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An Open-label, Randomized, Multi-center, Parallel Group Comparison of the Efficacy and Safety of Degarelix at Two Different Dosing Regimens in Patients With Prostate Cancer Dosed for Thirteen 28-day Cycles


Phase 2
18 Years
N/A
Not Enrolling
Male
Prostate Cancer

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Trial Information

An Open-label, Randomized, Multi-center, Parallel Group Comparison of the Efficacy and Safety of Degarelix at Two Different Dosing Regimens in Patients With Prostate Cancer Dosed for Thirteen 28-day Cycles


Inclusion Criteria:



Each patient must meet the following inclusion criteria before entry into the study.

- Has given written consent prior to any study-related activity is performed (a
study-related activity is defined as any procedure that would not have been performed
during the normal management of the patient).

- Histologically confirmed adenocarcinoma of the prostate (all stages), in whom
endocrine treatment (except for neoadjuvant hormonal therapy) is indicated. This
includes patients with rising PSA after having received radical prostatectomy
(removal of the entire prostate and seminal vesicles) or radiotherapy with curative
intention.

- Male patient aged 18 years or over.

- Has a baseline testosterone above the lower limit of normal range.

- Has an ECOG (Eastern Co-operative Oncology Group) score equal to or less than 2.

- Has a PSA value of greater than or equal to 2ng/mL.

Exclusion Criteria:

Any patient meeting one or more of the following exclusion criteria will not be entered
into the study.

- Previous or present hormonal management of prostate cancer (surgical castration or
other hormonal manipulation, e.g. GnRH agonists, GnRH antagonists, antiandrogens,
estrogens). However, patients having undergone neoadjuvant hormonal therapy in
conjunction with prostatectomy or radiotherapy with curative intention may be
included so long as the hormonal therapy did not exceed a total duration of 6 months
and was terminated at least 6 months prior to the Screening Visit.

- Currently or recently (within the last 12 weeks preceding the Screening Visit) under
treatment with any other drug modifying testosterone level or function.

- Is considered to be a candidate for curative therapy, i.e., radical prostatectomy or
radiotherapy within 6 months from Screening Visit.

- Has a history of severe asthma (defined as a need for daily treatment with oral or
inhalation steroids to control the asthma), anaphylactic reactions, angioedema,
angioneurotic edema or Quincke's Edema.

- Has hypersensitivity towards any component of the investigational products (degarelix
or mannitol).

- Has history of other cancer within the last 5 years except for prostate cancer and
surgically removed basal or squamous cell carcinoma of the skin.

- Has elevated serum ALT level more than three times above upper level of normal range
or serum total bilirubin level above one and a half times above upper level of normal
range as measured by the laboratory at the Screening Visit.

- Has known or suspect hepatic disease of any sort. Patients with liver disease are
not to be enrolled in this study.

- Has other clinically significant laboratory abnormalities, which in the judgment of
the investigator would interfere with the participation of the patient in this study
or evaluation of study results.

- Has a clinically significant disorder (other than prostate cancer) or any other
condition, including excessive alcohol or drug abuse, which may interfere with trial
participation or which may affect the conclusion of the study as judged by the
investigator.

- Has a mental incapacity or language barriers precluding adequate understanding or
cooperation.

- Has received an investigational drug within the last 12 weeks preceding Screening
Visit.

- Has previously participated in any degarelix study

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:

Number of Participants With Testosterone <=0.5 Nanogram/Milliliter From Day 28 to Day 364

Outcome Description:

Number of participants with all testosterone values <=0.5 nanogram/milliliter from Day 28 to Day 364

Outcome Time Frame:

Day 28 to Day 364

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 CS14

NCT ID:

NCT00116779

Start Date:

February 2004

Completion Date:

August 2005

Related Keywords:

  • Prostate Cancer
  • Prostate Cancer
  • Androgen ablation therapy
  • Prostatic Neoplasms

Name

Location

Advanced Urology Medical CenterAnaheim, California  92801
Urology San Antonio ResearchSan Antonio, Texas  78229
Virginia Urology CenterRichmond, Virginia  23230
South Florida Medical ResearchAventura, Florida  33180
Pacific Clinical ResearchSanta Monica, California  90404
Alaska Clinical Research Center, LLCAnchorage, Alaska  99508
Florida Foundation for Healthcare ResearchOcala, Florida  34474
Urology Centers Of AlabamaHomewood,, Alabama  35205
Regional UrologyShreveport, Louisiana  71106
The Urology CenterGreensboro,, North Carolina  27401
Scott & White Memorial HospitalTemple,, Texas  76508
Wyoming Research FoundationCheyenne, Wyoming  82001
Nevada Urology AssociatesReno, Nevada  89511
Northeast Indiana Research, LLCFort Wayne, Indiana  46825-1675
Lawrenceville UrologyLawrenceville, New Jersey  08648
Western Clinical ResearchTorrance, California  90505
West Coast Clinical ResearchTarzana, California  91356
SW Florida Urological AssociatesFort Myers, Florida  33907
State College Urologic AssociationState College, Pennsylvania  16801
South Orange County Medical Research CnterLaguna Woods,, California  92653
Urology Associate PCDenver, Colorado  80210
RMD Clinical Reseach Institution LLCMelrose Park, Illinois  60160
Hudson Valley Urology PCPoughkeepsie, New York  12601
Univeristy Urological Research InstituteProvidence, Rhode Island  02904
University of Vermont, Dept of SurgerySouth Burlington, Vermont  05403
Office of Jeffrey FrankelSeattle, Washington  98166