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New Trial Designs to Assess Antitumor and Antiproliferative Agents in Prostate Cancer

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Abstract

The discovery of multiple putative therapeutic targets and multipleputative agents for these targets in prostate cancer in the coming yearsposes significant challenges for clinical trial design. This is especiallytrue for cytostatic agents that are not expected to lead to frank tumorshrinkage or declines in the PSA. The most promising agents will need tobe identified early in their development. Since surrogate biologic markersare likely to play a critical role, the identification and validation ofthese markers is discussed. A number of non-traditional phase I and phaseII clinical trial designs, including pre-operative dosing for assessingdrug effect on a marker and the randomized discontinuation phase IIdesign, are also discussed in detail. Use of such designs as well assurrogate marker validation will likely be required to efficiently chooseappropriate agents for definitive study in the phase III setting.

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  1. Sections Hematology/Oncology & Urology, Genitourinary Cancer Program, UC Cancer Research Center, University of Chicago, Chicago, IL, USA

    Walter Stadler

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  1. Walter Stadler
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Stadler, W. New Trial Designs to Assess Antitumor and Antiproliferative Agents in Prostate Cancer. Invest New Drugs 20, 201–208 (2002). https://doi.org/10.1023/A:1015618108456

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