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

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Prostate Specific Antigen (PSA) • PSA is prostate-specific but not cancer specific. • PSA is androgen dependent. • Different therapies may have different effects on PSA expression. • Prostate cancer is a heterogeneous disease: not all prostate cancer express PSA at the same level (eg: lower expression in poorly differentiated cancer) • Increases of PSA levels may be induced by • Prostatitis (infection) • BPH • Manipulations: prostate biopsy, TUR • Stones • Ejaculation • Specificity is low!
Transition between clinical states of PCa 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
Page 1 and 2: EORTC Surrogacy Case Study: Prostat
Page 3: Prostate Specific Antigen (PSA) •
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 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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