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

Study Overview
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Brief Summary
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This phase I trial is studying the best way to give omega-3 fatty acids in treating patients with advanced prostate cancer. Omega-3 fatty acids may slow disease progression and may be an effective treatment for patients with advanced prostate cancer

Detailed Description
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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.

Official Title
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Pilot Study to Determine the Optimal Dosage of Omega-3 Polyunsaturated Fatty Acid (PUFA) in Men With Advanced Prostate Cancer

Conditions
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Stage III Prostate Cancer

Intervention / Treatment
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* Dietary Supplement: omega-3 fatty acid
* Other: bone scan
* Other: dual x-ray absorptometry
* Other: laboratory biomarker analysis
* Procedure: biopsy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment (omega-3 fatty acid)<br>Patients receive long-term omega-3 PUFA supplementation PO. | Dietary Supplement: omega-3 fatty acid<br>* Given PO<br>* Other names: O3FA;Other: bone scan<br>* Correlative studies<br>Other: dual x-ray absorptometry<br>* Correlative studies<br>* Other names: dual energy x-ray absorptometry;Other: laboratory biomarker analysis<br>* Correlative studies<br>Procedure: biopsy<br>* Correlative studies<br>* Other names: biopsies;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Omega-3 fatty acid levels in serum and fat biopsies |  | At 1 year | 
| Omega-6 fatty acid levels in serum and fat biopsies |  | At 1 year | 
| Tolerability of omega-3 fatty acid supplementation |  | At 1 month | 
| Tolerability of omega-3 fatty acid supplementation |  | At 6 months | 
| Tolerability of omega-3 fatty acid supplementation |  | At 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to PSA progression |  | At 1 year | 
| Rates of PSA progression |  | At 1 year | 
| Status of bony metastasis |  | At baseline | 
| Bone density as assessed by dual energy x-ray absorptiometry (DEXA) scan |  | At baseline | 
| Bone density as assessed by DEXA scan |  | At 1 year |