Degarelix Acetate Before and During Radiation Therapy in Treating Patients With Prostate Cancer
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|ClinicalTrials.gov Identifier: NCT01731912|
Recruitment Status : Completed
First Posted : November 22, 2012
Last Update Posted : September 28, 2017
|Condition or disease||Intervention/treatment||Phase|
|Prostate Adenocarcinoma Stage IIA Prostate Cancer Stage IIB Prostate Cancer Stage III Prostate Cancer Stage IV Prostate Cancer||Drug: Degarelix Radiation: External Beam Radiation Therapy Other: Laboratory Biomarker Analysis||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||21 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Degarelix Acetate Prior to Radiation Therapy|
|Study Start Date :||May 2013|
|Actual Primary Completion Date :||September 2016|
|Actual Study Completion Date :||September 2016|
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.
Radiation: External Beam Radiation Therapy
Undergo standard EBRT
Other: Laboratory Biomarker Analysis
- Tissue levels of DHT in prostate and prostate cancer tissue as measured by mass spectometry [ Time Frame: At week 24 ]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 ]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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01731912
|United States, Washington|
|Fred Hutch/University of Washington Cancer Consortium|
|Seattle, Washington, United States, 98109|
|Principal Investigator:||Robert Montgomery||Fred Hutch/University of Washington Cancer Consortium|