A Study of Degarelix in Patients With Prostate Cancer

Prostate Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00928434
• Other study ID #: FE200486 CS37
• Secondary ID: RISPSA
• Status: Completed
• Phase: Phase 3
• First received: June 25, 2009
• Last updated: September 27, 2013
• Start date: May 2009
• Est. completion date: September 2012

Study information

• Verified date: September 2013
• Source: Ferring Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 405
• Est. completion date: September 2012
• Est. primary completion date: September 2012
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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.

Study Design

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

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Drug:
• Degarelix

• Degarelix

• Lupron (Leuprolide)

Locations

Country	Name	City	State
United States	The Urological Institute of NE NY, CCP	Albany	New York
United States	Alabama Clinical Research, Inc	Alexander City	Alabama
United States	Advanced Urology Medical Center	Anaheim	California
United States	Peninsula Urology Medical Center	Atherton	California
United States	University of Colorado Health Sciences Center	Aurora	Colorado
United States	South Florida Medical Research	Aventura	Florida
United States	Chesapeake Urology Associates	Baltimore	Maryland
United States	Chesapeake Urology Research Associates	Baltimore	Maryland
United States	Medical & Clinical Research Associates	Bay Shore	New York
United States	Brooklyn Heights Urology Associates, P.C.	Brooklyn	New York
United States	Urology Health Solutions, Inc	Celebration	Florida
United States	Northeast Urology Research	Concord	North Carolina
United States	The Urology Center of Colorado	Denver	Colorado
United States	Urology Associates of Englewood	Englewood	New Jersey
United States	Urology Associates Research	Englewood	Colorado
United States	Deaconess Clinic Inc	Evansville	Indiana
United States	Florida Urology Physicians	Fort Myers	Florida
United States	Northeast Indiana Research	Fort Wayne	Indiana
United States	Urology Associates of Central California	Fresno	California
United States	University of Florida	Gainesville	Florida
United States	Chesapeake Urology Research Associates	Glen Burnie	Maryland
United States	Myron Murdock M.D. LLC	Greenbelt	Maryland
United States	Alliance Urology Specialists	Greensboro	North Carolina
United States	Hamilton Urology PA	Hamilton	New Jersey
United States	Urology Center of Alabama, PC	Homewood	Alabama
United States	Metropolitan Urology, PSC	Jeffersonville	Indiana
United States	South Orange County Medical Research Center	Laguna Hills	California
United States	Urological Association of Lancaster	Lancaster	Pennsylvania
United States	Lawrenceville Urology	Lawrenceville	New Jersey
United States	Atlantic Urology Medical Group	Long Beach	California
United States	Urology Enterprises	Marietta	Georgia
United States	Midwest Urology/RMD Clinical Research Institute	Melrose Park	Illinois
United States	Connecticut Clinical Research Center	Middlebury	Connecticut
United States	Carolina Urologic Research Center	Myrtle Beach	South Carolina
United States	Urology Associates	Nashville	Tennessee
United States	Grove Hill Medical Center	New Britain	Connecticut
United States	University Urology Associates	New York	New York
United States	Urology of Virginia	Norfolk	Virginia
United States	Winter Park Urology Associates	Orlando	Florida
United States	Nationsmed Clinical Research	Perth Amboy	New Jersey
United States	Hudson Valley Urology P.C.	Poughkeepsie	New York
United States	Virginal Urology	Richmond	Virginia
United States	Virginia Urology Center	Richmond	Virginia
United States	Lackland Air Force base	San Antonio	Texas
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	Seattle Urology Research Center	Seattle	Washington
United States	Regional Urology, Lic	Shreveport	Louisiana
United States	Roger D. Fincher, PS	Spokane	Washington
United States	State College Urologic Association	State College	Pennsylvania
United States	Southeastern Urology Center, PA	Tallahassee	Florida
United States	Tampa Bay Urology	Tampa	Florida
United States	Chesapeake Urology Associates, PA	Towson	Maryland
United States	Advanced Research Institute, Inc	Trinity	Florida
United States	Center for Urologic Care	Voorhees	New Jersey
United States	Walter Reed Army Hospital Medical Center	Washington	District of Columbia
United States	Lexington Urological Associates, PA	West Columbia	South Carolina
United States	Delaware Valley Urology LLC	Westampton	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
Ferring Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	PSA		Monthly	Yes
Secondary	1. Reported Outcome Quality of Life intermittent treatment & continuous treatment		Phase A Visit 1-7. Phase B Visit 8-15.	No
Secondary	2. PSA		Monthly	Yes