Clinical trial · Interventional
Polyunsaturated Fatty Acids in Treating Patients With Prostate Cancer Undergoing Prostate Biopsy and/or Surgery
Prostate Cancer Prevention by n-3 Unsaturated Fatty Acids
NCT00458549CI-TRIAL-00033755terminatedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Slow Accrual
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| biopsy | Procedure | — | UNRESOLVED |
| omega-3 fatty acids | Dietary Supplement | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- omega-3 fatty acids
- description
- omega-3 fatty acids Oral 8g once a day for 21 days prior to (biopsy) surgery
- interventionNames
- Dietary Supplement: omega-3 fatty acids
- Procedure: biopsy
- type
- PLACEBO_COMPARATOR
- label
- Corn Oil
- description
- Oral 8g once a day for 21 days prior to (biopsy) surgery
- interventionNames
- Procedure: biopsy
Primary outcomes (2)
- measure
- Level of eIF2α phosphorylation and Gleason score in prostate biopsy samples (Part 1)
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
- Maximum age
- 120 Years
Show eligibility criteria text
Inclusion Criteria: * 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) Exclusion Criteria: * 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 * 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.
References
Publications (0)
Data not yet available
No reference posted for this study.