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

NCT ID: NCT01731912

Last Updated: 2019-01-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 16 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-05-31
• Study Completion Date: 2016-09-30

Brief Summary

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. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. Giving degarelix acetate together with radiation therapy may work better in treating prostate cancer.

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).

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

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.

Conditions

Prostate Adenocarcinoma; Stage IIA Prostate Cancer; Stage IIB Prostate Cancer; Stage III Prostate Cancer; Stage IV Prostate Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Degarelix

Intervention Type: DRUG

Given SC

External Beam Radiation Therapy

Intervention Type: RADIATION

Undergo standard EBRT

Laboratory Biomarker Analysis

Intervention Type: OTHER

Correlative studies

Interventions

Degarelix

Given SC

Intervention Type: DRUG

External Beam Radiation Therapy

Undergo standard EBRT

Intervention Type: RADIATION

Laboratory Biomarker Analysis

Correlative studies

Intervention Type: OTHER

Other Intervention Names

FE200486; Firmagon; Definitive Radiation Therapy; EBRT; External Beam Radiotherapy; External Beam RT; external radiation; External Radiation Therapy; external-beam radiation

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

University of Washington

OTHER

Sponsor Role: lead

Responsible Party

Bruce Montgomery

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Robert Montgomery

Role: PRINCIPAL_INVESTIGATOR

Fred Hutch/University of Washington Cancer Consortium

Locations

Fred Hutch/University of Washington Cancer Consortium

Seattle, Washington, United States

Countries

United States

Other Identifiers

NCI-2012-02136

Identifier Type: REGISTRY

Identifier Source: secondary_id

RAD2

Identifier Type: -

Identifier Source: secondary_id

7846

Identifier Type: OTHER

Identifier Source: secondary_id

P30CA015704

Identifier Type: NIH

Identifier Source: secondary_id

View Link

7846

Identifier Type: -

Identifier Source: org_study_id