Novel trial designs: which agents and how do we test them?

Over the last decade, an increasing number of novel therapies have been tested in prostate cancer. Although each agent has potential to affect the natural history of the disease, how we should proceed, select, and test these agents to show a clinical benefit remains a dilemma. Because prostate cancer is a heterogeneous disease, an understanding of the disease states is required to screen and test novel agents. Only with the appropriate selection of disease state, trial design, and endpoints will we be able to select the most promising regimens to move forward. [Copyright &y& Elsevier]