Omega-3 Fatty Acids in Treating Patients With Advanced Prostate Cancer

OBJECTIVES:

I. To conduct a pilot study of omega-3 polyunsaturated fatty acid (PUFA) (omega-3 fatty
acid) supplementation in a group of patients with advanced prostate cancer to assess the
dose of omega-3 PUFA necessary to achieve an omega-6 to -3 ratio of 1:1 on an individual
basis and to assess the clinical impact of omega-3 supplementation on disease progression

OUTLINE:

Patients receive long-term omega-3 polyunsaturated fatty acid (PUFA) supplementation orally
(PO).

After completion of study treatment, patients are followed up at 1, 6, and 12 months.

Inclusion Criteria:

Disease is currently controlled with androgen ablation therapy Androgen ablation is
expected to continue for at least 1 year Has been treated with androgen ablation therapy
for at least 1 month Stable or decreasing prostate-specific antigen (PSA) on androgen
ablation therapy Stable or no visible metastatic disease on imaging Eastern Cooperative
Oncology Group (ECOG) functional status of at 0 or 1

Exclusion Criteria:

Eligible for local intervention with surgery or radiation Increasing serum PSA on hormonal
ablation Radiographic evidence of progression of disease on hormonal ablation Current or
history of second malignancy Previously treated with chemotherapeutic agents Previous
history of intermittent androgen therapy Gastrointestinal (GI) disease that impacts
absorption of nutrients