Stage III Prostate Cancer
Conditions
Brief summary
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
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.
Interventions
DIETARY_SUPPLEMENTomega-3 fatty acid
Given PO
OTHERbone scan
Correlative studies
Correlative studies
OTHERlaboratory biomarker analysis
Correlative studies
PROCEDUREbiopsy
Correlative studies
Sponsors
National Cancer Institute (NCI)
Wake Forest University Health Sciences
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | 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 |
Secondary
| Measure | Time frame |
|---|---|
| Bone density as assessed by dual energy x-ray absorptiometry (DEXA) scan | At baseline |
| Time to PSA progression | At 1 year |
| Bone density as assessed by DEXA scan | At 1 year |
| Rates of PSA progression | At 1 year |
| Status of bony metastasis | At baseline |
Outcome results
None listed