Fenretinide in Treating Patients With Biochemically Recurrent Hormone-Naïve Prostate Cancer

PRIMARY OBJECTIVES: I. To assess the PSA response in prostate cancer patients with only biochemical recurrence after local curative therapy who are then treated with fenretinide (4-HPR). II. To assess PSA doubling time as a measure of disease activity, time to PSA progression in prostate cancer patients receiving fenretinide. III. To evaluate the qualitative and quantitative toxicities of this agent in this patient population. IV. To evaluate pharmacokinetic studies on the bioavailability of 4-HPR in this patient population. OUTLINE: This is a multicenter study. Patients are stratified according to prior therapy (surgery vs radiotherapy and/or brachytherapy vs both), stage at diagnosis (organ confined vs extra-capsular extension vs lymph node positive), Gleason score at diagnosis (2-4 vs 5-6 vs 7-10), and prostate-specific antigen level at diagnosis (0-4 ng/mL vs 4.1-10 ng/mL vs \> 10 ng/mL). Patients receive oral fenretinide twice daily on days 1-7. Courses repeat every 21 days for up to 1 year in the absence of disease progression or unacceptable toxicity.