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Table 8 Randomized Controlled Trials of Glucocorticoids in Prostate Cancer

From: Systematic review of the clinical effect of glucocorticoids on nonhematologic malignancy

Author [reference], Year

Patient Characteristics

Treatment Arms

Patient Number (Randomized/Evaluable)

Quality Score

Outcome(s)

Sander et al [43], 1982

Advanced untreated prostate cancer

orchiectomy (7/7) vs. ochiectomy + prednisone 2.5 mg po four times daily for 6 weeks (14/14) vs. ochiectomy + cyproterone acetate 50 mg po four times daily for 6 weeks (13/13)

1

response rates of 86% vs. 93% vs. 62%

Williams et al [59], 1990

Advanced untreated prostate cancer

orchiectomy (24/24) vs. orchiectomy + dexamethasone 0.5 mg in morning and 0.3 mg at night (16/16) vs. orchiectomy + cyproterone acetate 100 mg 3 times daily (20/20)

3

response rates of 33% vs. 62.5% vs. 45% at 1 year

Fossa et al [33], 1985

Hormone refractory prostate cancer

MPA 500 mg po twice daily (24/21) vs. prednisolone 5 mg po four times daily (24/24)

2

response rates of 38% vs. 13% (p < 0.05), no survival difference

Patel et al [8], 1990

Hormone refractory metastatic prostate cancer

Megestrol acetate 40 mg po four times daily (29/25) vs. dexamethasone 0.75 mg po twice daily (29/26), Treatment until PD

2

response rates of 10% vs. 7%, median survival of 268 vs. 246 days (p = 0.2)

Datta et al [35], 1997

Hormone refractory metastatic prostate cancer

Flutamide 250 mg three times daily (20/20) vs. prednisolone 5 mg twice daily (20/20)

2

PSA response rates of 50% vs. 55%, median survival of 30 vs. 36 weeks (p > 0.05)

Tyrrell [36, 54, 60], 1996

Hormone refractory advanced prostate cancer

prednisone 10 mg po twice daily (103/NR) vs. liarozole 300 mg po twice daily (117/NR)

1

PSA response rates of 25% vs. 18% (p = 0.31); time to PSA progression of 4.7 vs. 3.5 months; median survivals of 15.8 months vs. 11.7 months (p = 0.01)

Fossa et al [32], 2001

Hormone refractory metastatic prostate cancer

prednisone 5 mg po four times a day (101/95) vs. flutamide 250 mg po three times a day (100/96); treatment until PD

2

PSA responses of 21% vs. 23%, median time to progression of 3.4 months vs. 2.3 months (p = 0.0885); overall survival of 10.6 months vs. 11.2 months (p = 0.8370)

Tombal et al [50], 2003

Hormone refractory metastatic prostate cancer

irofulven (24 mg/m2 for first 18 patients then 0.55 mg/kg for next 43 patients) IV days 1 and 15 q4 weeks (29/28) vs. same + prednisone 10 mg daily (32/28)

1

PSA responses of 3/28 vs. 5/28