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

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Recommendation, M0 and M1 hormone sensitive patients & hormonal treatments • <strong>PSA</strong> does not fully validate as a surrogate endpoint (R²
Recommendation, M1 hormone sensitive patients • Conversely, early marketing authorization might be sought on the basis of documentation very large effects on <strong>PSA</strong> progression (HR
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: PSA doubling-free survival (PSA-D)
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 and 38: Of interest… The search for the g
Page 39 and 40: Conclusions for HRPC on chemotherap
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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