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A Parallel Group Comparison of the Efficacy and Safety of Degarelix at Two Different Dosing Regimens in Patients With Prostate Cancer

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Ferring Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00116779
First received: June 30, 2005
Last updated: December 15, 2011
Last verified: December 2011
History of Changes
Results First Received: January 22, 2009  
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
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
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
One hundred and seventy-six patients were screened to identify the one hundred and twenty-seven patients who were eligible for randomization.

Reporting Groups
  Description
Degarelix 60mg Initial dose of 200 milligrams of Degarelix on Day 0 (cycle 1) given by subcutaneous injection. Maintenance dose of 60 milligrams of Degarelix given by subcutaneous injection every 28 days for cycles 2-13.
Degarelix 80mg Initial dose of 200 milligrams of Degarelix on Day 0 (cycle 1) given by subcutaneous injection. Maintenance dose of 80 milligrams of Degarelix given by subcutaneous injection every 28 days for cycles 2 - 13.

Participant Flow:   Overall Study
    Degarelix 60mg     Degarelix 80mg  
STARTED     63 [1]   64 [1]
COMPLETED     42     45  
NOT COMPLETED     21     19  
Adverse Event                 4                 2  
Protocol Violation                 1                 4  
Withdrawal by Subject                 4                 1  
Inadequate testosterone suppression                 7                 9  
Physician Decision                 3                 1  
Elevated PSA levels                 2                 2  
[1] Randomized and treated; Intent-to-treat population



  Baseline Characteristics
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Reporting Groups
  Description
Degarelix 60mg Initial dose of 200 milligrams of Degarelix on Day 0 (cycle 1) given by subcutaneous injection. Maintenance dose of 60 milligrams of Degarelix given by subcutaneous injection every 28 days for cycles 2-13.
Degarelix 80mg Initial dose of 200 milligrams of Degarelix on Day 0 (cycle 1) given by subcutaneous injection. Maintenance dose of 80 milligrams of Degarelix given by subcutaneous injection every 28 days for cycles 2 - 13.
Total Total of all reporting groups

Baseline Measures
    Degarelix 60mg     Degarelix 80mg     Total  
Number of Participants  
[units: participants]
 		  63     64     127  
Age  
[units: participants]
 		     
<=18 years     0     0     0  
Between 18 and 65 years     9     9     18  
>=65 years     54     55     109  
Age  
[units: years]
Mean ± Standard Deviation 		  74.8  ± 8.73     74.9  ± 9.55     74.9  ± 9.12  
Gender  
[units: participants]
 		     
Female     0     0     0  
Male     63     64     127  
Race (NIH/OMB)  
[units: participants]
 		     
American Indian or Alaska Native     0     0     0  
Asian     1     1     2  
Native Hawaiian or Other Pacific Islander     0     0     0  
Black or African American     14     4     18  
White     48     59     107  
More than one race     0     0     0  
Unknown or Not Reported     0     0     0  
Curative Intent [1]
[units: participants]
 		     
No     41     40     81  
Yes     22     24     46  
Participant Counts by Gleason Score [2]
[units: participants]
 		     
2-4     3     3     6  
5-6     19     22     41  
7-10     41     39     80  
The Number of Participants at Each Stage of Prostate Cancer [3]
[units: participants]
 		     
Localized     31     23     54  
Locally advanced     5     9     14  
Metastatic     15     9     24  
Not classifiable     12     23     35  
Body Mass Index [4]
[units: kilogram per square meter]
Mean ( Full Range ) 		  27.3  
  ( 19.1 to 39.2 )   		  26.7  
  ( 16.9 to 36.4 )   		  27  
  ( 16.9 to 39.2 )  
Days Since Diagnosis of Prostate Cancer [5]
[units: days]
Mean ± Standard Deviation 		  1213  ± 1597     1256  ± 1550     1234  ± 1568  
Serum Prostate-Specific Antigen [6]
[units: nanograms/milliliter]
Median ( Full Range ) 		  12.7  
  ( 2.7 to 759 )   		  13.7  
  ( 1.6 to 1942 )   		  13.4  
  ( 1.6 to 1942 )  
Serum Testosterone level [7]
[units: nanograms/milliliter]
Median ( Full Range ) 		  4.1  
  ( 1.51 to 11 )   		  4.23  
  ( 0.2 to 8.68 )   		  4.13  
  ( 0.2 to 11 )  
Weight [8]
[units: Kilograms]
Mean ± Standard Deviation 		  83  ± 14.6     81.2  ± 12.7     82.1  ± 13.7  
[1] A curative intent of Yes refers to participants who have been castrated via radical prostatectomy or radiotherapy.
[2] 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.
[3] 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.
[4] Body mass index is a measure of body fat based on height and weight.
[5] The number of days passed since a diagnosis of prostate cancer was made for each participant.
[6] Prostate-specific antigen (PSA) is a protein produced by the cells of the prostate gland. The PSA test measures the level of PSA in the blood. High PSA levels have a postive corrolation to prostate cancer.
[7] Testosterone is a steroid hormone from the androgen group, and the principal male sex hormone. This test measures the amount of testosterone in the blood. Androgen deprivation is used to manage prostate cancer.
[8] Mean of Participants Weight in Kilograms



  Outcome Measures
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1.  Primary:   Number of Participants With Testosterone <=0.5 Nanogram/Milliliter From Day 28 to Day 364   [ Time Frame: Day 28 to Day 364 ]
  Show Outcome Measure 1

2.  Primary:   Number of Participants With Testosterone Level <= 0.5 Nanogram/Milliliter From Day 28 to Day 364 for Participants With Testosterone <= 0.5 Nanogram/Milliliter at Day 28   [ Time Frame: Day 28 - Day 364 ]
  Show Outcome Measure 2

3.  Secondary:   Number of Participants With Testosterone <= 0.5 Nanogram/Milliliter at Day 3.   [ Time Frame: Day 3 ]
  Show Outcome Measure 3

4.  Secondary:   Days to 50 Percent and 90 Percent Reduction in Prostate-Specific Antigen   [ Time Frame: Day 0 (post dose) to Day 364 ]
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5.  Secondary:   Days to Prostate-Specific Antigen Progression   [ Time Frame: Day 0 (post dose) to Day 364 ]
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6.  Secondary:   Median Di-Hydrotestosterone Levels At Various Study Timepoints   [ Time Frame: Baseline, Days 1, 3, 7, 14 ]
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7.  Secondary:   Median Prostate-Specific Antigen Values at Various Study Timepoints   [ Time Frame: Baseline, Days 3, 14, 28, 84, 364 ]
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8.  Secondary:   Median Luteinizing Hormone Levels at Various Study Timeframes   [ Time Frame: Baseline, Days 1, 3, 7, 14 ]
  Show Outcome Measure 8

9.  Secondary:   Median Testosterone Levels at Various Days During the Study   [ Time Frame: Baseline, Days 1,3,7,14,364 ]
  Show Outcome Measure 9

10.  Secondary:   Number of Participants With Abnormal Alanine Aminotransferase Values   [ Time Frame: Day 1 through day 364 ]
  Show Outcome Measure 10

11.  Secondary:   Number of Participants With Abnormal Aspartate Aminotransferase Values   [ Time Frame: Day 1 - 364 ]
  Show Outcome Measure 11

12.  Secondary:   Number of Participants With Abnormal Total Bilirubin Values   [ Time Frame: Day 1 - 364 ]
  Show Outcome Measure 12

13.  Secondary:   Participants With Markedly Abnormal Changes in Vital Signs or Body Weight   [ Time Frame: Day 364 ]
  Show Outcome Measure 13


  Serious Adverse Events
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  Other Adverse Events
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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.


Limitations and Caveats
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
No text entered.  


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


Publications of Results:


Responsible Party: Ferring Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00116779     History of Changes
Other Study ID Numbers: FE200486 CS14
Study First Received: June 30, 2005
Results First Received: January 22, 2009
Last Updated: December 15, 2011
Health Authority: United States: Food and Drug Administration
Canada: Health Canada