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The Efficacy and Safety of FE 200486 in Treatment of Patients Suffering From Prostate Cancer

This study has been completed.
Sponsor:
Information provided by:
Ferring Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00819247
First received: January 7, 2009
Last updated: May 18, 2011
Last verified: May 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 fifty-nine participants were screened. One hundred and twenty-nine participants were randomised, two of these participants withdrew before receiving any treatment.

Reporting Groups
  Description
Degarelix 80/80 + 40 Loading doses of Degarelix 80 mg on Days 0 and 3. Maintenance doses of 40 mg given on days 28, 56, 84, 112 and 140.
Degarelix 40/40 + 40 Loading doses of Degarelix 40 mg on Days 0 and 3. Maintenance doses of 40 mg given on days 28, 56, 84, 112 and 140.
Degarelix 80 + 20 Loading dose of Degarelix 80 mg on Day 0. Maintenance doses of 20 mg given on days 28, 56, 84, 112 and 140.

Participant Flow:   Overall Study
    Degarelix 80/80 + 40     Degarelix 40/40 + 40     Degarelix 80 + 20  
STARTED     43     46     40  
Randomized     43     46     40  
Intent-to-treat Population     42 [1]   46     39 [1]
Per Protocol Population     38 [2]   44 [3]   38 [4]
COMPLETED     32     30     26  
NOT COMPLETED     11     16     14  
Adverse Event                 0                 5                 3  
Insufficient testosterone response                 5                 8                 10  
Withdrawal by Subject                 1                 0                 0  
Protocol Violation                 1                 0                 1  
Mistakenly withdrawn                 0                 1                 0  
Bad prostate-specific antigen response                 3                 2                 0  
not specified                 1                 0                 0  
[1] One randomised participant withdrew at Day 1.
[2] One participant- baseline testosterone outside normal range. Three participants- prohibited drugs.
[3] Two participants - prohibited drugs
[4] One participant - baseline testosterone outside normal range.



  Baseline Characteristics
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Reporting Groups
  Description
Degarelix 80/80 + 40 Loading doses of Degarelix 80 mg on Days 0 and 3. Maintenance doses of 40 mg given on days 28, 56, 84, 112 and 140.
Degarelix 40/40 + 40 Loading doses of Degarelix 40 mg on Days 0 and 3. Maintenance doses of 40 mg given on days 28, 56, 84, 112 and 140.
Degarelix 80 + 20 Loading dose of Degarelix 80 mg on Day 0. Maintenance doses of 20 mg given on days 28, 56, 84, 112 and 140.
Total Total of all reporting groups

Baseline Measures
    Degarelix 80/80 + 40     Degarelix 40/40 + 40     Degarelix 80 + 20     Total  
Number of Participants  
[units: participants]
 		  43     46     40     129  
Age  
[units: participants]
 		       
<=18 years     0     0     0     0  
Between 18 and 65 years     6     5     7     18  
>=65 years     37     41     33     111  
Age  
[units: years]
Mean ± Standard Deviation 		  72.4  ± 6.6     73.7  ± 7.2     71.8  ± 7.1     72.7  ± 7.0  
Gender  
[units: participants]
 		       
Female     0     0     0     0  
Male     43     46     40     129  
Race/Ethnicity, Customized  
[units: participants]
 		       
White     42     43     37     122  
Black     1     3     1     5  
Oriental / Asian     0     0     0     0  
Afro-carribean     0     0     1     1  
Indian     0     0     1     1  
Region of Enrollment  
[units: participants]
 		       
United Kingdom     43     46     40     129  
Participant Counts by Gleason Score [1]
[units: participants]
 		       
unknown     1     1     1     3  
2-4     3     4     2     9  
5-6     11     7     11     29  
7-10     28     34     26     88  
Stage of Prostate Cancer [2]
[units: participants]
 		       
Localized     8     9     5     22  
Locally advanced     21     21     18     60  
Metastatic     11     14     17     42  
Not classifiable     3     2     0     5  
Body Mass Index [3]
[units: kilogram per square meter]
Median ( Full Range ) 		  26.2  
  ( 18.0 to 36.4 )   		  26.6  
  ( 17.4 to 40.9 )   		  25.2  
  ( 19.8 to 34.1 )   		  26.1  
  ( 17.4 to 40.9 )  
Days Since Diagnosis of Prostate Cancer [4]
[units: days]
Mean ± Standard Deviation 		  52.7  ± 116.0     153.8  ± 518.1     88.8  ± 370.0     99.9  ± 377.2  
Serum Prostate-Specific Antigen level [5]
[units: nanogram/milliliter]
Median ( Full Range ) 		  50.3  
  ( 23.2 to 2580 )   		  64.6  
  ( 18.1 to 2380 )   		  82.9  
  ( 23.7 to 12500 )   		  61.1  
  ( 18.1 to 12500 )  
Serum Testosterone level [6]
[units: nanogram/milliliter]
Median ( Full Range ) 		  3.7  
  ( 2.13 to 7.63 )   		  4.1  
  ( 1.21 to 7.84 )   		  4.8  
  ( 1.58 to 8.94 )   		  4.0  
  ( 1.21 to 8.94 )  
[1] 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.
[2] 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.
[3] Body mass index is a measure of body fat based on height and weight
[4] The number of days passed since a diagnosis of prostate cancer was made for each participant.
[5] 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 positive correlation to prostate cancer.
[6] 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.



  Outcome Measures
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1.  Primary:   Number of Participants With Testosterone <0.5 Nanogram/Milliliter   [ Time Frame: Weeks 1,2,4,8,12,16,20,24 ]
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2.  Secondary:   Number of Participants With Testosterone < 0.5 Nanogram/Milliliter at All Visits Between Weeks 4-24   [ Time Frame: Weeks 4-24 ]
  Show Outcome Measure 2

3.  Secondary:   Number of Participants Not Meeting a Testosterone Withdrawal Criterion Between Weeks 4-24   [ Time Frame: Weeks 4-24 ]
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4.  Secondary:   Number of Participants Who Met the Withdrawl Criteria for Prostate-specific Antigen   [ Time Frame: Six months ]
  Show Outcome Measure 4

5.  Secondary:   Number of Participants With Normal Prostate-specific Antigen Levels During the Study   [ Time Frame: Weeks 12, 24 ]
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6.  Secondary:   The Number of Participants With Abnormal Liver Function Tests   [ Time Frame: Six months ]
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7.  Secondary:   Percentage Change in Vital Signs and Body Weight   [ Time Frame: Baseline and Six months ]
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  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: Clinical Development Support
Organization: Ferring Pharmaceuticals
e-mail: DK0-Disclosure@ferring.com


No publications provided


Responsible Party: Clinical Development Support, Ferring Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00819247     History of Changes
Other Study ID Numbers: FE200486 CS02
Study First Received: January 7, 2009
Results First Received: January 22, 2009
Last Updated: May 18, 2011
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
United Kingdom: Research Ethics Committee