Prostate Cancer Clinical Trial
Official title:
A Phase II Trial of RAD001 and Bicalutamide for Androgen Independent Prostate Cancer
In the treatment of castration-resistant prostate cancer (CRPC), therapies will long response durations remain elusive as a result of the inherent ability of prostate cancer cells to develop iterative resistance. The goal of this study is to learn if the study drug RAD001 together with Bicalutamide can slow the growth of prostate cancer. The safety of the combination will also be studied.
Bicalutamide, an androgen receptor (AR) antagonist, is frequently used as the first
'secondary hormonal therapy' in combination with another established agent (LHRH: luteinizing
hormone-releasing hormone agonist/antagonist) to treat CRPC. A series of studies have shown
that RAD001 through inhibition of mammalian target of rapamycin (mTOR) pathway has antitumor
and anti-angiogenic activities. The hypothesis is that the combination of an antiandrogen and
mTOR inhibitor would have additive and clinically significant effects in CRPC.
STATISTICAL CONSIDERATIONS:
The regimen will be considered promising if the rate of response/favorable outcome is 40% or
greater. A rate of 20% (similar to that observed for bicalutamide alone) will not be
considered worthy of further study. 38 patients (of whom 36 are assumed to be eligible) will
be accrued to the study. If 11 or more patients have a favorable outcome (stable disease > 6
months or response), the combination will be considered worthy of further study. Given this
design, there is a 9% probability of declaring the combination effective if the true
favorable outcome rate is 20% and a 91% probability of declaring the combination effective if
the true favorable outcome rate is 40%.
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