Prostate CancerNCT00458549
Polyunsaturated Fatty Acids in Treating Patients With Prostate Cancer Undergoing Prostate Biopsy and/or Surgery
A study testing omega-3 fatty acids and biopsy in people with Prostate Cancer, run by Dana-Farber Cancer Institute at 2 sites in United States.
Trial summary
RATIONALE: Polyunsaturated fatty acids are important for normal growth and development. One type, called omega-3 fatty acids (found in fish, fish oil, and some other foods), may affect the growth of prostate cancer. Read more about this study
- Who is it for?
- Ages 18 to 120 years, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- omega-3 fatty acids and biopsy
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 232 participants
- Where
- 2 sitesUnited States
- Study dates
- 27 May 2003to 1 May 2012
- 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 to 120 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men undergoing an outpatient prostate biopsy independently indicated by a physician.
- Patients will be selected from the population initially studied with a prostate biopsy for possible prostate cancer
- sub-group without evidence of cancer
- sub-group with advanced prostate cancer beyond the currently accepted criteria for surgical treatment,
- sub-group with indication of radical prostatectomy
- Patients will be recruited from the population of patients from Brigham and Women's Hospital for surgery referred from other institutions/doctors where their biopsy was taken and the diagnosis of prostate cancer was originally made. These patients are not eligible for Aim 1 but will enter the randomized trial (Aim 2 with baseline)
Who cannot join
- Prostate biopsy patients who do not accept and sign an informed consent form to
- donate ten ml of blood for fatty acid analysis in red blood cells
- allow their prostate biopsy to be analyzed as discarded pathological material
- authorize access to their hospital clinical information for follow up studies
- Patients with a current diagnosis of a condition that might interfere with the measurements of fatty acids in red blood cell membranes such as severe anemia (less than 9g/100m1% hemoglobin
- -- Or
Show all 9Show fewer
- Diseases of lipid metabolism such as familial dyslipoproteinemia, liver cirrhosis, advanced renal failure, and malabsorption syndrome.
- Exclude from this study patients from (indication of radical prostatectomy) who refuse the surgical recommendation or schedule surgery at a location other than Brigham and Women's Hospital.
- Patients who are not able to complete the full program will not be taken into consideration in the final data analysis.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Brigham and Women's Hospital
Boston, Massachusetts, 02115
Dana Farber Cancer Institute
Boston, Massachusetts, 02115
About this study
Official title: Prostate Cancer Prevention by n-3 Unsaturated Fatty Acids
RATIONALE: Polyunsaturated fatty acids are important for normal growth and development. One type, called omega-3 fatty acids (found in fish, fish oil, and some other foods), may affect the growth of prostate cancer.
PURPOSE: This randomized clinical trial is studying polyunsaturated fatty acids in treating patients with prostate cancer undergoing prostate biopsy and/or surgery.
Read the detailed description
OBJECTIVES:
- Compare fatty acid analysis of red blood cells, levels of eIF2α phosphorylation, and tumor differentiation grade, as measured by Gleason score, in patients undergoing prostate biopsy. (Part 1)
- Determine if neoadjuvant n-3 polyunsaturated fatty acids (PUFAs) induce phosphorylation of eIF2α in these patients. (Part 2)
- Compare eIF2α phosphorylation, Gleason score, and the time to prostate-specific antigen failure in prostate tumor samples obtained from the Gelb Center of the Dana-Farber Cancer Institute prostate tissue repository. (Part 3)
OUTLINE: This is a prospective study, followed by a randomized, double-blind, placebo-controlled study, followed by a retrospective study.
- Part 1: Patients undergo tumor biopsy and blood sample collection at baseline. Samples are analyzed by gas-liquid chromatography for determination of n-3 and n-6 polyunsaturated fatty acid (PUFA) red cell membrane concentrations. Biopsy samples are analyzed for eIF2α phosphorylation by immunohistochemistry. Some patients proceed to part 2.
- Part 2: Patients undergo blood sampling as in part 1 with additional tumor and blood collection on day 28. Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients receive oral n-3 PUFAs (fish oil) once daily for 28 days prior to tumor resection.
- Arm II (control): Patients receive oral n-6 PUFAs (corn oil) once daily for 28 days prior to tumor resection.
- Part 3: Tumor samples and associated pathology data (Gleason score) and clinical data (PSA values and patient's outcome) are obtained from a prostate tissue repository at the Gelb Center of the Dana-Farber Cancer Institute. Samples are analyzed to correlate eIF2α phosphorylation, Gleason scores, and time to PSA failure.
PROJECTED ACCRUAL: A total of 600 patients and 1,000 stored tissue samples will be accrued for this study.
- Conditions
- Prostate Cancer
- Being tested
- omega-3 fatty acids, biopsy
- Keywords
- stage I prostate cancer, stage II prostate cancer, stage III prostate cancer, stage IV prostate cancer
- 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 acidsDietary supplement
Also called OmegaRx
omega-3 fatty acids Oral 8g once a day for 21 days prior to (biopsy) surgery
biopsyProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| omega-3 fatty acids | Experimental | omega-3 fatty acids Oral 8g once a day for 21 days prior to (biopsy) surgery Receives: Dietary Supplement: omega-3 fatty acids; Procedure: biopsy |
| Corn Oil | Placebo comparator | Oral 8g once a day for 21 days prior to (biopsy) surgery Receives: Procedure: biopsy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Level of eIF2α phosphorylation and Gleason score in prostate biopsy samples (Part 1)
Measured: 21 Days
Change in phosphorylation level of eIF2α before and after n-3 polyunsaturated fatty acid supplementation (Part 2)
Measured: 21 Days
Secondary outcomes (1)
Relapse-free survival (Part 2)
detectable (> 0.1ng/m1) values following an undetectable level
Measured: Time between surgery and the time of PSA failure 6 months and 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2007 (estimated)
- Study start27 May 2003
- Primary completion14 May 2009
- Study completion1 May 2012
Why it stopped: Slow Accrual
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- More trials run by Dana-Farber Cancer InstituteThe 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 232 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dana-Farber Cancer Institute
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Principal investigator, Jose A. Halperin, Dana-Farber Cancer Institute
- Investigators
- Jose A. Halperin, MD, Principal investigator, Dana-Farber Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00458549
- Sponsor's protocol ID
- 03-116
- Other IDs
- R01CA101034, P30CA006516
- Status last verified
- Jul 2018
- First submitted
- 9 Apr 2007
- Last updated
- 13 Jul 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prostate Cancer Prevention by n-3 Unsaturated Fatty Acids
- ClinicalTrials.gov ID
- NCT00458549
- Acronym / sponsor ID
- 03-116
- Conditions
- Prostate Cancer
- Keywords
- stage I prostate cancer, stage II prostate cancer, stage III prostate cancer, stage IV prostate cancer
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Slow Accrual
- Enrolment
- 232 participants (actual)
- Lead sponsor
- Dana-Farber Cancer InstituteUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 27 May 2003 (actual)
- Primary completion
- 14 May 2009 (actual)
- Study completion
- 1 May 2012 (actual)
- First posted
- 11 Apr 2007 (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.
RATIONALE: Polyunsaturated fatty acids are important for normal growth and development. One type, called omega-3 fatty acids (found in fish, fish oil, and some other foods), may affect the growth of prostate cancer.
PURPOSE: This randomized clinical trial is studying polyunsaturated fatty acids in treating patients with prostate cancer undergoing prostate biopsy and/or surgery.
Detailed description
OBJECTIVES:
- Compare fatty acid analysis of red blood cells, levels of eIF2α phosphorylation, and tumor differentiation grade, as measured by Gleason score, in patients undergoing prostate biopsy. (Part 1)
- Determine if neoadjuvant n-3 polyunsaturated fatty acids (PUFAs) induce phosphorylation of eIF2α in these patients. (Part 2)
- Compare eIF2α phosphorylation, Gleason score, and the time to prostate-specific antigen failure in prostate tumor samples obtained from the Gelb Center of the Dana-Farber Cancer Institute prostate tissue repository. (Part 3)
OUTLINE: This is a prospective study, followed by a randomized, double-blind, placebo-controlled study, followed by a retrospective study.
- Part 1: Patients undergo tumor biopsy and blood sample collection at baseline. Samples are analyzed by gas-liquid chromatography for determination of n-3 and n-6 polyunsaturated fatty acid (PUFA) red cell membrane concentrations. Biopsy samples are analyzed for eIF2α phosphorylation by immunohistochemistry. Some patients proceed to part 2.
- Part 2: Patients undergo blood sampling as in part 1 with additional tumor and blood collection on day 28. Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients receive oral n-3 PUFAs (fish oil) once daily for 28 days prior to tumor resection.
- Arm II (control): Patients receive oral n-6 PUFAs (corn oil) once daily for 28 days prior to tumor resection.
- Part 3: Tumor samples and associated pathology data (Gleason score) and clinical data (PSA values and patient's outcome) are obtained from a prostate tissue repository at the Gelb Center of the Dana-Farber Cancer Institute. Samples are analyzed to correlate eIF2α phosphorylation, Gleason scores, and time to PSA failure.
PROJECTED ACCRUAL: A total of 600 patients and 1,000 stored tissue samples will be accrued for this study.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| omega-3 fatty acids | Experimental | Dietary Supplement: omega-3 fatty acids, Procedure: biopsyomega-3 fatty acids Oral 8g once a day for 21 days prior to (biopsy) surgery |
| Corn Oil | Placebo comparator | Procedure: biopsyOral 8g once a day for 21 days prior to (biopsy) surgery |
Who may qualify
- Ages
- 18 to 120 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Men undergoing an outpatient prostate biopsy independently indicated by a physician.
- Patients will be selected from the population initially studied with a prostate biopsy for possible prostate cancer
- Patients will be recruited from the population of patients from Brigham and Women's Hospital for surgery referred from other institutions/doctors where their biopsy was taken and the diagnosis of prostate cancer was originally made. These patients are not eligible for Aim 1 but will enter the randomized trial (Aim 2 with baseline)
Key exclusion criteria (9 listed)
- Prostate biopsy patients who do not accept and sign an informed consent form to
- Patients with a current diagnosis of a condition that might interfere with the measurements of fatty acids in red blood cell membranes such as severe anemia (less than 9g/100m1% hemoglobin
- -- Or
- Diseases of lipid metabolism such as familial dyslipoproteinemia, liver cirrhosis, advanced renal failure, and malabsorption syndrome.
- Exclude from this study patients from (indication of radical prostatectomy) who refuse the surgical recommendation or schedule surgery at a location other than Brigham and Women's Hospital.
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 acidsAlso: OmegaRxomega-3 fatty acids Oral 8g once a day for 21 days prior to (biopsy) surgery | Dietary supplement | omega-3 fatty acids |
| biopsy | Procedure or surgery | Corn Oil, omega-3 fatty acids |
Primary outcome
Level of eIF2α phosphorylation and Gleason score in prostate biopsy samples (Part 1)
Time frame: 21 Days
Change in phosphorylation level of eIF2α before and after n-3 polyunsaturated fatty acid supplementation (Part 2)
Time frame: 21 Days
1 secondary outcome
Relapse-free survival (Part 2)
Time frame: Time between surgery and the time of PSA failure 6 months and 9 months
Results and safety
The study was stopped early (reason given: Slow Accrual). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jul 2018.
- Individual participant dataSharing planned: No
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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.
Jose A. Halperin, MD principal investigator
Dana-Farber Cancer Institute
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing omega-3 fatty acids and biopsy in people with Prostate Cancer, run by Dana-Farber Cancer Institute at 2 sites in United States.
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 6 inclusion and 9 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: stopped early, as of the sponsor's last update on 13 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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 stopped early (reason given: Slow Accrual). Results are not available in the source record.
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?
Level of eIF2α phosphorylation and Gleason score in prostate biopsy samples (Part 1) (time frame: 21 Days). The study lists 2 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 13 Jul 2018.