Extension Study Investigating the Long-Term Safety of Degarelix Three-Month Depots in Patients With Prostate Cancer

This study has been completed.
Sponsor:
Information provided by:
Ferring Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00268892
First received: December 21, 2005
Last updated: December 8, 2010
Last verified: December 2010
Results First Received: November 17, 2010  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Prostate Cancer
Intervention: Drug: Degarelix

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Participants who completed the main FE200486 CS15(NCT00113753) study (except those in US and Canada) were asked to continue into the FE200486 CS15A extension study.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
447 participants started and 374 participants completed the main CS15 study. Of these, 278 participants were recruited into the extension study CS15A and 203 participants signed the informed consent for dose shift.

Reporting Groups
  Description
Degarelix 240/240@40(1-3-6-9) Participants in this arm who completed the main study continued with the same dose (240 mg (40 mg/mL) starting dose and 240 mg (40 mg/mL) at months 1, 3, 6, and 9) in the extension study (240 mg (40 mg/mL) every three months). A protocol amendment in June 2006 changed the dosage to 360 mg or 480 mg (60 mg/mL).
Degarelix 240/240@60(1-3-6-9) Participants in this arm who completed the main study continued with the same dose (240 mg (40 mg/mL) starting dose and 240 mg (60 mg/mL) at months 1, 3, 6, and 9) in the extension study (240 mg (60 mg/mL) every three months). A protocol amendment in June 2006 changed the dosage to 360 mg or 480 mg (60 mg/mL).
Degarelix 240/240@60(1-4-7-10) Participants in this arm who completed the main study continued with the same dose (240 mg (40 mg/mL) starting dose and 240 mg (60 mg/mL) at months 1, 4, 7, 10) in the extension study (240 mg (60 mg/mL) every three months). A protocol amendment in June 2006 changed the dosage to 360 mg or 480 mg (60 mg/mL).

Participant Flow:   Overall Study
    Degarelix 240/240@40(1-3-6-9)     Degarelix 240/240@60(1-3-6-9)     Degarelix 240/240@60(1-4-7-10)  
STARTED     90     95     93  
Switched to Higher Dose     59     68     76  
COMPLETED     51     53     54  
NOT COMPLETED     39     42     39  
Adverse Event                 14                 17                 20  
Lack of Efficacy                 1                 3                 0  
Withdrawal by Subject                 14                 15                 13  
Physician Decision                 0                 1                 0  
Lost to Follow-up                 5                 2                 4  
Protocol Violation                 0                 1                 0  
Disease Progression                 1                 1                 0  
Trial Site Closed                 4                 2                 2  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Degarelix 240/240@40(1-3-6-9) Participants in this arm who completed the main study continued with the same dose (240 mg (40 mg/mL) starting dose and 240 mg (40 mg/mL) at months 1, 3, 6, and 9) in the extension study (240 mg (40 mg/mL) every three months). A protocol amendment in June 2006 changed the dosage to 360 mg or 480 mg (60 mg/mL).
Degarelix 240/240@60(1-3-6-9) Participants in this arm who completed the main study continued with the same dose (240 mg (40 mg/mL) starting dose and 240 mg (60 mg/mL) at months 1, 3, 6, and 9) in the extension study (240 mg (60 mg/mL) every three months). A protocol amendment in June 2006 changed the dosage to 360 mg or 480 mg (60 mg/mL).
Degarelix 240/240@60(1-4-7-10) Participants in this arm who completed the main study continued with the same dose (240 mg (40 mg/mL) starting dose and 240 mg (60 mg/mL) at months 1, 4, 7, 10) in the extension study (240 mg (60 mg/mL) every three months). A protocol amendment in June 2006 changed the dosage to 360 mg or 480 mg (60 mg/mL).
Total Total of all reporting groups

Baseline Measures
    Degarelix 240/240@40(1-3-6-9)     Degarelix 240/240@60(1-3-6-9)     Degarelix 240/240@60(1-4-7-10)     Total  
Number of Participants  
[units: participants]
  90     95     93     278  
Age [1]
[units: years]
Mean ± Standard Deviation
  72.7  ± 6.55     73.3  ± 7.00     71.8  ± 7.05     72.6  ± 6.88  
Gender [1]
[units: participants]
       
Female     0     0     0     0  
Male     90     95     93     278  
Race (NIH/OMB) [1]
[units: participants]
       
American Indian or Alaska Native     0     0     1     1  
Asian     0     1     1     2  
Native Hawaiian or Other Pacific Islander     0     0     0     0  
Black or African American     3     5     3     11  
White     87     89     88     264  
More than one race     0     0     0     0  
Unknown or Not Reported     0     0     0     0  
Body Weight [1]
[units: kilogram]
Mean ± Standard Deviation
  76.7  ± 13.0     76.9  ± 12.2     76.5  ± 12.8     76.7  ± 12.6  
Body Mass Index [1]
[units: kilogram per square meter]
Mean ± Standard Deviation
  25.4  ± 4.14     25.8  ± 3.93     25.8  ± 4.16     25.7  ± 4.07  
Curative Intent [2]
[units: participants]
       
Yes     10     12     7     29  
No     80     83     86     249  
Gleason Score [3]
[units: participants]
       
2-4     13     6     13     32  
5-6     33     30     34     97  
7-10     44     58     46     148  
Stage of Prostate Cancer [4]
[units: participants]
       
Localized     34     37     36     107  
Locally Advanced     26     26     28     80  
Metastatic     16     19     20     55  
Not Classifiable     14     13     9     36  
Time since Prostate Cancer Diagnosis [1]
[units: days]
Mean ± Standard Deviation
  469  ± 1079     347  ± 824     255  ± 583     356  ± 852  
[1] Safety analysis set.
[2] Safety analysis set. A curative intent of Yes refers to participants who have been castrated via radical prostatectomy or radiotherapy.
[3] Safety analysis set. The Gleason score is a system of grading the aggressiveness of the prostate cancer and how fast it is likely to grow and spread. Scale is 2-10, with low numbers being the least aggressive and 10 being the most aggressive. A Gleason Score was missing for one participant in the Degarelix 240/240@60(1-3-6-9) group.
[4] Safety analysis set. Prostate cancer stage was classified to describe the extent of cancer. Localized refers to tumors without involvement of lymph nodes or metastasis. Advanced localized can be larger tumors that may involve the lymph nodes but no metastasis. Metastatic are more advanced cancers that are spreading beyond the original tumor.



  Outcome Measures
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1.  Primary:   Number of Participants With Markedly Abnormal Values in Vital Signs and Body Weight   [ Time Frame: Baseline and up to 4.5 years ]

2.  Primary:   Liver Function Tests   [ Time Frame: 4.5 years ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Ferring Pharmaceuticals
Organization: Clinical Development Support
e-mail: DK0-Disclosure@ferring.com


No publications provided


Responsible Party: Clinical Development Support, Ferring Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00268892     History of Changes
Other Study ID Numbers: FE200486 CS15A
Study First Received: December 21, 2005
Results First Received: November 17, 2010
Last Updated: December 8, 2010
Health Authority: United States: Food and Drug Administration
Canada: Health Canada
Russia: Ethics Committee
Russia: FSI Scientific Center of Expertise of Medical Application
Russia: Ministry of Health of the Russian Federation
Russia: Pharmacological Committee, Ministry of Health
Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
Netherlands: Medical Ethics Review Committee (METC)
Netherlands: Independent Ethics Committee
Belgium: Federal Agency for Medicines and Health Products, FAMHP
Belgium: Institutional Review Board
France: Ministry of Health
France: National Consultative Ethics Committee for Health and Life Sciences
Romania: Ministry of Public Health
Romania: National Authority for Scientific Research
Romania: National Medicines Agency
United Kingdom: Medicines and Healthcare Products Regulatory Agency
United Kingdom: Research Ethics Committee
Germany: Ministry of Health
Germany: Ethics Commission
Finland: Ethics Committee
Finland: Finnish Medicines Agency
Serbia and Montenegro: Agency for Drugs and Medicinal Devices
Serbia: Ethics Committee