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news.The FDA has informed GTx, a men's health focused biotech company, of its recommendations for the design of the company's pivotal phase III clinical trial of Acapodene for the prevention of prostate cancer in high-risk men.
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The FDA recommendations were made under the special protocol assessment (SPA), a process in which the FDA evaluates phase III clinical trials and gives assurances that the design of the study is adequate to support a new drug application.
GTx says that it will implement the FDA’s recommendations made under the SPA, which the company expects will be sufficient to support the submission of the effectiveness portion of a new drug application.
The pivotal phase III trial is a study of 1,260 patients who will receive daily either an oral 20 mg dose of Acapodene or placebo. The primary endpoint of the trial is a reduction in prostate cancer incidence as determined by prostate biopsy.
The statistical assumptions for the design of this phase III trial are based on the positive results of the phase IIb high grade PIN trial in 514 patients completed in June 2004.