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 @ 12:37 AM
Ignite Modification Date:
2025-12-25 @ 12:37 AM
NCT ID:
NCT01143467
Eligibility Criteria:
* INCLUSION CRITERIA:
1. Clinically localized prostate cancer;
2. Scheduled to receive EBRT either by 3D conformal or IMRT techniques that is not anticipated to change during the course of the study, with or without Androgen Deprivation Therapy (ADT);
3. Able to provide written informed consent;
4. Men greater than or equal to 18 years of age;
5. Have enrolled in the study of molecular-genetic correlates of fatigue in cancer patients receiving localized radiation therapy (09-NR-0088).
EXCLUSION CRITERIA:
A. Any condition other than prostate cancer able to cause clinically significant fatigue including cardiovascular, pulmonary, gastrointestinal, central nervous system, psychiatric, endocrine, hematologic, renal, or immunologic disorders, and including patients with any of the following broad disease categories:
1. Systemic infections (e.g., human immunodeficiency virus \[HIV\], active hepatitis);
2. Documented history of major depression, bipolar disease, psychosis, or alcohol dependence/abuse within the past 5 years;
3. Uncorrected hypothyroidism and anemia;
4. Chronic inflammatory disease that may be anticipated to alter the proinflammatory cytokine profile (i.e. rheumatoid arthritis, systemic lupus erythematosus, cirrhosis).
B. Patients taking tranquilizers, steroids, and nonsteroidal anti-inflammatory agents because these medications are known to affect cytokine production;
C. Patients who have second malignancies or those receiving chemotherapy with their EBRT.
Healthy Volunteers:
False
Sex:
MALE
Minimum Age:
18 Years
Maximum Age:
100 Years
Study:
NCT01143467
Study Brief:
Protocol Section:
NCT01143467