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

Completed · Not applicable

Conditions studied: Prostate Adenocarcinoma, Stage IIA Prostate Cancer, Stage IIB Prostate Cancer, Stage III Prostate Cancer, Stage IV Prostate Cancer

In brief

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.

Key facts

Study ID

NCT01731912

Run by

University of Washington

People needed

16

Starts

2013-05-01

Expected to finish

2016-09-01

Last updated by the study team

2019-01-18

Who can join

Age: 18 and older. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Fred Hutch/University of Washington Cancer Consortium — Seattle, Washington, United States

Full record on ClinicalTrials.gov

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