Design and end points of clinical trials for patients with progressive prostate cancer and castrate levels of testosterone: recommendations of the Prostate Cancer Clinical Trials Working Group

Design and end points of clinical trials for patients with progressive prostate cancer and castrate levels of testosterone: recommendations of the Prostate Cancer Clinical Trials Working Group

Scher HI;Halabi S;Tannock I;Morris M;Sternberg CN;Carducci MA;Eisenberger MA;Higano C;Bubley GJ;Dreicer R;Petrylak D;Kantoff P;Basch E;Kelly WK;Figg WD;Small EJ;Beer TM;Wilding G;Martin A;Hussain M; ;;
journal of clinical oncology : official journal of the american society of clinical oncology 2008 Vol. 26 pp. -
280
hi2008journaldesign

Abstract

PCWG2 recommends increasing emphasis on time-to-event end points (ie, failure to progress) as decision aids in proceeding from phase II to phase III trials. Recommendations will evolve as data are generated on the utility of intermediate end points to predict clinical benefit.

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