Know Cancer

forgot password

An Open-label Multi-center, Randomized Parallel Group Comparison of Efficacy and Safety of Degarelix Three-Month Depot in Three Different Dosing Regimens in Patients With Prostate Cancer

Phase 2
18 Years
Not Enrolling
Prostate Cancer

Thank you

Trial Information

An Open-label Multi-center, Randomized Parallel Group Comparison of Efficacy and Safety of Degarelix Three-Month Depot in Three Different Dosing Regimens in Patients With Prostate Cancer

Inclusion Criteria:

- Has given written consent before 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.

- Has a histologically confirmed (Gleason graded) 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 undergone
prostatectomy or radiotherapy with curative intention.

- Is a male patient aged 18 years or over.

- Has a baseline serum testosterone level above the lower limit of normal range,
globally defined as >2.2 ng/mL.

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

- Has a PSA value of 2 ng/mL.

- Has a life expectancy of at least 13 months.

Exclusion Criteria:

- Has had previous or is currently under hormonal management of prostate cancer
(surgical castration or other hormonal manipulation, e.g. GnRH agonists, GnRH
antagonists, antiandrogens, oestrogens). However, patients having undergone
prostatectomy or radiotherapy with curative intention, neoadjuvant hormonal therapy
is accepted for a maximal duration of 6 months. This treatment should have been
terminated at least 6 months prior to the Screening Visit.

- Is considered to be a candidate for curative therapy, i.e. radical prostatectomy or
radiotherapy within 13 months from Screening Visit.

- Has a history of, or predisposition to, severe hypersensitivity reactions such as
severe asthma (defined as a need for daily treatment with inhalation steroids to
control the asthma), anaphylactic reactions, or chronic or recurrent urticaria and/or

- Has hypersensitivity towards any component of the investigational medicinal product.
5. Has had a cancer disease within the last five years except for prostate cancer
and surgically removed basal or squamous cell carcinoma of the skin.

- Has a known or suspected hepatic or symptomatic biliary disease.

- Has elevated serum ALT level above upper level of normal range or serum total
bilirubin level above upper level of normal range as measured by the laboratory at
the Screening Visit.

- Has other clinically significant laboratory abnormalities, which in the judgment of
the investigator would interfere with the patient's participation 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 study
participation or which may affect the conclusion of the study as judged by the

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

- Has received an investigational drug within the last 28 days preceding Screening
Visit or longer if considered by the investigator to possibly influence the outcome
of the current study.

- Has previously participated in any degarelix study.

Type of Study:


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 Level <=0.5 ng/mL From Day 28 Until the End of the Study

Outcome Description:

Figure in the table give the number of participants with all testosterone values <=0.5 ng/mL from Day 28 to the end of the study.

Outcome Time Frame:

From Day 28 to 12 or 13 months

Safety Issue:


Principal Investigator

Clinical Development Support

Investigator Role:

Study Director

Investigator Affiliation:

Ferring Pharmaceuticals


United States: Food and Drug Administration

Study ID:

FE200486 CS15



Start Date:

January 2005

Completion Date:

November 2006

Related Keywords:

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



Advanced Urology Medical Center Anaheim, California  92801
Urology San Antonio Research San Antonio, Texas  78229
South Florida Medical Research Aventura, Florida  33180
Alaska Clinical Research Center, LLC Anchorage, Alaska  99508
Center for Urological Research La Mesa, California  91942
Kansas City Urology Care Kansas City, Missouri  64131
Grand Strand Urology Myrtle Beach, South Carolina  29572
Urology Centers Of Alabama Homewood,, Alabama  35205
Regional Urology Shreveport, Louisiana  71106
The Urology Center Greensboro,, North Carolina  27401
South Orange County Medical Research Center Laguna Hills, California  92653
Western Clinical Research Torrance, California  90505
Northeast Urology Research Concord, North Carolina  28025
Medical Affiliationed Research Center Huntsville, Alabama  35801
West Coast Clinical Research Tarzana, California  91356
Urology Research Option Aurora, Colorado  80012
SW Florida Urological Associates Fort Myers, Florida  33907
RT Services, Inc Ft Myers, Florida  33901
Mississippi Urology Clinic Jackson, Mississippi  39202
University of Missouri, Urology, Deptof Surgery Columbia, Missouri  65212
State College Urologic Association State College, Pennsylvania  16801
Urology Association of Northern Texas Fort Worth, Texas  76104
Seatle Urology Research Centre Seattle, Washington  98166