Degarelix Acetate Before and During Radiation Therapy in Treating Patients With Prostate Cancer
Stage IIA Prostate Cancer
Stage IIB Prostate Cancer
Stage III Prostate Cancer
Stage IV Prostate Cancer
Radiation: External Beam Radiation Therapy
Other: Laboratory Biomarker Analysis
|Study Design:||Endpoint Classification: Pharmacodynamics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Degarelix Acetate Prior to Radiation Therapy|
- Tissue levels of DHT in prostate and prostate cancer tissue as measured by mass spectometry [ Time Frame: At week 24 ] [ Designated as safety issue: No ]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.
- Tissue levels of testosterone in prostrate and prostate cancer tissue as measured by mass spectometry [ Time Frame: At week 24 ] [ Designated as safety issue: No ]Differences in tissue androgen levels between this group and historical comparisons will be evaluated by performing a one-way ANOVA, followed by pair-wise two-sample t-tests to determine which groups are statistically different.
- Modulation of FSH receptor in tumor and tumoral/peritumoral endothelial cells, microvessel density by immunohistochemistry for cluster of differentiation (CD)34, and PCR for angiopoietin and hypoxia-inducible factor (HIF)-1 [ Time Frame: Up to 24 weeks ] [ Designated as safety issue: No ]
|Study Start Date:||May 2013|
|Estimated Primary Completion Date:||November 2016 (Final data collection date for primary outcome measure)|
Experimental: Treatment (degarelix acetate, EBRT)
Patients receive degarelix acetate SC on day 1. Treatment repeats every 4 weeks for up to 6 courses. Beginning at week 15, patients also undergo standard EBRT for 8.5 weeks.
Other Names:Radiation: External Beam Radiation Therapy
Undergo standard EBRT
Other Names:Other: Laboratory Biomarker Analysis
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.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01731912
|United States, Washington|
|Fred Hutch/University of Washington Cancer Consortium||Recruiting|
|Seattle, Washington, United States, 98109|
|Contact: Robert B. Montgomery 206-598-0860 firstname.lastname@example.org|
|Principal Investigator: Robert B. Montgomery|
|Principal Investigator:||Robert Montgomery||Fred Hutch/University of Washington Cancer Consortium|