A Phase II Trial of Arsenic Trioxide in Advanced Hormone-Refractory Prostate Cancer

OBJECTIVES: Determine the efficacy of arsenic trioxide in patients with metastatic stage IVA or IVB hormone-refractory prostate cancer. Determine the toxicity of this drug in this patient population. Assess, in a preliminary manner, the effect of this drug on pain control in these patients. Assess the potential value of serial quantitative prostate-specific antigen (PSA) and prostate-specific membrane antigen (PSMA) mRNA determinations in RNA from peripheral blood mononuclear cells as surrogate markers of disease response in patients treated with this drug. Assess the pharmacokinetics and pharmacodynamics of this drug in these patients. Assess the feasibility of using pretreatment bone marrow evaluation of PSA and PMSA mRNA levels and pi class glutathione S-transferase expression (i.e., eliminate glutathione levels) as potential correlates of disease response in patients treated with this drug. OUTLINE: Patients receive arsenic trioxide IV over 2 hours on days 1-5 and 8-12 for one course. Treatment continues as biweekly infusions for at least 14 additional weeks in the absence of disease progression, unacceptable toxicity, or excessive increase in serum prostate-specific antigen. Pain is assessed at baseline and then before each biweekly treatment. PROJECTED ACCRUAL: A total of 17-37 patients will be accrued for this study within 12-24 months.