Status:
ACTIVE_NOT_RECRUITING
Effects of EPA in Men With Biochemical Recurrence or Progression of Prostate Cancer.
Lead Sponsor:
CHU de Quebec-Universite Laval
Conditions:
Prostate Cancer
Eligibility:
MALE
18-100 years
Phase:
PHASE2
Brief Summary
Prostate cancer biochemical recurrence (BCR) occurs in 20-50% of patients following radical prostatectomy or radiotherapy. Due to significant risk of side effects and uncertainty about the benefits, p...
Eligibility Criteria
Inclusion
- Patients must have a histologically or cytologically confirmed history of adenocarcinoma of the prostate.
- Patients must have a PSA failure defined as PSA of \>= 0.5 ng/ml that has increased above nadir following radical prostatectomy (RP); or a PSA increase of 2.0 above post-therapy nadir after radiotherapy (RT); or a PSA increase between 0.05-0.49 ng/ml that has increased above nadir following RP. The maximal PSA value at enrolment must be \<5.0 ng/mL after RP and \<6 ng/mL after RT.
- PSA value must be increasing based on three consecutive measurements each separated by at least 4 weeks prior to enrolment to this study.
- Patients may have received any number of local therapies (RP, external beam RT or brachytherapy).
- Provide written informed consent.
Exclusion
- Patients with evidence of metastatic disease.
- Patients who have received prior cytotoxic chemotherapy for recurrent disease.
- Patients currently receiving biological response modifiers, or corticosteroids.
- Uncontrolled intercurrent illness including, but not limited to, ongoing active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness or social situations that would limit compliance with study requirements.
- Use of omega-3 or any other dietary supplements for the previous 3 months and during study is not allowed.
- Known allergy to fish or shellfish or sunflower.
Key Trial Info
Start Date :
July 10 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2026
Estimated Enrollment :
39 Patients enrolled
Trial Details
Trial ID
NCT03753334
Start Date
July 10 2017
End Date
December 1 2026
Last Update
December 19 2025
Active Locations (1)
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1
Centre de Recherche Clinique et Évaluative en Oncologie - Hôtel-Dieu de Québec
Québec, Quebec, Canada, G1R 3S1