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Dose Finding Trial With a New Treatment (Degarelix) for Prostate Cancer

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Ferring Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00819156
First received: January 7, 2009
Last updated: December 20, 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
Two hundred and sixteen patients were screened. Twenty-seven were screening failures. Two randomized patients were not treated: one withdrew consent and the other had an elevated alanine aminotransferase value (an exclusion criteria found after randomization).

Reporting Groups
  Description
Degarelix 200/80 Cycle 1 was an initial 200 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 80 milligrams each of Degarelix. Each cycle was 28 days.
Degarelix 200/120 Cycle 1 was an initial 200 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 120 milligrams each of Degarelix. Each cycle was 28 days.
Degarelix 200/160 Cycle 1 was an initial 200 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 160 milligrams each of Degarelix. Each cycle was 28 days.
Degarelix 240/80 Cycle 1 was an initial 240 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 80 milligrams each of Degarelix. Each cycle was 28 days.
Degarelix 240/120 Cycle 1 was an initial 240 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 120 milligrams each of Degarelix. Each cycle was 28 days.
Degarelix 240/160 Cycle 1 was an initial 240 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 160 milligrams each of Degarelix. Each cycle was 28 days.

Participant Flow:   Overall Study
    Degarelix 200/80     Degarelix 200/120     Degarelix 200/160     Degarelix 240/80     Degarelix 240/120     Degarelix 240/160  
STARTED     30     33     32     30     33     31  
Randomised and Treated (ITT Population)     30     32     32     30     33     30  
COMPLETED     20     23     26     28     27     23  
NOT COMPLETED     10     10     6     2     6     8  
Adverse Event                 1                 4                 2                 1                 2                 3  
Withdrawal by Subject                 0                 3                 2                 0                 1                 0  
Protocol Violation                 1                 0                 1                 0                 0                 1  
Lost to Follow-up                 0                 1                 0                 0                 0                 2  
Testosterone >1ng/ml from Day 28+                 5                 2                 1                 1                 1                 2  
Testosterone >=.5ng/ml 2 visits                 3                 0                 0                 0                 1                 0  
Prostate-specific antigen progression                 0                 0                 0                 0                 1                 0  



  Baseline Characteristics
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Reporting Groups
  Description
Degarelix 200/80 Cycle 1 was an initial 200 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 80 milligrams each of Degarelix. Each cycle was 28 days.
Degarelix 200/120 Cycle 1 was an initial 200 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 120 milligrams each of Degarelix. Each cycle was 28 days.
Degarelix 200/160 Cycle 1 was an initial 200 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 160 milligrams each of Degarelix. Each cycle was 28 days.
Degarelix 240/80 Cycle 1 was an initial 240 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 80 milligrams each of Degarelix. Each cycle was 28 days.
Degarelix 240/120 Cycle 1 was an initial 240 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 120 milligrams each of Degarelix. Each cycle was 28 days.
Degarelix 240/160 Cycle 1 was an initial 240 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 160 milligrams each of Degarelix. Each cycle was 28 days.
Total Total of all reporting groups

Baseline Measures
    Degarelix 200/80     Degarelix 200/120     Degarelix 200/160     Degarelix 240/80     Degarelix 240/120     Degarelix 240/160     Total  
Number of Participants  
[units: participants]
 		  30     32     32     30     33     30     187  
Age  
[units: participants]
 		             
<=18 years     0     0     0     0     0     0     0  
Between 18 and 65 years     7     5     5     6     7     7     37  
>=65 years     23     27     27     24     26     23     150  
Age  
[units: years]
Mean ± Standard Deviation 		  69.9  ± 8.27     70.6  ± 7.72     73.3  ± 7.39     70.4  ± 7.07     70.7  ± 7.56     70.7  ± 8.59     70.9  ± 7.75  
Gender  
[units: participants]
 		             
Female     0     0     0     0     0     0     0  
Male     30     32     32     30     33     30     187  
Race (NIH/OMB)  
[units: participants]
 		             
American Indian or Alaska Native     0     0     0     0     0     0     0  
Asian     0     0     0     0     1     0     1  
Native Hawaiian or Other Pacific Islander     0     0     0     0     0     0     0  
Black or African American     1     2     1     0     2     0     6  
White     29     30     31     30     30     30     180  
More than one race     0     0     0     0     0     0     0  
Unknown or Not Reported     0     0     0     0     0     0     0  
Number of Patients at Each Stage of Prostate Cancer [1]
[units: patients]
 		             
Localized     8     6     6     5     11     5     41  
Locally advanced     8     11     11     12     8     10     60  
Metastatic     4     8     5     5     7     7     36  
Not classifiable     10     7     10     8     7     8     50  
Patient Counts by Gleason Score [2]
[units: participants]
 		             
unknown     0     0     2     0     0     0     2  
2-4     4     10     6     9     4     3     36  
5-6     13     10     14     10     17     12     76  
7-10     13     12     10     11     12     15     73  
Body Mass Index [3]
[units: kilograms per square meter]
Mean ± Standard Deviation 		  26.4  ± 3.5     26.4  ± 3.74     25.9  ± 4.46     27.7  ± 5.3     26  ± 3.28     25.3  ± 2.73     26.3  ± 3.94  
Days Since Diagnosis of Prostate Cancer [4]
[units: days]
Mean ± Standard Deviation 		  493  ± 849     122  ± 230     375  ± 1098     383  ± 817     229  ± 508     352  ± 743     323  ± 756  
Median Serum Testosterone Level [5]
[units: nanogram / milliliter]
Median ( Full Range ) 		  4.47  
  ( 0.816 to 7.1 )   		  3.93  
  ( 1.53 to 9.29 )   		  4.79  
  ( 2.8 to 9.47 )   		  4.28  
  ( 1.4 to 10.2 )   		  4.07  
  ( 2.02 to 7.7 )   		  3.88  
  ( 1.69 to 8.63 )   		  4.13  
  ( 0.816 to 10.2 )  
Serum Prostate-specific Antigen [6]
[units: nanogram / milliliter]
Median ( Full Range ) 		  15.2  
  ( 2.6 to 332 )   		  31.5  
  ( 3.3 to 1730 )   		  31.5  
  ( 2.6 to 901 )   		  23.1  
  ( 3.6 to 586 )   		  35.3  
  ( 2.4 to 1110 )   		  32  
  ( 2 to 1297 )   		  27.6  
  ( 2 to 1730 )  
[1] 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 tummors that may involve the lymph nodes but no metastasis. Metastatic are more advanced cancers that are spreading beyond the original tumor.
[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] Body mass index is a measure of body fat based on height and weight.
[4] The mean number of days that have passed since a diagnosis of prostate cancer was made for each patient.
[5] 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.
[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 positive correlation to prostate cancer.



  Outcome Measures
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1.  Primary:   Number of Patients With Testosterone <=0.5 Nanograms/Milliliter From Day 28 to Day 364   [ Time Frame: 12 months ]
  Show Outcome Measure 1

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

3.  Secondary:   Number of Patients With Testosterone <=0.5 Nanogram/Milliliter at Day 28.   [ Time Frame: Day 28 ]
  Show Outcome Measure 3

4.  Secondary:   Number of Patients With Testoterone <=0.5 Nanogram/Milliliter at Day 3.   [ Time Frame: Day 3 ]
  Show Outcome Measure 4

5.  Secondary:   Days to 50 Percent Reduction in Prostate-Specific Antigen   [ Time Frame: Day 0 (post dose) to Day 364 ]
  Show Outcome Measure 5

6.  Secondary:   Days to 90 Percent Reduction in Prostate-Specific Antigen   [ Time Frame: Day 0 (post dose) to Day 364 ]
  Show Outcome Measure 6

7.  Secondary:   Days to Prostate-Specific Antigen Progression   [ Time Frame: Day 0 (post dose) to Day 364 ]
  Show Outcome Measure 7

8.  Secondary:   Median Serum Testosterone Levels   [ Time Frame: Day 0 (Baseline), Days 1,3,7,14, and 364 ]
  Show Outcome Measure 8

9.  Secondary:   Median Prostate-specific Antigen Levels   [ Time Frame: Day 0 (Baseline), Days 3, 7, 14, and 364 ]
  Hide Outcome Measure 9

Measure Type Secondary
Measure Title Median Prostate-specific Antigen Levels
Measure Description No text entered.
Time Frame Day 0 (Baseline), Days 3, 7, 14, and 364  
Safety Issue No  

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.
ITT population

Reporting Groups
  Description
Degarelix 200/80 Cycle 1 was an initial 200 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 80 milligrams each of Degarelix. Each cycle was 28 days.
Degarelix 200/120 Cycle 1 was an initial 200 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 120 milligrams each of Degarelix. Each cycle was 28 days.
Degarelix 200/160 Cycle 1 was an initial 200 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 160 milligrams each of Degarelix. Each cycle was 28 days.
Degarelix 240/80 Cycle 1 was an initial 240 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 80 milligrams each of Degarelix. Each cycle was 28 days.
Degarelix 240/120 Cycle 1 was an initial 240 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 120 milligrams each of Degarelix. Each cycle was 28 days.
Degarelix 240/160 Cycle 1 was an initial 240 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 160 milligrams each of Degarelix. Each cycle was 28 days.

Measured Values
    Degarelix 200/80     Degarelix 200/120     Degarelix 200/160     Degarelix 240/80     Degarelix 240/120     Degarelix 240/160  
Number of Participants Analyzed  
[units: participants]
 		  30     32     32     30     33     30  
Median Prostate-specific Antigen Levels  
[units: nanogram / milliliter]
Median ( Full Range ) 		           
Day 0 (Baseline)     15.2  
  ( 2.6 to 332 )   		  31.5  
  ( 3.3 to 1730 )   		  31.5  
  ( 2.6 to 901 )   		  23.1  
  ( 3.6 to 586 )   		  35.3  
  ( 2.4 to 1110 )   		  32  
  ( 2 to 1297 )  
Day 3 (n=29,30,28,29,33,28)     13.7  
  ( 2.4 to 207 )   		  29.9  
  ( 3 to 1061 )   		  27.8  
  ( 2 to 443 )   		  22.2  
  ( 2.7 to 503 )   		  26.3  
  ( 1.8 to 928 )   		  25.2  
  ( 1.3 to 945 )  
Day 7 (n=30,32,32,30,33,28)     10.6  
  ( 1.9 to 138 )   		  18.5  
  ( 2.4 to 420 )   		  16.5  
  ( 1.8 to 234 )   		  14.8  
  ( 2.4 to 339 )   		  20.8  
  ( 1.5 to 611 )   		  16.9  
  ( 0.9 to 476 )  
Day 14 (n=29,31,32,29,33,28)     7.9  
  ( 1 to 69.5 )   		  10.9  
  ( 1.8 to 155 )   		  9.9  
  ( 1.3 to 142 )   		  7.1  
  ( 1.4 to 213 )   		  13.4  
  ( 0.4 to 490 )   		  8.35  
  ( 0.4 to 163 )  
Day 364 (n=20,23,26,28,27,22)     0.45  
  ( 0.1 to 5.5 )   		  0.6  
  ( 0.1 to 21.2 )   		  0.95  
  ( 0.1 to 21.6 )   		  0.9  
  ( 0.1 to 135 )   		  0.8  
  ( 0.1 to 48.6 )   		  0.3  
  ( 0.1 to 9.4 )  

No statistical analysis provided for Median Prostate-specific Antigen Levels



10.  Secondary:   Median Values of Di-Hydrotestosterone   [ Time Frame: Day 0 (Baseline), Days 1, 3, 7, 14, and 364 ]
  Show Outcome Measure 10

11.  Secondary:   Median Values for Serum Luteinizing Hormone   [ Time Frame: Day 0 (Baseline), Days 1, 3, 7, 14, and 364 ]
  Show Outcome Measure 11

12.  Secondary:   Median Values for Follicle Stimulation Hormone   [ Time Frame: Day 0 (Baseline), Days 1, 3, 7, 14, and 364 ]
  Show Outcome Measure 12

13.  Secondary:   The Number of Patients With Abnormal Liver Function Tests   [ Time Frame: 364 days ]
  Show Outcome Measure 13

14.  Secondary:   The Number of Patients With Markedly Abnormal Changes in Vital Signs or Body Weight   [ Time Frame: Day 364 ]
  Show Outcome Measure 14


  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


Publications of Results:


Responsible Party: Ferring Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00819156     History of Changes
Other Study ID Numbers: FE200486 CS12
Study First Received: January 7, 2009
Results First Received: January 22, 2009
Last Updated: December 20, 2011
Health Authority: Russia: FSI Scientific Center of Expertise of Medical Application
Russia: Ministry of Health of the Russian Federation
Russia: Ethics Committee
Romania: Ministry of Public Health
Romania: National Medicines Agency
Hungary: National Institute of Pharmacy
Netherlands: Ministry of Health, Welfare and Sport
Netherlands: Independent Ethics Committee
Belgium: Federal Agency for Medicinal Products and Health Products
Belgium: Institutional Review Board
Germany: Federal Institute for Drugs and Medical Devices
Germany: Ethics Commission
Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Poland: Ministry of Health
South Africa: Department of Health
South Africa: Human Research Ethics Committee