarized, study terminated early

FACT-P is a validated, self-administered instrument used to assess health-related quality of life and prostate cancer-specific symptoms. Scores ranged from 0 (not at all) to 4 (very much). It is 27-item FACT-General and 12 items for the prostate cancer specific concerns. The 27 items in FACT-G are grouped into 4 domains: physical well-being, social/family well-being, emotional well-being and functional well-being. The 12 prostate cancer symptoms items focus on pain (3 items), urination problems (3 items), sexual functions (2 items), weight loss, appetite, overall comfort, and bowel movement.

Time frame: Baseline, every 4 weeks up to 123 weeks

Population: Data not summarized, study terminated early

Pain severity recorded on a numerical scale ranging from 0 (no pain) to 10 (pain as bad as you can imagine). Higher scores indicated greater level of pain. The pain score for each cycle averaged for the 7 days.

Time frame: Day 1 through Day 7 every 28 days (every cycle) up to 29 months

Population: Data not summarized, study terminated early

Time in weeks from the first documentation of objective tumor response to objective tumor progression or death due to any cause. Duration of tumor response was calculated as (the date of the first documentation of objective tumor progression or death due to cause - the date of the first CR or PR that was subsequently confirmed plus 1 divided by 7.02. DR calculated for the subgroup of participants with a confirmed objective tumor response

Time frame: Baseline, every 8 weeks up to 123 weeks

Population: Data not summarized, study terminated early

OR defined as the percent (%) of participants with confirmed Complete Response (CR) (disappearance of all target lesions) or Partial Response (PR) (\>=30% decrease in the sum of the longest dimensions of the target lesions taking as a reference the baseline sum longest dimensions) according to Response Evaluation Criteria in Solid Tumors (RECIST), relative to the full analysis population. Confirmed responses were those that persist on repeat imagining study \>= 4 weeks after initial documentation of response.

Time frame: Baseline, every 8 weeks up to 123 weeks

Population: FA Population

PFS is the period from randomization until disease progression or death on study. PFS is censored on the date of last tumor assessment documenting absence of progressive disease. PFS (weeks) calculated as (first event date - randomization date + 1)/7.02

Time frame: Baseline, every 8 weeks up to 123 weeks

Population: FA Population