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

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ASCENT trial High dose Calcitriol (DN-101) + Docetaxel vs Placebo + Docetaxel • 250 men with M1 HRPC randomized to • Primary endpoint: PSA response (first 6 months defined as 50% decline) • Secondary endpoint: Overall survival, PSA progression-free survival R Docetaxel + Placebo Docetaxel + DN-101 Ref. Beer TM et al, JCO 2007
ASCENT trial High dose Calcitriol (DN-101) + Docetaxel vs Placebo + Docetaxel • Results: DN-101 Placebo P-value PSA response 58% 49% 0.16 PSA-PFS 7.9 m 7.6 m 0.7 Overall survival 24.5m 16.4 m P=0.04 HR=0.67 Ref. Beer TM et al, JCO 2007
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 and 38: Of interest… The search for the g
Page 39: Conclusions for HRPC on chemotherap
Page 43 and 44: Be aware of your drug’s effect on

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

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