A Comparative Study of Degarelix Three-Month Depot in Three Different Dosing Regimens in Patients With Prostate Cancer - Full Text View

Sponsored by:	Ferring Pharmaceuticals
Information provided by:	Ferring Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00116753

Purpose

The rationale of the study was to evaluate different degarelix dosing regimens for a three-month interval that was to produce and maintain castration in prostate cancer patients through immediate and prolonged testosterone suppression, and to provide confirmatory evidence of the safety of degarelix.

Condition	Intervention	Phase
Prostate Cancer	Drug: Degarelix	Phase II

MedlinePlus related topics: Cancer Prostate Cancer

Drug Information available for: Degarelix

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Dose Comparison, Parallel Assignment, Safety/Efficacy Study
Official Title:	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

Further study details as provided by Ferring Pharmaceuticals:

Primary Outcome Measures:

To demonstrate the efficacy of Degarelix [ Time Frame: 1 Year ]

Secondary Outcome Measures:

To demonstrate the pharmacokinetics and safety of Degarelix [ Time Frame: 1year ]

Enrollment:	447
Study Start Date:	January 2005
Study Completion Date:	November 2006
Primary Completion Date:	November 2006 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator 240 mg (40 mg/mL) initiation dose, maintenance dose 240 mg (40 mg/mL) at months 1,3, 6 and 9	Drug: Degarelix Drug: Degarelix subcutaneous A: 240 mg (40 mg/mL) initiation dose, maintenance dose 240 mg (40 mg/mL) at months 1,3, 6 and 9 B: 240 mg (40 mg/mL) initiation dose, maintenance dose 240 mg (60 mg/mL) at months 1,3, 6 and 9 C: 240 mg (40 mg/mL) initiation dose, maintenance dose 240 mg (60 mg/mL) at months 1,4, 7 and 10
2: Active Comparator 240 mg (40 mg/mL) initiation dose, maintenance dose 240 mg (60 mg/mL) at months 1,3, 6 and 9	Drug: Degarelix Drug: Degarelix subcutaneous A: 240 mg (40 mg/mL) initiation dose, maintenance dose 240 mg (40 mg/mL) at months 1,3, 6 and 9 B: 240 mg (40 mg/mL) initiation dose, maintenance dose 240 mg (60 mg/mL) at months 1,3, 6 and 9 C: 240 mg (40 mg/mL) initiation dose, maintenance dose 240 mg (60 mg/mL) at months 1,4, 7 and 10
3: Active Comparator 240 mg (40 mg/mL) initiation dose, maintenance dose 240 mg (60 mg/mL) at months 1,4, 7 and 10	Drug: Degarelix Drug: Degarelix subcutaneous A: 240 mg (40 mg/mL) initiation dose, maintenance dose 240 mg (40 mg/mL) at months 1,3, 6 and 9 B: 240 mg (40 mg/mL) initiation dose, maintenance dose 240 mg (60 mg/mL) at months 1,3, 6 and 9 C: 240 mg (40 mg/mL) initiation dose, maintenance dose 240 mg (60 mg/mL) at months 1,4, 7 and 10

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

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

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:

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

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00116753

Show 24 Study Locations

Sponsors and Collaborators

Ferring Pharmaceuticals

Investigators

Study Director:

Clinical Development Support

Ferring Pharmaceuticals

More Information

No publications provided

Responsible Party:	Ferring Pharmaceuticals ( Hjort, Director )
Study ID Numbers:	FE200486 CS15
Study First Received:	June 30, 2005
Last Updated:	February 20, 2009
ClinicalTrials.gov Identifier:	NCT00116753 History of Changes
Health Authority:	United States: Food and Drug Administration; Canada: Health Canada

Keywords provided by Ferring Pharmaceuticals:

Prostate Cancer
Androgen ablation therapy

Study placed in the following topic categories:

Prostatic Diseases
Genital Neoplasms, Male
Urogenital Neoplasms

Genital Diseases, Male
Prostatic Neoplasms
Androgens

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Site
Prostatic Diseases
Genital Neoplasms, Male

Urogenital Neoplasms
Genital Diseases, Male
Prostatic Neoplasms

ClinicalTrials.gov processed this record on May 07, 2009