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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


Phase 3
18 Years
N/A
Not Enrolling
Male
Prostate Cancer

Thank you

Trial Information

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


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.

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

PSA

Outcome Time Frame:

Monthly

Safety Issue:

Yes

Principal Investigator

Clinical Development Support

Investigator Role:

Study Director

Investigator Affiliation:

Ferring Pharmaceuticals

Authority:

United States: Food and Drug Administration

Study ID:

FE200486 CS37

NCT ID:

NCT00928434

Start Date:

May 2009

Completion Date:

September 2012

Related Keywords:

  • Prostate Cancer
  • Prostatic Neoplasms

Name

Location

Advanced Urology Medical CenterAnaheim, California  92801
Virginia Urology CenterRichmond, Virginia  23230
University of Colorado Health Sciences CenterDenver, Colorado  80262
University of FloridaGainesville, Florida  32610-0277
South Florida Medical ResearchAventura, Florida  33180
Medical & Clinical Research AssociatesBay Shore, New York  11706
Connecticut Clinical Research CenterWaterbury, Connecticut  06708-2652
Northeast Indiana ResearchFort Wayne, Indiana  46804-4128
Winter Park Urology AssociatesOrlando, Florida  32803
Urology AssociatesNashville, Tennessee  37209
South Orange County Medical Research CenterLaguna Hills, California  92653
Urology Associates Of Central CaliforniaFresno, California  93720
Atlantic Urology Medical GroupLong Beach, California  90806
Lawrenceville UrologyLawrenceville, New Jersey  08648
Center for Urologic CareVoorhees, New Jersey  08043
San Bernardino Urological AssociatesSan Bernardino, California  
San Diego Uro-ResearchSan Diego, California  92101
Northeast Urology ResearchConcord, North Carolina  28025
Carolina Urologic Research CenterMyrtle Beach, South Carolina  29572
Chesapeake Urology AssociatesBaltimore, Maryland  21204
Metropolitan Urology, PSCJeffersonville, Indiana  47130
State College Urologic AssociationState College, Pennsylvania  16801
Tampa Bay UrologyTampa, Florida  33607
Urology EnterprisesMarietta, Georgia  30060
Hamilton Urology PAHamilton, New Jersey  08690
University Urology AssociatesNew York, New York  10016
Chesapeake Urology Research AssociatesTowson, Maryland  21204
Urology Associates ResearchEnglewood, Colorado  
Seattle Urology Research CenterBurien, Washington  
The Urology Center of ColoradoDenver, Colorado  80211
Urology of VirginiaNewport News, Virginia  23606
Midwest Urology/RMD Clinical Research InstituteMelrose Park, Illinois  60160
Alliance Urology SpecialistsGreensboro, North Carolina  27403
Alabama Clinical Research, IncAlexander City, Alabama  
Urology Center of Alabama, PCHomewood, Alabama  
Peninsula Urology Medical CenterAtherton, California  
Santa Barbara Clinical ResearchSanta Barbara, California  
Grove Hill Medical CenterNew Britain, Connecticut  
Walter Reed Army Hospital Medical CenterWashington, District of Columbia  
Urology Health Solutions, IncCelebration, Florida  
Florida Urology PhysiciansFort Myers, Florida  
Southeastern Urology Center, PATallahassee, Florida  
Advanced Research Institute, IncTrinity, Florida  
Deaconess Clinic IncEvansville, Indiana  
Regional Urology, LicShreveport, Louisiana  
Myron Murdock M.D. LLCGreenbelt, Maryland  
Chesapeake Urology Associates, PATowson, Maryland  
Urology Associates of EnglewoodEnglewood, New Jersey  
Nationsmed Clinical ResearchPerth Amboy, New Jersey  
Delaware Valley Urology LLCWestampton, New Jersey  
The Urological Institute of NE NY, CCPAlbany, New York  
Brooklyn Heights Urology Associates, P.C.Brooklyn, New York  
Hudson Valley Urology P.C.Poughkeepsie, New York  
Urological Association of LancasterLancaster, Pennsylvania  
Lexington Urological Associates, PAWest Columbia, South Carolina  
Lackland Air Force baseSan Antonio, Texas  
Virginal UrologyRichmond, Virginia  
Roger D. Fincher, PSSpokane, Washington