Surrogacy Case Study: Prostate Specific Antigen (PSA ... - Isped

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Tax 327 mimicking SWOG
Conclusions for HRPC on chemotherapy • Bubley et al (PCWG1, JCO ‘1995) proposed to use a 50% PSA decline as primary endpoints in phase II trials in HRPC Since then most phase II trials used it as primary endpoint in phase II and secondary endpoint in phase III trials • However, despite an apparent strong intraindividual correlation, PSA-response is NOT a surrogate in HRPC, even treated with Docetaxel. • PSA-V or PSA-DT may be better endpoints
Page 1 and 2: EORTC Surrogacy Case Study: Prostat
Page 3 and 4: Prostate Specific Antigen (PSA) •
Page 5 and 6: Transition between clinical states
Page 7 and 8: Surrogate endpoint • An outcome m
Page 9 and 10: Meta-analytic validation First stag
Page 11 and 12: PSA - defined endpoints in prostate
Page 13 and 14: PSA “surrogacy” studies in the
Page 15 and 16: Published PSA surrogacy studies Col
Page 17 and 18: Review • 2 meta-analytic validati
Page 19 and 20: PSA endpoints PSA normalization A P
Page 21 and 22: PSA data (M1) Mean log(PSA) -2 0 2
Page 23 and 24: Treatment effects on OS against tre
Page 25 and 26: Prediction for a new trial - M1 •
Page 27 and 28: PSA doubling-free survival (PSA-D)
Page 29 and 30: Recommendation, M1 hormone sensitiv
Page 31 and 32: 4m vs 24m ADT adjuvant to irradiati
Page 33 and 34: PSA-DT and TTBF surrogate for PCa-s
Page 35 and 36: PSA response or PSA-V surrogate for
Page 37: Of interest… The search for the g
Page 41 and 42: ASCENT trial High dose Calcitriol (
Page 43 and 44: Be aware of your drug’s effect on

Surrogacy Case Study: Prostate Specific Antigen (PSA ... - Isped

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