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:
2025-12-24 @ 9:18 PM
Ignite Modification Date:
2025-12-24 @ 9:18 PM
NCT ID:
NCT01434004
Eligibility Criteria:
Inclusion Criteria:
* have a histologically confirmed diagnosis of adenocarcinoma of the prostate
* have been treated by radical prostatectomy or radiation therapy
* have had no malignancy in the past 5 years (except the primary prostate cancer for which initial treatment was sought and non malignant melanoma of the skin)
* not be taking thyroid medication, antibiotics, diuretics or steroids
* be able to read at a sixth grade level
* speak English as their first language
* be of sound mind, memory, and understanding as evaluated by recruitment staff
* have experienced a rise in serum PSA concentration after achieving a post surgery nadir, after achieving a post radiation nadir, or having had both a radical prostatectomy and subsequent radiotherapy
Exclusion Criteria:
* has received high dose radiotherapy or brachytherapy in place of surgery as a primary treatment
* has received post-operative hormone therapy for prostate cancer
* received treatment of prostate cancer with an LH-RH analog
* has a diagnosis of cardiovascular, pulmonary, or metabolic disease or major symptoms of these diseases, including pain or discomfort in the chest, neck, jaw, arms or other areas that may be due to ischemia; shortness of breath or unusual fatigue at rest or with mild exertion; dizziness; dyspnea while sleeping; ankle edema or intermittent claudication; palpitations, tachycardia, or a known heart murmur
* has experienced a weight loss in excess of five pounds in the previous 3 months
* regularly consumes more than two alcoholic drinks per day
* plans on taking hormone supplements such as melatonin, or fish oil or other; supplements rich in omega-3 fatty acids
* has been diagnosed with Crohn's disease or has active ulcerative colitis
* has been diagnosed with Post Traumatic Stress Disorder (PTSD)
Healthy Volunteers:
False
Sex:
MALE
Minimum Age:
18 Years
Study:
NCT01434004
Study Brief:
Protocol Section:
NCT01434004