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

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 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: September 15, 2014
Last verified: September 2014
  Purpose

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.


Condition Intervention
Adenocarcinoma of the Prostate
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

Study Type: Interventional
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

Resource links provided by NLM:


Further study details as provided by University of Washington:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 20
Study Start Date: May 2013
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
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

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01731912

Locations
United States, Washington
Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium Recruiting
Seattle, Washington, United States, 98109
Contact: Robert B. Montgomery    206-598-0860      
Principal Investigator: Robert B. Montgomery         
Sponsors and Collaborators
University of Washington
Investigators
Principal Investigator: Robert Montgomery Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
  More Information

No publications provided

Responsible Party: University of Washington
ClinicalTrials.gov Identifier: NCT01731912     History of Changes
Other Study ID Numbers: 7846, NCI-2012-02136, 7846, P30CA015704
Study First Received: November 19, 2012
Last Updated: September 15, 2014
Health Authority: United States: Federal Government

Additional relevant MeSH terms:
Prostatic Neoplasms
Adenocarcinoma
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type

ClinicalTrials.gov processed this record on September 22, 2014