Not provided
Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2009-01340 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| CCCWFU 85108 | Other Identifier | Wake Forest University Health Sciences |
Not provided
Not provided
Not provided
No Participants enrolled; slow accrual
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
Not provided
Not provided
Not provided
Not provided
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
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment (omega-3 fatty acid) | Experimental | Patients receive long-term omega-3 PUFA supplementation PO. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| omega-3 fatty acid | Dietary Supplement | Given PO |
|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Time to PSA progression | At 1 year | |
| Rates of PSA progression | At 1 year | |
| Status of bony metastasis |
Not provided
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
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Majid Mirzazadeh | Wake Forest University Health Sciences | Principal Investigator |
Not provided
| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
Not provided
Not provided
| ID | Term |
|---|---|
| D015525 | Fatty Acids, Omega-3 |
| D005395 | Fish Oils |
| D015502 | Absorptiometry, Photon |
| D001706 | Biopsy |
| ID | Term |
|---|---|
| D004042 | Dietary Fats, Unsaturated |
| D004041 | Dietary Fats |
| D005223 | Fats |
| D008055 | Lipids |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| bone scan | Other | Correlative studies |
|
| dual x-ray absorptometry | Other | Correlative studies |
|
|
| laboratory biomarker analysis | Other | Correlative studies |
|
| biopsy | Procedure | Correlative studies |
|
|
| 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 |
| D005832 |
| Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
| D005231 |
| Fatty Acids, Unsaturated |
| D005227 | Fatty Acids |
| D009821 | Oils |
| D011859 | Radiography |
| D003952 | Diagnostic Imaging |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D003720 | Densitometry |
| D010783 | Photometry |
| D002623 | Chemistry Techniques, Analytical |
| D008919 | Investigative Techniques |
| D003581 | Cytodiagnosis |
| D003584 | Cytological Techniques |
| D019411 | Clinical Laboratory Techniques |
| D013048 | Specimen Handling |
| D003949 | Diagnostic Techniques, Surgical |
| D013514 | Surgical Procedures, Operative |