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> endpoints<br />
<strong>PSA</strong> normalization<br />
A <strong>PSA</strong> decline from baseline level (>20 ng/mL)<br />
to ≤ 4 ng/ml at 2 subsequent observations<br />
>4 weeks apart<br />
Time to <strong>PSA</strong> progression-1<br />
Time to <strong>PSA</strong> progression-2<br />
Time to a >20% increase above the nadir<br />
and which exceeded 4 ng/ml (UNL)<br />
Time to an increase >50% above the<br />
(3-)moving average nadir and which exceeded<br />
10 ng/ml (2.5xUNL). This increase had to be<br />
either the last observed value or be sustained for<br />
>4 weeks<br />
Longitudinal <strong>PSA</strong> profile<br />
The complete series of <strong>PSA</strong> measurements in<br />
each patient
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