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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Conclusions for HRPC on<br />
chemotherapy<br />
• Bubley et al (PCWG1, JCO ‘1995) proposed to use<br />
a 50% <strong>PSA</strong> decline as primary endpoints in phase<br />
II trials in HRPC Since then most phase II trials<br />
used it as primary endpoint in phase II and<br />
secondary endpoint in phase III trials<br />
• However, despite an apparent strong intraindividual<br />
correlation, <strong>PSA</strong>-response is NOT a<br />
surrogate in HRPC, even treated with Docetaxel.<br />
• <strong>PSA</strong>-V or <strong>PSA</strong>-DT may be better endpoints
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