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

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 2

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

Resource links provided by NLM:

MedlinePlus related topics: Cancer Prostate Cancer

Drug Information available for: Degarelix

U.S. FDA Resources

Further study details as provided by Ferring Pharmaceuticals:

Primary Outcome Measures:

Number of Participants With Testosterone Level <=0.5 ng/mL From Day 28 Until the End of the Study [ Time Frame: From Day 28 to 12 or 13 months ] [ Designated as safety issue: No ]
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.

Secondary Outcome Measures:

Number of Participants With Testosterone Level <=0.5 ng/mL After the Dose at Day 28 Until the End of the Study [ Time Frame: From after Day 28 to 12 or 13 months ] [ Designated as safety issue: No ]
Figures in the table give the number of participants with all testosterone values <=0.5 ng/mL after the dose at Day 28 to end of study. Thus, the testosterone response after the initial dose is not included in this outcome measure.
Number of Participants With Testosterone <=0.5 ng/mL at Day 28 [ Time Frame: 28 Days ] [ Designated as safety issue: No ]
Figures in the table give number of participants with testosterone <=0.5 ng/mL 28 days after the initial dose of trial medication.
Liver Function Tests [ Time Frame: 12 or 13 months ] [ Designated as safety issue: No ]
The figures present the number of participants who had abnormal (defined as above upper limit of normal range (ULN)) alanine aminotransferase (ALT) levels, aspartate aminotransferase levels, and bilirubin levels plus the number of participants who had ALT increases >3x ULN and ALT increases >3x ULN with concurrently increased bilirubin >1.5 ULN.
Number of Participants With Markedly Abnormal Change in Vital Signs and Body Weight as Compared to Baseline [ Time Frame: 12 or 13 months ] [ Designated as safety issue: No ]
This outcome measure included incidence of markedly abnormal changes in blood pressure (systolic and diastolic), pulse, and body weight. The table presents the number of participants with normal baseline and at least one post-baseline markedly abnormal value.

Enrollment:	460
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
Active Comparator: Degarelix 240@40/240@40 (1,3,6,9) 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 240 mg (40 mg/mL) initiation dose, maintenance dose 240 mg (40 mg/mL) at months 1, 3, 6 and 9 Other Name: FE200486
Active Comparator: Degarelix 240@40/240@60(1,3,6,9) 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 240 mg (40 mg/mL) initiation dose, maintenance dose 240 mg (60 mg/mL) at months 1, 3, 6 and 9 Other Name: FE200486
Active Comparator: Degarelix 240@40/240@60(1,4,7,10) 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 240 mg (40 mg/mL) initiation dose, maintenance dose 240 mg (60 mg/mL) at months 1, 4, 7 and 10 Other Name: FE200486

Eligibility

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

Criteria

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 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 56 Study Locations

Sponsors and Collaborators

Ferring Pharmaceuticals

Investigators

Study Director:

Clinical Development Support

Ferring Pharmaceuticals

More Information

No publications provided

Responsible Party:	Clinical Development Support, Ferring Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00116753 History of Changes
Other Study ID Numbers:	FE200486 CS15
Study First Received:	June 30, 2005
Results First Received:	October 6, 2010
Last Updated:	November 12, 2010
Health Authority:	United States: Food and Drug Administration Canada: Health Canada

Keywords provided by Ferring Pharmaceuticals:

Prostate Cancer
Androgen ablation therapy

Additional relevant MeSH terms:

Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site

Neoplasms
Genital Diseases, Male
Prostatic Diseases

ClinicalTrials.gov processed this record on May 16, 2013