NCT00996749

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

Trial Health

15
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started May 2011

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 15, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 16, 2009

Completed
1.5 years until next milestone

Study Start

First participant enrolled

May 1, 2011

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2013

Completed
Last Updated

July 3, 2018

Status Verified

July 1, 2018

Enrollment Period

1.7 years

First QC Date

October 15, 2009

Last Update Submit

July 2, 2018

Conditions

Stage III Prostate Cancer

Outcome Measures

Primary Outcomes (5)

  • 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 Outcomes (5)

  • 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

Study Arms (1)

Treatment (omega-3 fatty acid)

EXPERIMENTAL

Patients receive long-term omega-3 PUFA supplementation PO.

Dietary Supplement: omega-3 fatty acidOther: bone scanOther: dual x-ray absorptometryOther: laboratory biomarker analysisProcedure: biopsy

Interventions

omega-3 fatty acidDIETARY_SUPPLEMENT

Given PO

Also known as: fish oil, n-3 fatty acid, O3FA
Treatment (omega-3 fatty acid)
bone scanOTHER

Correlative studies

Treatment (omega-3 fatty acid)
dual x-ray absorptometryOTHER

Correlative studies

Also known as: DEXA scan, dual energy x-ray absorptometry
Treatment (omega-3 fatty acid)
laboratory biomarker analysisOTHER

Correlative studies

Treatment (omega-3 fatty acid)
biopsyPROCEDURE

Correlative studies

Also known as: biopsies
Treatment (omega-3 fatty acid)

Eligibility Criteria

Age18 Years+
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Fatty Acids, Omega-3Fish OilsAbsorptiometry, PhotonBiopsy

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

Dietary Fats, UnsaturatedDietary FatsFatsLipidsFatty Acids, UnsaturatedFatty AcidsOilsRadiographyDiagnostic ImagingDiagnostic Techniques and ProceduresDiagnosisDensitometryPhotometryChemistry Techniques, AnalyticalInvestigative TechniquesCytodiagnosisCytological TechniquesClinical Laboratory TechniquesSpecimen HandlingDiagnostic Techniques, SurgicalSurgical Procedures, Operative

Study Officials

  • Majid Mirzazadeh

    Wake Forest University Health Sciences

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 15, 2009

First Posted

October 16, 2009

Study Start

May 1, 2011

Primary Completion

January 1, 2013

Study Completion

January 1, 2013

Last Updated

July 3, 2018

Record last verified: 2018-07