20756
document
Phase III trial of satraplatin , an oral platinum plus prednisone vs. prednisone alone in patients with hormone-refractory prostate cancer . Satraplatin is a novel oral platinum ( IV ) complex that shows activity against hormone-refractory prostate cancer ( HRPC ) in cisplatin-resistant human tumor lines in phase I and phase II trials . A randomized multicenter phase III trial with a target sample size of 380 patients was initiated in men with HRPC . After 50 randomized patients , the trial was closed to further accrual by the sponsoring company . An ad hoc analysis of all available data is reported here . Eligibility criteria included pathological proof of prostate cancer , documented progression despite prior hormonal manipulation , WHO PS 0-2 , and no daily intake of narcotic analgesics . Patients were randomized between satraplatin 100 mg/m ( 2 ) for 5 days plus prednisone 10 mg orally BID or prednisone alone . Compliance was excellent . 48/50 patients have progressed and 42 have died , mostly due to prostate cancer . Median overall survival was 14.9 months ( 95 % CI : 13.7-28.4 ) on the satraplatin plus prednisone arm and 11.9 months ( 95 % CI : 8.4-23.1 ) on prednisone alone ( hazard ratio , HR = 0.84 , 95 % CI : 0.46-1.55 ) . A > 50 % decrease in prostrate specific antigen ( PSA ) was seen in 9/27 ( 33.3 % ) in the satraplatin plus prednisone arm vs. 2/23 ( 8.7 % ) on the prednisone alone arm . Progression-free survival was 5.2 months ( 95 % CI : 2.8-13.7 ) on the satraplatin plus prednisone arm as compared to 2.5 months ( 95 % CI : 2.1- 4.7 ) on the prednisone alone arm ( HR = 0.50 , 95 % CI : 0.28-0.92 ) . This difference is statistically significant ( p = 0.023 ) . Toxicity was generally minimal in both arms . This randomized comparison of a combination of satraplatin and prednisone versus prednisone alone supports the antitumor activity of the combination . Its role in the treatment of HPRC remains to be elucidated in an appropriate phase III setting .
20757
Intervention_Pharmacological
satraplatin
20758
Intervention_Pharmacological
platinum plus prednisone
20759
Intervention_Pharmacological
prednisone alone
20760
Intervention_Pharmacological
Satraplatin
20761
Intervention_Pharmacological
platinum
20762
Intervention_Pharmacological
cisplatin-resistant
20763
Intervention_Pharmacological
narcotic analgesics
20764
Intervention_Pharmacological
satraplatin
20765
Intervention_Pharmacological
prednisone
20766
Intervention_Control
prednisone
20767
Intervention_Pharmacological
satraplatin
20768
Intervention_Pharmacological
prednisone
20769
Intervention_Pharmacological
prednisone
20770
Intervention_Pharmacological
satraplatin plus prednisone
20771
Intervention_Pharmacological
prednisone
20772
Intervention_Pharmacological
satraplatin
20773
Intervention_Pharmacological
prednisone
20774
Intervention_Pharmacological
prednisone
20775
Intervention_Pharmacological
satraplatin
20776
Intervention_Pharmacological
prednisone
20777
Outcome_Physical
progressed
20778
Outcome_Mortality
died
20779
Outcome_Mortality
Median overall survival
20780
Outcome_Physical
prostrate specific antigen
20781
Outcome_Mortality
Progression-free survival
20782
Outcome_Physical
Toxicity
20783
Participant_Condition
patients with hormone-refractory prostate cancer .
20784
Participant_Condition
hormone-refractory prostate cancer ( HRPC )
20785
Participant_Sample-size
380
20786
Participant_Age
men
20787
Participant_Condition
HRPC .
20788
Participant_Sample-size
50
20789
Participant_Condition
prostate cancer