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Atrasentan, an epidermal growth factor
inhibitor. (November 2002)
A pair of PHASE III studies comparing 10
mg oral Atrasentan versus placebo in men with hormone refractory PC have
been conducted nationwide. The study for men with metastatic disease is
now closed after accruing more then 1000 participants.
The study for PC patients with non-metastatic disease is open and
currently has accrued over 700 patients nationwide. The study design is
double blinded and compares 10 mg Atrasentan with placebo. Patients may
have had either a radical prostatectomy or primary irradiation and must
demonstrate a rising PSA while on hormone therapy. Eligibility requires a
negative bone scan and CT scan. The PSA must be >1 ng/ml and exhibit three
consecutive rises at no less than 2-week intervals. A PSA of >20 by itself
is sufficient for entry. Bone scans are repeated at 12-week intervals and
newly developed positivity ends the study for that patient. A rising PSA
during the study is NOT a reason for study termination. Patients who fail
on the placebo arm may then receive Atrasentan.
Questions about entering patients into the study should be directed to
Laura Hopper at 215-3373.
Bottom Line: This protocol fits into a commonly encountered niche in which
there is no standard treatment.
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