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

Not Applicable

Withdrawn

• Conditions: Stage III Prostate Cancer
• Interventions: Dietary Supplement: omega-3 fatty acid; Other: bone scan; Other: dual x-ray absorptometry; Other: laboratory biomarker analysis; Procedure: biopsy

• Registration Number: NCT00996749
• Lead Sponsor: Wake Forest University Health Sciences

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.

Study Timeline

• Study First Submitted: 2009-10-15
• Study First Submitted QC: 2009-10-15
• Study First Posted: 2009-10-16
• Study Start: 2011-05
• Primary Completion: 2013-01
• Study Completion: 2013-01
• Status Verified: 2018-07
• Last Update Submitted: 2018-07-02
• Last Update Posted: 2018-07-03

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: Male
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Treatment (omega-3 fatty acid)	laboratory biomarker analysis	Patients receive long-term omega-3 PUFA supplementation PO.
Treatment (omega-3 fatty acid)	biopsy	Patients receive long-term omega-3 PUFA supplementation PO.
Treatment (omega-3 fatty acid)	omega-3 fatty acid	Patients receive long-term omega-3 PUFA supplementation PO.
Treatment (omega-3 fatty acid)	bone scan	Patients receive long-term omega-3 PUFA supplementation PO.
Treatment (omega-3 fatty acid)	dual x-ray absorptometry	Patients receive long-term omega-3 PUFA supplementation PO.

Primary Outcome Measures

Name	Time	Method
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 12 months

Secondary Outcome Measures

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