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

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2014 by University of Washington
Sponsor:
Collaborator:
Information provided by (Responsible Party):
University of Washington
ClinicalTrials.gov Identifier:
NCT01731912
First received: November 19, 2012
Last updated: March 17, 2014
Last verified: March 2014

November 19, 2012
March 17, 2014
May 2013
December 2015   (final data collection date for primary outcome measure)
  • 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.
Same as current
Complete list of historical versions of study NCT01731912 on ClinicalTrials.gov Archive Site
Modulation of FSH receptor in tumor and tumoral/peritumoral endothelial cells, microvessel density by IHC for CD34, and PCR for angiopoietin and HIF-1 [ Time Frame: Up to 24 weeks ] [ Designated as safety issue: No ]
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Degarelix Acetate Before and During Radiation Therapy in Treating Patients With Prostate Cancer
Degarelix Acetate Prior to Radiation Therapy

This pilot clinical trial studies how well degarelix acetate before and during radiation therapy works in treating patients with prostate cancer. Androgens can cause the growth of prostate cancer cells. Drugs, such as degarelix acetate, may lessen the amount of androgens made by the body.

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). (Exploratory)

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

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.

Interventional
Not Provided
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Adenocarcinoma of the Prostate
  • Stage IIA Prostate Cancer
  • Stage IIB Prostate Cancer
  • Stage III Prostate Cancer
  • Stage IV Prostate Cancer
  • Drug: degarelix
    Given SC
    Other Names:
    • FE200486
    • Firmagon
  • Radiation: external beam radiation therapy
    Undergo standard EBRT
    Other Name: EBRT
  • Other: laboratory biomarker analysis
    Correlative studies
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.
Interventions:
  • Drug: degarelix
  • Radiation: external beam radiation therapy
  • Other: laboratory biomarker analysis
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
20
Not Provided
December 2015   (final data collection date for primary outcome measure)

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
Male
18 Years and older
No
United States
 
NCT01731912
7846, NCI-2012-02136, 7846, P30CA015704
No
University of Washington
University of Washington
National Cancer Institute (NCI)
Principal Investigator: Robert Montgomery Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
University of Washington
March 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP