Novel strategies to test biological hypotheses in early drug development for advanced prostate cancer

R Ferraldeschi, G Attard, JS de Bono - Clinical chemistry, 2013 - academic.oup.com
R Ferraldeschi, G Attard, JS de Bono
Clinical chemistry, 2013academic.oup.com
BACKGROUND Major advances in our understanding of the underlying biology of prostate
cancer have helped to herald a new era in the treatment of castration-resistant prostate
cancer (CRPC), with 5 new agents having shown a survival advantage in the last 3 years
and an impressive number of promising novel agents now entering the clinic. CONTENT We
discuss the challenges facing drug development for CRPC and strategies to meet these
challenges, with a focus not only on the development of predictive and intermediate …
BACKGROUND
Major advances in our understanding of the underlying biology of prostate cancer have helped to herald a new era in the treatment of castration-resistant prostate cancer (CRPC), with 5 new agents having shown a survival advantage in the last 3 years and an impressive number of promising novel agents now entering the clinic.
CONTENT
We discuss the challenges facing drug development for CRPC and strategies to meet these challenges, with a focus not only on the development of predictive and intermediate endpoint biomarkers, but also on novel hypothesis-testing, biomarker-driven clinical trial designs.
SUMMARY
With several promising agents now entering the clinic, there is increasing pressure to rethink drug development for CRPC to ensure that novel agents are appropriately evaluated and that patients and resources are appropriately allocated. We envision that biomarker-driven, reiterative clinical trials will have a major impact on CRPC treatment through the testing of robust scientific hypotheses with rationally designed drugs and drug combinations administered to selected patients.
Oxford University Press
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