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

NCT01731912 | Completed Results

• 4 other identifiers: 7846NCI-2012-02136RAD2P30CA015704
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (2)

• Tissue Levels of DHT in Prostate Tissue as Measured by Mass Spectometry

  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.

  At week 24

• Tissue Levels of Testosterone in Prostate Tissue as Measured by Mass Spectometry

  At week 24

Study Arms (1)

Treatment (degarelix acetate, EBRT)

EXPERIMENTAL

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; Radiation: External Beam Radiation Therapy; Other: Laboratory Biomarker Analysis

Interventions

Degarelix DRUG

Given SC

Also known as: FE200486, Firmagon

Treatment (degarelix acetate, EBRT)

External Beam Radiation Therapy RADIATION

Undergo standard EBRT

Also known as: Definitive Radiation Therapy, EBRT, External Beam Radiotherapy, External Beam RT, external radiation, External Radiation Therapy, external-beam radiation

Treatment (degarelix acetate, EBRT)

Laboratory Biomarker Analysis OTHER

Correlative studies

Treatment (degarelix acetate, EBRT)

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• University of Washington: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Fred Hutch/University of Washington Cancer Consortium

Seattle, Washington, 98109, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

acetyl-2-naphthylalanyl-3-chlorophenylalanyl-1-oxohexadecyl-seryl-4-aminophenylalanyl(hydroorotyl)-4-aminophenylalanyl(carbamoyl)-leucyl-ILys-prolyl-alaninamide

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Results Point of Contact

• Title: Dr. Bruce Montgomery
• Organization: University of Washington

rbmontgo@uw.edu

206-598-0860

Study Officials

• Robert Montgomery

  Fred Hutch/University of Washington Cancer Consortium

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 19, 2012
• First Posted: November 22, 2012
• Study Start: May 1, 2013
• Primary Completion: September 1, 2016
• Study Completion: September 1, 2016
• Last Updated: January 18, 2019
• Results First Posted: January 18, 2019

Record last verified: 2018-12

Locations

US (1)