Gabapentin in Treating Hot Flashes in Patients With Prostate Cancer

OBJECTIVES: * Determine the effectiveness of gabapentin in managing hot flashes in men with prostate cancer. * Determine the response of patients to this drug. * Determine the toxicity of this drug in these patients. * Determine the quality of life of patients treated with this drug. OUTLINE: This is a randomized, double-blind, placebo-controlled, multicenter study. Patients are stratified according to the number of hot flashes per day (2-3 vs 4-9 vs 10 or more) and duration of hot flash symptoms (less than 9 months vs 9 months or more). Patients are randomized to one of four treatment arms. All patients are observed for 7 days prior to drug administration in order to collect baseline hot flash information. * Arm I: Patients receive oral gabapentin once daily on days 1-28. * Arm II: Patients receive oral gabapentin once daily on days 1-7 and twice daily on days 8-28. * Arm III: Patients receive oral gabapentin once daily on days 1-7, twice daily on days 8-14, and three times daily on days 15-28. * Arm IV: Patients receive oral placebo on one of three schedules corresponding to arms I-III. Patients in all arms may continue therapy with gabapentin for an additional 8 weeks. Quality of life is assessed at baseline, day 28, and at the end of the additional 8 weeks. Patients are followed at 6, 12, and 24 months. PROJECTED ACCRUAL: A total of 220 patients (55 per treatment arm) will be accrued for this study within 1 year.