Degarelix Acetate Prior to Radiation Therapy
I. To evaluate the effect of neoadjuvant degarelix (degarelix acetate) on prostate
dihydrotestosterone (DHT) and testosterone levels.
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. (Exploratory)
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.
Endpoint Classification: Pharmacodynamics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Tissue levels of DHT in prostate and prostate cancer tissue as measured by mass spectometry
Differences in tissue androgen levels between this group and historical comparisons will be evaluated by performing a one-way analysis of variance (ANOVA), followed by pair-wise two-sample t-tests to determine which groups are statistically different.
At week 24
Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
United States: Federal Government
|Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium||Seattle, Washington 98109|