Degarelix Acetate Before and During Radiation Therapy in Treating Patients With Prostate Cancer

PRIMARY OBJECTIVES:

I. To evaluate the effect of neoadjuvant degarelix (degarelix acetate) on prostate
dihydrotestosterone (DHT) and testosterone levels.

SECONDARY OBJECTIVES:

I. To determine the effect of degarelix acetate on androgen-regulated gene expression and
apoptosis as assessed by immunohistochemistry, complementary deoxyribonucleic acid (cDNA)
microarray analysis and reverse transcriptase (RT)-polymerase chain reaction (PCR).

II. To determine the effect of degarelix acetate on follicle stimulating hormone (FSH) and
FSH receptor expression in prostate cancer and surrounding microenvironment.

OUTLINE:

Patients receive degarelix acetate subcutaneously (SC) on day 1. Treatment repeats every 4
weeks for up to 6 courses. Beginning at week 15, patients also undergo standard external beam
radiation therapy (EBRT) for 8.5 weeks.

Inclusion Criteria:

- Willing and able to provide written informed consent

- Written authorization for use and release of health and research study information has
been obtained

- Histologically proven adenocarcinoma of the prostate

- Patients must be candidates for short or long term androgen deprivation in combination
with external beam radiation therapy (RT) based on the following criteria:

- Intermediate risk disease: T2b/c, or Gleason 7, or prostate-specific antigen
(PSA) 10-20

- High risk disease: Gleason 8-10, or PSA > 20, or T3/4

- Patients may not have received any prior pharmacologic therapy or RT for prostate
cancer

- Eastern Cooperative Oncology Group (ECOG) performance status =< 2 (Karnofsky >= 60%)

- Eligibility of patients receiving any medications or substances known to affect or
with the potential to affect the androgen axis will be determined following review of
their case by the principal investigator

- Patients must allow biopsy at the time of fiducial placement

Exclusion Criteria:

- Patients may not be receiving any investigational agents

- Patients who are currently receiving active therapy for other neoplastic disorders
will not be eligible

- Patients with histologic evidence of small cell carcinoma of the prostate will not be
eligible

- Patients with hypogonadism or severe androgen deficiency as defined by serum
testosterone less than 100 ng/dL will not be eligible

- History of pituitary dysfunction

- Patients who are receiving any androgens, estrogens or progestational agents, or who
received any of these agents within the 6 months prior to evaluation will not be
eligible

- Patients who are taking drugs which affect androgen metabolism (e.g. spironolactone,
ketoconazole, finasteride, dutasteride) will not be eligible; patients who received
any of these agents within the 6 months prior to evaluation will be reviewed for
eligibility by the principal investigator on a case by case basis

- Patients with inflammatory bowel disease or other autoimmune conditions which might
affect the radiated colon or rectum

- Patients with uncontrolled intercurrent illness including, but not limited to, ongoing
or active infection, unstable angina pectoris, cardiac arrhythmia which is symptomatic
or requires active therapy, recent deep venous thrombosis, pulmonary emboli,
cerebrovascular accident or ischemia will not be eligible

- Patients with dementia/psychiatric illness/social situations that would limit
compliance with study requirements or would prohibit the understanding and/or giving
of informed consent will not be eligible

- Patients with medical conditions, which, in the opinion of the investigators, would
jeopardize either the patient or the integrity of the data obtained will not be
eligible

- Other active malignancy, except non-melanoma skin cancer and superficial bladder
cancer

- Patients unwilling to use contraceptives while on study