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Neoadjuvant Study Investigating Degarelix in Patients Suffering From Prostate Cancer

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Ferring Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00833248
First received: January 30, 2009
Last updated: September 27, 2012
Last verified: September 2012
History of Changes
Results First Received: August 27, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Prostate Cancer
Interventions: Drug: Degarelix
Drug: Goserelin
Drug: Bicalutamide

  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
The participants were recruited by outpatient urologists, radiotherapists or oncologists. A total of 240 patients were to be randomised in a 3:1 ratio to one of two treatment groups (180 participants were to be treated with degarelix; 60 participants were to be treated with goserelin+bicalutamide). The recruitment period was April 2009 - June 2011.

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/80 mg The degarelix doses were administered into the abdominal wall every 28 days. A starting dose of 240 mg (40 mg/mL) degarelix was administered on Day 0 as two 3 mL subcutaneous (s.c.) injections. The second and third doses of 80 mg (20 mg/mL) degarelix were administered as single 4 mL s.c. injections on Days 28 and 56, respectively.
Goserelin (3.6 mg) + Bicalutamide (50 mg)

On Day 0, the participants began once-daily oral (p.o.) treatment with bicalutamide as anti-androgen flare protection. This treatment continued for 2 weeks after the first dose of goserelin (i.e. 17 days in total).

On Day 3, the first goserelin implant was inserted s.c. into the abdominal wall. The second and third doses of goserelin were administered on Days 31 and 59, respectively.

Participant Flow:   Overall Study
    Degarelix 240 mg/80 mg     Goserelin (3.6 mg) + Bicalutamide (50 mg)  
STARTED     181     65  
Full Analysis Set (FAS)     180     64  
Per Protocol (PP) Analysis Set     164     57  
Safety Analysis Set     181     64  
COMPLETED     177     62  
NOT COMPLETED     4     3  
Adverse Event                 3                 0  
Protocol Violation                 1                 2  
Withdrawal by Subject                 0                 1  



  Baseline Characteristics
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Reporting Groups
  Description
Degarelix 240 mg/80 mg The degarelix doses were administered into the abdominal wall every 28 days. A starting dose of 240 mg (40 mg/mL) degarelix was administered on Day 0 as two 3 mL subcutaneous (s.c.) injections. The second and third doses of 80 mg (20 mg/mL) degarelix were administered as single 4 mL s.c. injections on Days 28 and 56, respectively.
Goserelin (3.6 mg) + Bicalutamide (50 mg)

On Day 0, the participants began once-daily oral (p.o.) treatment with bicalutamide as anti-androgen flare protection. This treatment continued for 2 weeks after the first dose of goserelin (i.e. 17 days in total).

On Day 3, the first goserelin implant was inserted s.c. into the abdominal wall. The second and third doses of goserelin were administered on Days 31 and 59, respectively.
Total Total of all reporting groups

Baseline Measures
    Degarelix 240 mg/80 mg     Goserelin (3.6 mg) + Bicalutamide (50 mg)     Total  
Number of Participants  
[units: participants]
 		  180     64     244  
Age [1]
[units: years]
Mean ± Standard Deviation 		  70.6  ± 6.37     70.8  ± 5.96     70.6  ± 6.25  
Gender [2]
[units: participants]
 		     
Female     0     0     0  
Male     180     64     244  
Race (NIH/OMB) [2]
[units: participants]
 		     
American Indian or Alaska Native     1     0     1  
Asian     1     0     1  
Native Hawaiian or Other Pacific Islander     0     0     0  
Black or African American     15     3     18  
White     163     61     224  
More than one race     0     0     0  
Unknown or Not Reported     0     0     0  
Region of Enrollment [2]
[units: participants]
 		     
United States     45     16     61  
France     60     22     82  
Greece     5     2     7  
Spain     9     3     12  
Netherlands     11     2     13  
Germany     9     4     13  
United Kingdom     41     15     56  
Body Weight [2]
[units: kilogram]
Mean ± Standard Deviation 		  83.6  ± 14.2     80.9  ± 12.4     82.9  ± 13.8  
Body Mass Index [2]
[units: kilogram per square meter]
Mean ± Standard Deviation 		  27.8  ± 3.99     26.8  ± 3.69     27.5  ± 3.93  
Gleason Score [3]
[units: participants]
 		     
Gleason Score 2-6     41     12     53  
Gleason Score 7     97     42     139  
Gleason Score 8-10     42     10     52  
Stage of Prostate Cancer [4]
[units: participants]
 		     
Localized     111     41     152  
Locally Advanced     63     20     83  
Metastatic     0     0     0  
Not Classifiable     6     3     9  
Serum Testosterone Levels [2]
[units: nanograms per milliliter]
Median ( Full Range ) 		  3.92  
  ( 0.557 to 11.2 )   		  4.42  
  ( 0.188 to 8.16 )   		  4.06  
  ( 0.188 to 11.2 )  
Serum Prostate-Specific Antigen (PSA) Levels [2]
[units: nanograms per millilter]
Median ( Full Range ) 		  10  
  ( 2.5 to 339 )   		  9.75  
  ( 2.9 to 80 )   		  9.95  
  ( 2.5 to 339 )  
Serum Oestradiol Levels [2]
[units: nanograms per deciliter]
Median ( Full Range ) 		  1.9  
  ( 0.74 to 4.4 )   		  1.9  
  ( 1 to 3.6 )   		  1.9  
  ( 0.74 to 4.4 )  
Prostate Volume [5]
[units: milliliter]
Mean ± Standard Deviation 		  50.9  ± 20.3     52.5  ± 18.8     51.3  ± 19.9  
Total International Prostate Symptom Score (IPSS) [6]
[units: scores on a scale]
Mean ± Standard Deviation 		  9.5  ± 6.71     8.46  ± 6.3     9.23  ± 6.61  
Quality of Life (QoL) Related to Urinary Symptoms [7]
[units: scores on a scale]
Mean ± Standard Deviation 		  2.27  ± 1.63     1.94  ± 1.56     2.19  ± 1.62  
[1] Full analysis set (FAS).
[2] FAS.
[3] FAS. 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.
[4] FAS. Prostate cancer stage was classified according to the Tumor, Nodes, and Metastatic (TNM) scale 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. Some participants did not have their prostate cancer classified for the complete TNM scale (9 participants).
[5] FAS. Prostate volume was measured with a Trans Rectal Ultrasound Scan (TRUS).
[6] FAS. The IPSS is a tool commonly used to assess the severity of lower urinary tract symptoms (LUTS), and to monitor the progress of the disease once treatment has been initiated. The participant completes a questionnaire containing 7 questions regarding incomplete emptying, frequency, intermittency, urgency, weak stream, straining, and nocturia. Each question is assigned a score of 0-5. The total score is then classified according to the following scale: 0 to 7 = mildly symptomatic; 8 to 19 = moderately symptomatic; and 20 to 35 = severely symptomatic.
[7] FAS. The IPSS questionnaire included an additional single question to assess the participant's QoL in relation to his urinary symptoms. The question was: 'If you were to spend the rest of your life with your urinary condition the way it is now, how would you feel about that?' The possible answers to this question ranged from 'delighted' (a score of '0') to 'terrible' (a score of '6').



  Outcome Measures
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1.  Primary:   Change From Baseline in Prostate Size Based on Trans Rectal Ultra Sound (TRUS) at Week 12 (Full Analysis Set)   [ Time Frame: After treatment of 12 weeks compared to Baseline ]
  Show Outcome Measure 1

2.  Primary:   Change From Baseline in Prostate Size Based on Trans Rectal Ultra Sound (TRUS) at Week 12 (Per Protocol Analysis Set)   [ Time Frame: After treatment of 12 weeks compared to Baseline ]
  Show Outcome Measure 2

3.  Secondary:   Change From Baseline in Total International Prostate Symptom Score (IPSS) at Week 4, 8, and 12   [ Time Frame: After treatment of 4, 8, and 12 weeks compared to Baseline ]
  Show Outcome Measure 3

4.  Secondary:   Change From Baseline in Serum Testosterone Levels During the Study   [ Time Frame: After treatment of 4, 8, and 12 weeks compared to Baseline ]
  Show Outcome Measure 4

5.  Secondary:   Change From Baseline in Serum Prostate-Specific Antigen (PSA) Levels During the Study   [ Time Frame: After treatment of 4, 8, and 12 weeks compared to Baseline ]
  Show Outcome Measure 5

6.  Secondary:   Change From Baseline in Serum Oestradiol Levels During the Study   [ Time Frame: After treatment of 4, 8, and 12 weeks compared to Baseline ]
  Show Outcome Measure 6

7.  Secondary:   Change From Baseline in Quality of Life (QoL) Related to Urinary Symptoms at Each Visit   [ Time Frame: After treatment of 4, 8, and 12 weeks compared to Baseline ]
  Show Outcome Measure 7

8.  Secondary:   Number of Participants With Markedly Abnormal Values in Vital Signs and Body Weight   [ Time Frame: Baseline to 12 weeks of treatment ]
  Show Outcome Measure 8

9.  Secondary:   Number of Participants With Markedly Abnormal Values in Safety Laboratory Variables   [ Time Frame: Baseline to 12 weeks of treatment ]
  Show Outcome Measure 9


  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


No publications provided by Ferring Pharmaceuticals

Publications automatically indexed to this study:


Responsible Party: Ferring Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00833248     History of Changes
Other Study ID Numbers: FE200486 CS30, 2008-005232-33
Study First Received: January 30, 2009
Results First Received: August 27, 2012
Last Updated: September 27, 2012
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
Germany: Federal Institute for Drugs and Medical Devices
Spain: Spanish Agency of Medicines
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Greece: National Organization of Medicines
Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
United States: Food and Drug Administration