A Trial of Degarelix in Patients With Prostate Cancer

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Ferring Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00946920
First received: July 3, 2009
Last updated: May 2, 2014
Last verified: May 2014
Results First Received: February 14, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Prostate Cancer
Interventions: Drug: Degarelix
Drug: Goserelin acetate

  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
Subjects who met the eligibility criteria were randomized to degarelix or goserelin acetate treatment in a 2:1-ratio. 859 subjects were randomized but 11 subjects did not receive any treatment.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Degarelix 240 mg/480 mg Degarelix: The degarelix doses were administered by subcutaneous (s.c.) injections into the abdominal wall. A starting dose of 240 mg degarelix was administered on Day 0. One month later a maintenance dose of 480 mg was administered. This was repeated after 4, 7, and 10 months (ie a total of 5 administrations).
Goserelin Acetate Goserelin acetate: The goserelin doses were administered by subcutaneous (s.c.) implants into the abdominal wall. An initial dose of 3.6 mg goserelin was administered on Day 0. One month later a subsequent dose of 10.8 mg was administered and this was repeated after 4, 7, and 10 months (ie a total of 5 implants).

Participant Flow:   Overall Study
    Degarelix 240 mg/480 mg     Goserelin Acetate  
STARTED     565 [1]   283 [2]
Full Analysis Set (FAS)     565 [3]   282 [4]
COMPLETED     455     239  
NOT COMPLETED     110     44  
Withdrawal by Subject                 28                 15  
Lost to Follow-up                 2                 2  
Physician Decision                 5                 2  
Adverse Event                 41                 14  
Protocol Violation                 16                 8  
Miscellaneous reasons                 18                 3  
[1] Received at least one dose of degarelix.
[2] Received at least one dose of goserelin acetate.
[3] Received at least one dose of degarelix and had at least one post-dosing efficacy assessment.
[4] Received at least one dose of goserelin and had at least one post-dosing efficacy assessment.



  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.
FAS

Reporting Groups
  Description
Degarelix 240 mg/480 mg Degarelix: The degarelix doses were administered by subcutaneous (s.c.) injections into the abdominal wall. A starting dose of 240 mg degarelix was administered on Day 0. One month later a maintenance dose of 480 mg was administered. This was repeated after 4, 7, and 10 months (ie a total of 5 administrations).
Goserelin Acetate Goserelin acetate: The goserelin doses were administered by subcutaneous (s.c.) implants into the abdominal wall. An initial dose of 3.6 mg goserelin was administered on Day 0. One month later a subsequent dose of 10.8 mg was administered and this was repeated after 4, 7, and 10 months (ie a total of 5 implants).
Total Total of all reporting groups

Baseline Measures
    Degarelix 240 mg/480 mg     Goserelin Acetate     Total  
Number of Participants  
[units: participants]
  565     282     847  
Age  
[units: years]
Mean ± Standard Deviation
  71.9  ± 8.3     71.1  ± 7.9     71.6  ± 8.2  
Gender  
[units: participants]
     
Female     0     0     0  
Male     565     282     847  
Race (NIH/OMB)  
[units: participants]
     
American Indian or Alaska Native     45     25     70  
Asian     4     1     5  
Native Hawaiian or Other Pacific Islander     0     1     1  
Black or African American     41     16     57  
White     475     239     714  
More than one race     0     0     0  
Unknown or Not Reported     0     0     0  
Median Baseline Serum Testosterone Levels (ng/mL)  
[units: ng/mL]
Median ( Full Range )
  4.52  
  ( 0.56 to 14.5 )  
  4.62  
  ( 0.07 to 13.2 )  
  4.54  
  ( 0.07 to 14.5 )  
Median Baseline Serum Prostate-specific Antigen Levels (ng/mL)  
[units: ng/mL]
Median ( Full Range )
  19.0  
  ( 0.26 to 8762 )  
  19.1  
  ( 0.01 to 12961 )  
  19.0  
  ( 0.01 to 12961 )  
Baseline Short Form-36 (SF-36) Total Scores [1]
[units: units on a scale]
Mean ± Standard Deviation
  49.7  ± 11.5     50.2  ± 11.4     49.9  ± 11.4  
Baseline Total International Prostate Symptom Scores (IPSS) [2]
[units: units on a scale]
Mean ± Standard Deviation
  11.8  ± 7.93     11.6  ± 8.02     11.7  ± 7.96  
[1] The SF-36 is a multi-purpose, short-form health survey with only 36 questions and with a minimum score of 0 and a maximum score of 100. The higher score the better health. It yields an 8-scale profile of functional health and well-being scores as well as psychometrically-based physical and mental health summary measures and a preference-based health utility index. The SF-36 has proven useful in surveys of general and specific populations, comparing the relative burden of diseases, and in differentiating the health benefits produced by a wide range of different treatments.
[2] IPSS is used to assess severity of lower urinary tract symptoms and to monitor the progress of symptoms once treatment has been initiated. It contains 7 questions regarding incomplete emptying, frequency, intermittency, urgency, weak stream, straining, and nocturia. Each question is assigned a score of 0-5 (i.e. the minimum total score is 0 and the maximum is 35). A score of “0” corresponds to a response of “not at all” for the first six symptoms and “none” for nocturia, and a score of 5 corresponds to a response of “almost always” for the first six symptoms and “5 times or more” for nocturia.



  Outcome Measures
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1.  Primary:   Cumulative Probability of Testosterone at Castrate Level (≤0.5 ng/mL) With Degarelix   [ Time Frame: From Day 28 to Day 364 ]

2.  Primary:   Difference in Cumulative Probability of Testosterone at Castrate Level (≤0.5 ng/mL) Between Degarelix and Goserelin   [ Time Frame: Day 3 to Day 364 ]

3.  Secondary:   Serum Levels of Testosterone Over Time   [ Time Frame: Baseline and after 1, 2, 3, 6 and 13 months ]

4.  Secondary:   Percent Change in Serum Levels of Prostate-specific Antigen (PSA) Over Time   [ Time Frame: Baseline and after 1, 2, 3, 6 and 13 months ]

5.  Secondary:   Change in Health-related Quality of Life (HRQoL), as Measured by Short Form-36 (SF-36) Score at Month 10 and Month 13 Compared to Baseline   [ Time Frame: At baseline, 10 months and 13 months ]

6.  Secondary:   Change in International Prostate Symptom Score (IPSS) Score at Months 1, 4, 7, and 13 Compared to Baseline   [ Time Frame: At baseline, 1 month, 4 months, 7 months and 13 months ]


  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: Clinical Development Support
Organization: Ferring Pharmaceuticals
e-mail: DK0-Disclosure@ferring.com


No publications provided


Responsible Party: Ferring Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00946920     History of Changes
Other Study ID Numbers: FE200486 CS35, 2008-005276-27
Study First Received: July 3, 2009
Results First Received: February 14, 2014
Last Updated: May 2, 2014
Health Authority: United States: Food and Drug Administration
Canada: Health Canada
Mexico: Ministry of Health
Belgium: Federal Agency for Medicines and Health Products, FAMHP
Finland: Finnish Medicines Agency
Germany: Ministry of Health
Netherlands: Ministry of Health, Welfare and Sport
United Kingdom: National Health Service
Czech Republic: State Institute for Drug Control
Hungary: National Institute of Pharmacy
Poland: Ministry of Health
Romania: National Medicines Agency
Russia: Ministry of Health of the Russian Federation
Ukraine: Ministry of Health