Surrogacy Case Study: Prostate Specific Antigen (PSA ... - Isped
Surrogacy Case Study: Prostate Specific Antigen (PSA ... - Isped
Surrogacy Case Study: Prostate Specific Antigen (PSA ... - Isped
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<strong>PSA</strong> surrogate endpoint in M1<br />
prostate cancer?<br />
Bicalutamide (‘Casodex’)<br />
50 mg versus castration 1<br />
(n=530)<br />
Bicalutamide 100/150 mg<br />
versus castration 2,3<br />
(n=870)<br />
N=2161<br />
M1 (D2)<br />
WHO PS: 0-2<br />
Age: 71 years<br />
<strong>PSA</strong>: 200 ng/ml<br />
META<br />
ANALYTIC<br />
VALIDATION<br />
Bicalutamide 50 mg +<br />
castration versus<br />
flutamide + castration 4<br />
(n=761)<br />
Unit: by study and country<br />
1<br />
Iversen et al. Scand J Urol Nephrol 1996; 30: 93-98<br />
2<br />
Kaisary et al. Eur Urol 1995; 28: 215-222; 3 Tyrrell et al. Eur Urol 1998; 33: 447-456<br />
4<br />
Schellhammer et al. Urology 1995; 45: 745-752
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