Fish oil may delay hormone therapy in prostate cancer patients
NCT ID NCT03753334
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests whether a daily high-dose omega-3 supplement (fish oil) can slow the rise of PSA levels in men whose prostate cancer has returned after initial treatment. About 40 men with a rising PSA but no spread will take either the supplement or a placebo for one year. The goal is to see if omega-3s can delay the need for hormone therapy, which often has harsh side effects.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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39 people
The number who actually took part.
- Started
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Jul 2017
- Expected to finish
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Dec 2026
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 100 years
- Sex
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Male participants only
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * 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 Criteria: * 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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Centre de Recherche Clinique et Évaluative en Oncologie - Hôtel-Dieu de Québec
Québec, Quebec, G1R 3S1, Canada
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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