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

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Transition between clinical states of PCa Clinical endpoints take too long shorter endpoints are needed to fasten treatment development Prostatectomy Wait and See Hormones Chemotherapy Irradiation Hormones (Taxotere) Salvage RT Clinically Localized Disease Rising PSA Clinical Metastases: Noncastrate Clinical Metastases: Castrate Death median 8 years 12-25% over 15 years Urology 55:323, 2000 median 3-5 years median 1.5 years
Surrogate endpoint • An outcome measure that is assessed earlier, more frequently or more easily than the final endpoint • That is “reasonably likely” to predict the eventual treatment benefit on the definitive endpoint (survival) (FDA definition) • Requires correlation between treatment effects on the marker and on the true endpoint, across groups of patients • Prostate-specific antigen (PSA) • PSA changes are indicators of disease evolution • 50% PSA decrease (“response”) • PSA increase (“progression”)
Page 1 and 2: EORTC Surrogacy Case Study: Prostat
Page 3 and 4: Prostate Specific Antigen (PSA) •
Page 5: Transition between clinical states
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 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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