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

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4m vs 24m ADT adjuvant to irradiation of locally advanced PCa (RTOG 92-02) • PSA-DT estimated based on minimum 3 measurements (ASTRO definition of PSA failure) • Median follow-up 5.9 years • PSA-DT
PSA-DT and TTBF surrogate for PCa-specific survival after RT+ADT? TROG 96.01 Locally advanced PCa R RT alone RT + 3 months ADT RT + 6 months ADT PC- Death • PSADT ≤ 12 m and ≤ 15 m satisfied all Prentice criteria (PTE of 0.36 a 0.56 resp) • TTBF ≤ 1.5, 2 or 2.5 y satisfied all Prentice criteria (PTE between 0.45 & 0.64) ?!?? Ref: Denham JW et al. Lancet 2008
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: 4m vs 24m ADT adjuvant to irradiati
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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