a study on Prostate Cancer
This study is being done to test an investigational drug called itraconazole in the treatment of prostate cancer.
Hedgehog Inhibition as a Non-Castrating Approach to Hormone Sensitive Prostate Cancer: A Phase II Study of Itraconazole in Biochemical Relapse
This is a phase II, single arm study of itraconazole dosed at 300 mg PO BID in patients with noncastrate, non-metastatic, biochemically relapsed prostate cancer after prior definitive local therapy. Simon's two stage minimax design will be followed for accrual and include an interim test for lack of efficacy. There is a pre-specified stopping rule for safety after 10 patients have been treated for a minimum of 8 weeks of protocol therapy.
Prostate Cancer biochemically relapsed hormone sensitive non-metastatic after prior definitive local therapy PSA Hedgehog-signaling pathway Itraconazole Hydroxyitraconazole
Open to males ages 18 years and up
Minimum PSA: If no prior androgen deprivation therapy (ADT) for biochemical relapse:
Serum testosterone level: If no prior androgen deprivation therapy:
The two most recent measurements of serum testosterone prior to Day 1 of protocol therapy must fulfill the following criteria:
Castrate-resistant disease, as evidenced by either:
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