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An Open-Label, Multi-Centre, Randomised, Parallel-Arm One-Year Trial, Comparing the Efficacy and Safety of Degarelix Three-Month Dosing Regimen With Goserelin Acetate in Patients With Prostate Cancer Requiring Androgen Deprivation Therapy


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

Thank you

Trial Information

An Open-Label, Multi-Centre, Randomised, Parallel-Arm One-Year Trial, Comparing the Efficacy and Safety of Degarelix Three-Month Dosing Regimen With Goserelin Acetate in Patients With Prostate Cancer Requiring Androgen Deprivation Therapy


Inclusion Criteria:



- 18 years or older.

- Has a histological confirmed prostate cancer Gleason graded).

- Has a screening testosterone above 2.2 ng/mL.

- Rising PSA.

- Has Eastern Cooperative Oncology Group (ECOG) score of ≤ 2.

- Has a life expectancy of at least one year.

Exclusion Criteria:

- Current or previous hormone therapy.

- Has received therapy with finasteride and dutasteride within 12 weeks and 25 weeks,
respectively, prior to screening.

- Has a history of severe untreated asthma, anaphylactic reactions, or severe urticaria
and/or angioedema.

- Has a heart insufficiency.

- Has a previous history or presence of another malignancy, other than prostate cancer
or treated squamous/basal cell carcinoma of the skin, within the last five years.

- 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 received an investigational drug within the last 28 days before the Screening
Visit or longer if considered to possibly influencing the outcome of the current
trial.

- Is candidate for curative therapy, i.e. radical prostatectomy or radiotherapy.

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:

Testosterone level

Outcome Time Frame:

Every month during one year of treatment

Safety Issue:

No

Principal Investigator

Clinical Development Support

Investigator Role:

Study Director

Investigator Affiliation:

Ferring Pharmaceuticals

Authority:

United States: Food and Drug Administration

Study ID:

FE200486 CS35

NCT ID:

NCT00946920

Start Date:

June 2009

Completion Date:

March 2011

Related Keywords:

  • Prostate Cancer
  • Prostatic Neoplasms

Name

Location

Walter Reed Army Medical CenterWashington, District of Columbia  20307-5000
Urology San Antonio ResearchSan Antonio, Texas  78229
Virginia Urology CenterRichmond, Virginia  23230
Duke University Medical CenterDurham, North Carolina  27710
South Florida Medical ResearchAventura, Florida  33180
Urology Associates of Central CAFresno, California  93720
Florida Foundation for Healthcare ResearchOcala, Florida  34474
Grand Strand UrologyMyrtle Beach, South Carolina  29572
Urology Centers Of AlabamaHomewood,, Alabama  35205
South Orange County Medical Research CenterLaguna Hills, California  92653
Atlantic Urology Medical GroupLong Beach, California  90806
Lawrenceville UrologyLawrenceville, New Jersey  08648
Arkansas UrologyLittle Rock, Arkansas  72211
Northeast Urology ResearchConcord, North Carolina  28025
State College Urologic AssociationState College, Pennsylvania  16801
Hamilton Urology PAHamilton, New Jersey  08690
MedResearchLa Mesa, California  91942
Seattle Urology Research CenterBurien, Washington  
The Urology Center of ColoradoDenver, Colorado  80211
Urology of VirginiaNewport News, Virginia  23606
Alliance Urology SpecialistsGreensboro, North Carolina  27403
Urology Clinics of North Texas, PADallas, Texas  75231
Indiana University Department of UrologyIndianapolis, Indiana  46202
Hudson Valley Urology P.C.Poughkeepsie, New York  
Anschutz Cancer PavillionAurora, Colorado  
Urological Associates of Bridgeport, P.C.Trumbull, Connecticut  
Urology Associates of Dover, PADover, Delaware  
Georgis Patsias, MD, PAWellington, Florida  
Palm Beach Urology Associates, PAWellington, Florida  
Kansas City Urology Care, PAOverland Park, Kansas  
Urological Associates of EnglewoodEnglewood, New Jersey  
Urology Group of New Mexico, PCAlbuquerque, New Mexico  
Capital Region Urological Surgeons and Research AssociatesAlbany, New York  
Metrolina Urology ClinicCharlotte, North Carolina  
Urologic Consultants of SEPABala Cynwyd, Pennsylvania