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A Study of Degarelix in Patients With Prostate Cancer

Information source: Ferring Pharmaceuticals
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Prostate Cancer

Intervention: Degarelix (Drug); Degarelix (Drug); Lupron (Leuprolide) (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Ferring Pharmaceuticals

Official(s) and/or principal investigator(s):
Clinical Development Support, Study Director, Affiliation: Ferring Pharmaceuticals

Summary

The purpose is to see if giving Degarelix every month for 7 months then stop treatment for 7 months (intermittent therapy) will show a reduction of negative effects of androgen deprivation therapy by increasing the quality of life while keeping prostate specific antigen (PSA) levels suppressed.

Clinical Details

Official title: A Randomized, Controlled, Open-Label Study Investigating the Safety and Efficacy of Degarelix Given Intermittently vs Continuous Androgen Deprivation Therapy With Lupron or Degarelix in Patients With Prostate Cancer With Prior Treatment Failure After Localized Treatment

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: PSA

Secondary outcome:

1. Reported Outcome Quality of Life intermittent treatment & continuous treatment

2. PSA

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Male.

Criteria:

Inclusion Criteria:

- 18 years or older.

- Raising PSA after prior treatment failure of localized prostate cancer.

- Has a histological confirmed non-metastatic cancer of the prostate (Gleason graded)

based on the most current biopsy.

- Has a screening testosterone with-in normal range ≥1. 5 ng/mL.

- Has ECOG score of ≤2.

- CT scan, MRI or bone scan report documenting no evidence of metastasis to the bone or

internal organs.

- Life expectancy of at least 15 months.

Exclusion Criteria:

- Taken hormone therapy in the last 6 months prior to entering this study.

- Has a history of sever uncontrolled asthma, anaphylactic reactions, or sever

urticaria and/or angioedema.

- Has hypersensitivity towards any component of the study drug.

- Has a previous history or presence of another malignancy other than prostate cancer

or treated squamous/basel cell carcinoma of the skin within the last five years.

- Abnormal laboratory results which in the judgement of the Investigator would affect

the patient's health or the outcome of the trial.

- Has a clinically significant medical condition (other than prostate cancer) including

but not limited to; renal, haematological, gastrointestinal, endocrine, cardiac, neurological or psychiatric disease and alcohol or drug abuse or any other condition which may affect the patient's health or the outcome of the trial as judged by the Investigator.

- Has an intellectual incapacity or language barriers precluding adequate understanding

or co-operation.

- Has received an investigational drug within the last 28 days before the Screening

visit or longer if considered to possibly influence the outcome of the current trial.

- Has previously participated in any Degarelix trial.

- Is part of an ongoing trial.

Locations and Contacts

Alabama Clinical Research, Inc, Alexander City, Alabama, United States

Urology Center of Alabama, PC, Homewood, Alabama, United States

Advanced Urology Medical Center, Anaheim, California, United States

Peninsula Urology Medical Center, Atherton, California, United States

Urology Associates of Central California, Fresno, California, United States

South Orange County Medical Research Center, Laguna Hills, California, United States

Atlantic Urology Medical Group, Long Beach, California, United States

San Bernardino Urological Associates, San Bernardino, California, United States

San Diego Uro-Research, San Diego, California, United States

Santa Barbara Clinical Research, Santa Barbara, California, United States

University of Colorado Health Sciences Center, Aurora, Colorado, United States

The Urology Center of Colorado, Denver, Colorado, United States

Urology Associates Research, Englewood, Colorado, United States

Connecticut Clinical Research Center, Middlebury, Connecticut, United States

Grove Hill Medical Center, New Britain, Connecticut, United States

Walter Reed Army Hospital Medical Center, Washington, District of Columbia, United States

South Florida Medical Research, Aventura, Florida, United States

Urology Health Solutions, Inc, Celebration, Florida, United States

Florida Urology Physicians, Fort Myers, Florida, United States

University of Florida, Gainesville, Florida, United States

Winter Park Urology Associates, Orlando, Florida, United States

Southeastern Urology Center, PA, Tallahassee, Florida, United States

Tampa Bay Urology, Tampa, Florida, United States

Advanced Research Institute, Inc, Trinity, Florida, United States

Urology Enterprises, Marietta, Georgia, United States

Midwest Urology/RMD Clinical Research Institute, Melrose Park, Illinois, United States

Deaconess Clinic Inc, Evansville, Indiana, United States

Northeast Indiana Research, Fort Wayne, Indiana, United States

Metropolitan Urology, PSC, Jeffersonville, Indiana, United States

Regional Urology, Lic, Shreveport, Louisiana, United States

Chesapeake Urology Associates, Baltimore, Maryland, United States

Chesapeake Urology Research Associates, Baltimore, Maryland, United States

Chesapeake Urology Research Associates, Glen Burnie, Maryland, United States

Myron Murdock M.D. LLC, Greenbelt, Maryland, United States

Chesapeake Urology Associates, PA, Towson, Maryland, United States

Urology Associates of Englewood, Englewood, New Jersey, United States

Hamilton Urology PA, Hamilton, New Jersey, United States

Lawrenceville Urology, Lawrenceville, New Jersey, United States

Nationsmed Clinical Research, Perth Amboy, New Jersey, United States

Center for Urologic Care, Voorhees, New Jersey, United States

Delaware Valley Urology LLC, Westampton, New Jersey, United States

The Urological Institute of NE NY, CCP, Albany, New York, United States

Medical & Clinical Research Associates, Bay Shore, New York, United States

Brooklyn Heights Urology Associates, P.C., Brooklyn, New York, United States

University Urology Associates, New York, New York, United States

Hudson Valley Urology P.C., Poughkeepsie, New York, United States

Northeast Urology Research, Concord, North Carolina, United States

Alliance Urology Specialists, Greensboro, North Carolina, United States

Urological Association of Lancaster, Lancaster, Pennsylvania, United States

State College Urologic Association, State College, Pennsylvania, United States

Carolina Urologic Research Center, Myrtle Beach, South Carolina, United States

Lexington Urological Associates, PA, West Columbia, South Carolina, United States

Urology Associates, Nashville, Tennessee, United States

Lackland Air Force base, San Antonio, Texas, United States

Urology of Virginia, Norfolk, Virginia, United States

Virginal Urology, Richmond, Virginia, United States

Virginia Urology Center, Richmond, Virginia, United States

Seattle Urology Research Center, Seattle, Washington, United States

Roger D. Fincher, PS, Spokane, Washington, United States

Additional Information

Starting date: May 2009
Last updated: September 27, 2013

Page last updated: August 23, 2015

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