Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:23 AM
Ignite Modification Date:
2025-12-25 @ 2:23 AM
NCT ID:
NCT03753334
Eligibility Criteria:
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.
Healthy Volunteers:
False
Sex:
MALE
Minimum Age:
18 Years
Maximum Age:
100 Years
Study:
NCT03753334
Study Brief:
Protocol Section:
NCT03753334