A Degarelix Trial in Patients With Prostate Cancer

This study has been terminated.
(Inadequate recruitment resulting in a too low patient number for collection of long term efficacy data.)
Sponsor:
Information provided by (Responsible Party):
Ferring Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT01242748
First received: November 16, 2010
Last updated: May 13, 2015
Last verified: May 2015
Results First Received: February 26, 2015  
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
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
All participants who completed the main CS35 trial after initiation of the CS35A extension trial were eligible to enrol into CS35A.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Participants entering the CS35A trial continued with the same 3-monthly treatment as they received in CS35 (i.e. degarelix 480 mg or goserelin 10.8 mg).

Reporting Groups
  Description
Degarelix 240 mg/480 mg Degarelix: The degarelix doses were administered by subcutaneous (s.c.) injections into the abdominal wall. In the main CS35 trial, 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 in the main trial). In the CS35A extension trial, the participants received the same treatment as in the main trial ie the degarelix treated participants continued to receive degarelix 480 mg s.c. treatment every three months.
Goserelin Acetate Goserelin acetate: The goserelin doses were administered by subcutaneous (s.c.) implants into the abdominal wall. In the main CS35 trial, 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 in the main trial). In the CS35A extension trial, the participants received the same treatment as in the main trial ie the goserelin treated participants continued to receive goserelin acetate 10.8 mg s.c. implants every three months.

Participant Flow:   Overall Study
    Degarelix 240 mg/480 mg     Goserelin Acetate  
STARTED     194 [1]   94  
CS35/CS35A Safety Analysis Set     565 [2]   283  
CS35/CS35A Full Analysis Set (FAS)     565 [3]   282  
COMPLETED     156 [4]   80  
NOT COMPLETED     38     14  
Adverse Event                 10                 5  
Lost to Follow-up                 6                 2  
Physician Decision                 3                 2  
Protocol Violation                 1                 0  
Withdrawal by Subject                 10                 2  
Miscellaneous reasons                 8                 3  
[1] Enrolled in CS35A, CS35A Full Analysis Set.
[2] Received at least 1 dose of trial drug during the main CS35 trial.
[3] Received at least 1 dose of trial drug during CS35+had at least 1 efficacy assessment after dosing.
[4] These participants were ongoing when the trial was closed by the Sponsor.



  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.
CS35A Full Analysis Set

Reporting Groups
  Description
Degarelix 240 mg/480 mg Degarelix: The degarelix doses were administered by subcutaneous (s.c.) injections into the abdominal wall. In the main CS35 trial, 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 in the main trial). In the CS35A extension trial, the participants received the same treatment as in the main trial ie the degarelix treated participants continued to receive degarelix 480 mg s.c. treatment every three months.
Goserelin Acetate Goserelin acetate: The goserelin doses were administered by subcutaneous (s.c.) implants into the abdominal wall. In the main CS35 trial, 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 in the main trial). In the CS35A extension trial, the participants received the same treatment as in the main trial ie the goserelin treated participants continued to receive goserelin acetate 10.8 mg s.c. implants every three months.
Total Total of all reporting groups

Baseline Measures
    Degarelix 240 mg/480 mg     Goserelin Acetate     Total  
Number of Participants  
[units: participants]
  194     94     288  
Age  
[units: years]
Mean (Standard Deviation)
  73.1  (8.4)     71.3  (7.0)     72.5  (8.0)  
Gender  
[units: participants]
     
Female     0     0     0  
Male     194     94     288  
Race (NIH/OMB)  
[units: participants]
     
American Indian or Alaska Native     34     21     55  
Asian     1     0     1  
Native Hawaiian or Other Pacific Islander     0     0     0  
Black or African American     5     5     10  
White     154     68     222  
More than one race     0     0     0  
Unknown or Not Reported     0     0     0  
Median Baseline Serum Testosterone Levels  
[units: nanogramĀ perĀ milliliterĀ (ng/mL)]
Median (Full Range)
  4.41   (0.68 to 13.3)     4.65   (1.55 to 13.2)     4.52   (0.68 to 13.3)  
Median Baseline Serum Prostate-specific Antigen Levels  
[units: ng/mL]
Median (Full Range)
  20.6   (0.4 to 8762)     16.6   (1.49 to 12961)     18.7   (0.4 to 12961)  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Hazard Ratio of Prostate-specific Antigen (PSA) Progression-free Survival (PFS) Failure Rates During 3 Years’ Treatment Between Degarelix and Goserelin   [ Time Frame: From baseline to 3 years ]

2.  Secondary:   Hazard Ratio of PFS Failure Rates During 3 Years Treatment Between Degarelix and Goserelin   [ Time Frame: From baseline to 3 years ]

3.  Secondary:   Hazard Ratio of PSA Failure Rates During 3 Years Treatment Between Degarelix and Goserelin   [ Time Frame: From baseline to 3 years ]

4.  Secondary:   Hazard Ratio of Testosterone Escape Rates During 3 Years’ Treatment Between Degarelix and Goserelin   [ Time Frame: From baseline to 3 years ]

5.  Secondary:   Hazard Ratio of the Rates of Introduction of Additional Therapy Related to Prostate Cancer During 3 Years’ Treatment Between Degarelix and Goserelin   [ Time Frame: From baseline to 3 years ]

6.  Secondary:   Hazard Ratio of Mortality Rates During 3 Years’ Treatment Between Degarelix and Goserelin   [ Time Frame: From baseline to 3 years ]

7.  Secondary:   Serum Levels of Testosterone During 3 Years’ Treatment With Degarelix or Goserelin   [ Time Frame: Baseline and after 1, 6, 12, 19, and 22 months ]

8.  Secondary:   Serum Levels of Prostate-specific Antigen (PSA) During 3 Years’ Treatment With Degarelix or Goserelin   [ Time Frame: Baseline and after 1, 6, 12, 19, and 22 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: NCT01242748     History of Changes
Other Study ID Numbers: FE200486 CS35A, 2010-021434-55
Study First Received: November 16, 2010
Results First Received: February 26, 2015
Last Updated: May 13, 2015
Health Authority: United States: Food and Drug Administration
Canada: Health Canada
Mexico: Ministry of Health
Belgium: Federal Agency for Medicinal Products and Health Products
Czech Republic: State Institute for Drug Control
Finland: Finnish Medicines Agency
Germany: Federal Institute for Drugs and Medical Devices
Hungary: National Institute of Pharmacy
Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Romania: National Medicines Agency
Ukraine: State Pharmacological Center - Ministry of Health
United Kingdom: Medicines and Healthcare Products Regulatory Agency