Stage III Prostate CancerNCT00996749
Omega-3 Fatty Acids in Treating Patients With Advanced Prostate Cancer
A study testing omega-3 fatty acid, bone scan and dual x-ray absorptometry in people with Stage III Prostate Cancer, run by Wake Forest University Health Sciences.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Stage III Prostate Cancer
- What is being tested?
- omega-3 fatty acid, bone scan and dual x-ray absorptometry
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- May 2011to Jan 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
About this study
Official title: Pilot Study to Determine the Optimal Dosage of Omega-3 Polyunsaturated Fatty Acid (PUFA) in Men With Advanced Prostate Cancer
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
Read the detailed description
OBJECTIVES:
- 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.
- Conditions
- Stage III Prostate Cancer
- Being tested
- omega-3 fatty acid, bone scan, dual x-ray absorptometry, laboratory biomarker analysis, biopsy
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
omega-3 fatty acidDietary supplement
Also called fish oil, n-3 fatty acid, O3FA
Given PO
bone scanOther
Correlative studies
dual x-ray absorptometryOther
Also called DEXA scan, dual energy x-ray absorptometry
Correlative studies
laboratory biomarker analysisOther
Correlative studies
biopsyProcedure or surgery
Also called biopsies
Correlative studies
| Study group | Role | What they receive |
|---|---|---|
| Treatment (omega-3 fatty acid) | Experimental | Patients receive long-term omega-3 PUFA supplementation PO. Receives: Dietary Supplement: omega-3 fatty acid; Other: bone scan; Other: dual x-ray absorptometry; Other: laboratory biomarker analysis; Procedure: biopsy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Omega-3 fatty acid levels in serum and fat biopsies
Measured: At 1 year
Omega-6 fatty acid levels in serum and fat biopsies
Measured: At 1 year
Tolerability of omega-3 fatty acid supplementation
Measured: At 1 month
Tolerability of omega-3 fatty acid supplementation
Measured: At 6 months
Tolerability of omega-3 fatty acid supplementation
Measured: At 12 months
Secondary outcomes (5)
Time to PSA progression
Measured: At 1 year
Rates of PSA progression
Measured: At 1 year
Status of bony metastasis
Measured: At baseline
Bone density as assessed by dual energy x-ray absorptiometry (DEXA) scan
Measured: At baseline
Bone density as assessed by DEXA scan
Measured: At 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2009 (estimated)
- Study startMay 2011
- Primary completionJan 2013
- Study completionJan 2013
Why it stopped: No Participants enrolled; slow accrual
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stage III Prostate CancerStudies of the same condition, open and under way.
- More trials run by Wake Forest University Health SciencesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Majid Mirzazadeh, Principal investigator, Wake Forest University Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00996749
- Sponsor's protocol ID
- IRB00014553
- Other IDs
- NCI-2009-01340, CCCWFU 85108
- Status last verified
- Jul 2018
- First submitted
- 15 Oct 2009
- Last updated
- 3 Jul 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study to Determine the Optimal Dosage of Omega-3 Polyunsaturated Fatty Acid (PUFA) in Men With Advanced Prostate Cancer
- ClinicalTrials.gov ID
- NCT00996749
- Acronym / sponsor ID
- IRB00014553
- Conditions
- Stage III Prostate Cancer
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: No Participants enrolled; slow accrual
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- May 2011
- Primary completion
- Jan 2013 (actual)
- Study completion
- Jan 2013 (actual)
- First posted
- 16 Oct 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment (omega-3 fatty acid) | Experimental | Dietary Supplement: omega-3 fatty acid, Other: bone scan, Other: dual x-ray absorptometry, Other: laboratory biomarker analysis, Procedure: biopsyPatients receive long-term omega-3 PUFA supplementation PO. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| omega-3 fatty acidAlso: fish oil, n-3 fatty acid, O3FAGiven PO | Dietary supplement | Treatment (omega-3 fatty acid) |
| bone scanCorrelative studies | Other | Treatment (omega-3 fatty acid) |
| dual x-ray absorptometryAlso: DEXA scan, dual energy x-ray absorptometryCorrelative studies | Other | Treatment (omega-3 fatty acid) |
| laboratory biomarker analysisCorrelative studies | Other | Treatment (omega-3 fatty acid) |
| biopsyAlso: biopsiesCorrelative studies | Procedure or surgery | Treatment (omega-3 fatty acid) |
Primary outcome
Omega-3 fatty acid levels in serum and fat biopsies
Time frame: At 1 year
Omega-6 fatty acid levels in serum and fat biopsies
Time frame: At 1 year
Tolerability of omega-3 fatty acid supplementation
Time frame: At 1 month
Tolerability of omega-3 fatty acid supplementation
Time frame: At 6 months
Tolerability of omega-3 fatty acid supplementation
Time frame: At 12 months
5 secondary outcomes
Time to PSA progression
Time frame: At 1 year
Rates of PSA progression
Time frame: At 1 year
Status of bony metastasis
Time frame: At baseline
Bone density as assessed by dual energy x-ray absorptiometry (DEXA) scan
Time frame: At baseline
Bone density as assessed by DEXA scan
Time frame: At 1 year
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Majid Mirzazadeh principal investigator
Wake Forest University Health Sciences
Questions about this trial
What is this clinical trial studying?
A study testing omega-3 fatty acid, bone scan and dual x-ray absorptometry in people with Stage III Prostate Cancer, run by Wake Forest University Health Sciences.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 3 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Omega-3 fatty acid levels in serum and fat biopsies (time frame: At 1 year). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jul 2018.