Molecular-Genetic Correlates of Fatigue in Cancer Patients Receiving Localized External Beam Radiation Therapy

Inclusion Criteria

- INCLUSION CRITERIA:

To be included, patients must meet all of the following criteria:

- Clinically localized prostate cancer with or without prior prostatectomy;

- 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 ADT;

- No known medical history of tuberculosis (TB);

- Able to provide written informed consent;

- Men greater than or equal to18 years of age;

The control group must meet all the inclusion criteria mentioned above except for number
2. The control group must not be receiving any form of treatment for their prostate
cancer to include hormone, immune, radiation, or chemotherapy.

EXCLUSION CRITERIA:

All participants with any one of the following criteria will be excluded:

Progressive or unstable disease of any body system causing 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:

- Systemic infections (e.g., human immunodeficiency virus [HIV], active hepatitis);

- Documented history of major depression, bipolar disease, psychosis, or alcohol
dependence/abuse within the past 5 years;

- Uncorrected hypothyroidism and anemia;

- Chronic inflammatory disease that may be anticipated to alter the proinflammatory
cytokine profile (i.e. rheumatoid arthritis, systemic lupus erythematosus, and
cirrhosis).

Patients taking tranquilizers, steroids, and nonsteroidal anti-inflammatory agents because
these medications are known to affect cytokine production;

Patients who have second malignancies or those receiving chemotherapy with their EBRT.

In addition to the above criteria, participants with the following conditions will be
excluded from participating in the exercise interventions:

1. Significant Restrictive or Obstructive Lung Disease

2. Ischemic heart disease

3. Left ventricular dysfunction with the ejection fraction less than 40 or a documented
pulmonary capillary wedge pressure greater than or equal to 18mmHg.

4. Acute corpulmonale

5. Cardiomyopathy (dilated, hypertrophic, or non-idiopathic)

6. Significant renal or hepatic dysfunction

7. Disabling stroke

8. Uncontrolled diabetes mellitus with a history of diabetic ketoacidosis

9. Mitochondrial disease

Subjects will also be excluded from participating in the MRS pilot study if they have the
following conditions:

1. Patients with implanted cardiac pacemakers, metal aneurysm clips, or who have had
broken bones repaired with metal pins, screws, rods, plates, or those with prosthetic
eye implants, with transdermal medications or infusion pumps.

2. Patients with bullet fragments or other metal pieces in their body from old wounds.

3. Patients with significant work exposure to metal particles.

4. Patients with psychological contraindications for MRI (e.g. claustrophobia).