Degarelix as Second-Line Hormonal Treatment After Prostate-specific Antigen (PSA)-Failure in GnRH Agonist Treated Patients With Prostate Cancer

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Ferring Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00738673
First received: August 18, 2008
Last updated: December 12, 2012
Last verified: December 2012
Results First Received: December 12, 2012  
Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Prostate Cancer
Intervention: Drug: degarelix

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Cohort 1 comprised a broad spectrum of biochemically relapsed participants (on castrate level) on long term hormonal treatment in different stages of the disease (primarily advance stages), however not in need of chemotherapy. The second cohort was similar, although testosterone levels were to be above castrate level (≥0.32 ng/mL).

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 - Cohort 1 Participants with baseline testosterone at castrate level. Starting dose: 240 mg by subcutaneous (s.c.) injection in the abdomen on Day 0. Maintenance dose: a maximum of 11 doses of 80 mg degarelix were given 28 days apart via single s.c. injections.
Degarelix - Cohort 2 Participants with baseline testosterone above castrate level (≥0.32 ng/mL ). Starting dose: 240 mg by subcutaneous (s.c.) injection in the abdomen on Day 0. Maintenance dose: a maximum of 11 doses of 80 mg degarelix were given 28 days apart via single s.c. injections.

Participant Flow:   Overall Study
    Degarelix - Cohort 1     Degarelix - Cohort 2  
STARTED     25     12  
Intent to Treat Population     24     12  
COMPLETED     1     1  
NOT COMPLETED     24     11  
Adverse Event                 1                 0  
Lack of Efficacy                 19                 8  
Protocol Violation                 1                 2  
Withdrawal by Subject                 3                 1  



  Baseline Characteristics
  Hide Baseline Characteristics

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.
No text entered.

Reporting Groups
  Description
Degarelix - Cohort 1 Participants with baseline testosterone at castrate level. Starting dose: 240 mg by subcutaneous (s.c.) injection in the abdomen on Day 0. Maintenance dose: a maximum of 11 doses of 80 mg degarelix were given 28 days apart via single s.c. injections.
Degarelix - Cohort 2 Participants with baseline testosterone above castrate level (≥0.32 ng/mL ). Starting dose: 240 mg by subcutaneous (s.c.) injection in the abdomen on Day 0. Maintenance dose: a maximum of 11 doses of 80 mg degarelix were given 28 days apart via single s.c. injections.
Total Total of all reporting groups

Baseline Measures
    Degarelix - Cohort 1     Degarelix - Cohort 2     Total  
Number of Participants  
[units: participants]
  24     12     36  
Age  
[units: years]
Mean ± Standard Deviation
  72.7  ± 9.11     76.5  ± 4.68     73.9  ± 8.08  
Gender  
[units: participants]
     
Female     0     0     0  
Male     24     12     36  
Race/Ethnicity, Customized  
[units: participants]
     
Not Hispanic or Latino     24     12     36  
HIspanic or Latino     0     0     0  
Race/Ethnicity, Customized  
[units: participants]
     
White     24     12     36  
Other     0     0     0  
Weight  
[units: kg]
Mean ± Standard Deviation
  90.5  ± 17.3     87.6  ± 11.0     89.6  ± 15.5  
Height  
[units: meters]
Mean ± Standard Deviation
  1.74  ± 0.06     1.72  ± 0.05     1.73  ± 0.06  
Stage of Prostate Cancer at Diagnosis  
[units: participants]
     
Localized     4     4     8  
Locally advanced     11     1     12  
Metastatic     6     2     8  
Not classifiable     3     5     8  
Stage of Prostate Cancer at Enrolment  
[units: participants]
     
Localized     1     2     3  
Locally advanced     9     0     9  
Metastatic     7     5     12  
Not classifiable     7     5     12  
Gleason Score [1]
[units: participants]
     
2-4     1     3     4  
5-6     4     2     6  
7-10     19     7     26  
Eastern Cooporative Oncology Group (ECOG) Performance Status  
[units: participants]
     
Fully active     0     0     0  
Restricted, but ambulatory     17     11     28  
Ambulatory, unable to work     7     1     8  
Capable of only limited selfcare     0     0     0  
Completely disabled     0     0     0  
[1] The 2005 International Society of Urological Pathologists recommendations for Gleason scoring were used to grade tumors. A primary grade is assigned to the most common tumor pattern (how the cancer cells look under a microscope), and a second grade to the next most common pattern. The two grades are added together to get a Gleason Score with a range of 2-10; 10=worst prognosis.



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Participants’ Response in Prostate-Specific Antigen (PSA) Level at Three Months As Compared to Baseline   [ Time Frame: Day 0 (baseline), 3 months ]

2.  Secondary:   Participants’ Response in Prostate-Specific Antigen (PSA) Level at One Month As Compared to Baseline   [ Time Frame: Day 0 (baseline), 1 month ]

3.  Secondary:   Participants' Response in Prostate-Specific Antigen (PSA) Level at Two Months As Compared to Baseline   [ Time Frame: Day 0 (baseline), 2 months ]

4.  Secondary:   Participants at Testosterone Castrate Level Throughout the Study   [ Time Frame: up to month 12 ]

5.  Secondary:   Change From Baseline in Serum Levels of Testosterone at the Last Visit   [ Time Frame: Day 0 (baseline), up to month 12 (last visit) ]

6.  Secondary:   Change From Baseline in Serum Levels of Prostate-Specific Antigen (PSA) at Last Visit   [ Time Frame: Day 0 (baseline), up to month 12 (last visit) ]

7.  Secondary:   Percent Change From Baseline in Serum Levels of Luteinising Hormone (LH) at the Last Visit   [ Time Frame: Day 0 (baseline), up to month 12 (last visit) ]

8.  Secondary:   Change From Baseline in Serum Levels of Follicle-Stimulating Hormone (FSH) at the Last Visit   [ Time Frame: Day 0 (baseline), up to month 12 (last visit) ]

9.  Secondary:   Participants at Testosterone Level <=0.2 ng/mL Throughout the Study   [ Time Frame: up to month 12 ]

10.  Secondary:   Participants at Testosterone Level <=0.32 ng/mL Throughout the Study   [ Time Frame: up to month 12 ]

11.  Secondary:   Participants With Prostate-Specific Antigen (PSA) Progression Throughout the Study   [ Time Frame: up to month 12 ]

12.  Secondary:   Kaplan-Meier Estimate for Overall Survival   [ Time Frame: up to month 12 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide 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.


  More Information
  Hide More Information

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: NCT00738673     History of Changes
Other Study ID Numbers: FE200486 CS27, 2008-000585-22
Study First Received: August 18, 2008
Results First Received: December 12, 2012
Last Updated: December 12, 2012
Health Authority: Germany: Federal Institute for Drugs and Medical Devices