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A Trial of Degarelix in Patients With Prostate Cancer

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Ferring Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00946920
First received: July 3, 2009
Last updated: May 2, 2014
Last verified: May 2014
History of Changes
Results First Received: February 14, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Prostate Cancer
Interventions: Drug: Degarelix
Drug: Goserelin acetate

  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
Subjects who met the eligibility criteria were randomized to degarelix or goserelin acetate treatment in a 2:1-ratio. 859 subjects were randomized but 11 subjects did not receive any treatment.

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/480 mg Degarelix: The degarelix doses were administered by subcutaneous (s.c.) injections into the abdominal wall. A starting dose of 240 mg degarelix was administered on Day 0. One month later a maintenance dose of 480 mg was administered. This was repeated after 4, 7, and 10 months (ie a total of 5 administrations).
Goserelin Acetate Goserelin acetate: The goserelin doses were administered by subcutaneous (s.c.) implants into the abdominal wall. An initial dose of 3.6 mg goserelin was administered on Day 0. One month later a subsequent dose of 10.8 mg was administered and this was repeated after 4, 7, and 10 months (ie a total of 5 implants).

Participant Flow:   Overall Study
    Degarelix 240 mg/480 mg   Goserelin Acetate
STARTED   565 [1]   283 [2] 
Full Analysis Set (FAS)   565 [3]   282 [4] 
COMPLETED   455   239 
NOT COMPLETED   110   44 
Withdrawal by Subject                28                15 
Lost to Follow-up                2                2 
Physician Decision                5                2 
Adverse Event                41                14 
Protocol Violation                16                8 
Miscellaneous reasons                18                3 
[1] Received at least one dose of degarelix.
[2] Received at least one dose of goserelin acetate.
[3] Received at least one dose of degarelix and had at least one post-dosing efficacy assessment.
[4] Received at least one dose of goserelin and had at least one post-dosing efficacy assessment.



  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.
FAS

Reporting Groups
  Description
Degarelix 240 mg/480 mg Degarelix: The degarelix doses were administered by subcutaneous (s.c.) injections into the abdominal wall. A starting dose of 240 mg degarelix was administered on Day 0. One month later a maintenance dose of 480 mg was administered. This was repeated after 4, 7, and 10 months (ie a total of 5 administrations).
Goserelin Acetate Goserelin acetate: The goserelin doses were administered by subcutaneous (s.c.) implants into the abdominal wall. An initial dose of 3.6 mg goserelin was administered on Day 0. One month later a subsequent dose of 10.8 mg was administered and this was repeated after 4, 7, and 10 months (ie a total of 5 implants).
Total Total of all reporting groups

Baseline Measures
   Degarelix 240 mg/480 mg   Goserelin Acetate   Total 
Overall Participants Analyzed 
[Units: Participants]
 		 565   282   847 
Age 
[Units: Years]
Mean (Standard Deviation) 		 71.9  (8.3)   71.1  (7.9)   71.6  (8.2) 
Gender 
[Units: Participants]
 		     
Female   0   0   0 
Male   565   282   847 
Race (NIH/OMB) 
[Units: Participants]
 		     
American Indian or Alaska Native   45   25   70 
Asian   4   1   5 
Native Hawaiian or Other Pacific Islander   0   1   1 
Black or African American   41   16   57 
White   475   239   714 
More than one race   0   0   0 
Unknown or Not Reported   0   0   0 
Median Baseline Serum Testosterone Levels (ng/mL) 
[Units: ng/mL]
Median (Full Range) 		 4.52 
 (0.56 to 14.5)  		 4.62 
 (0.07 to 13.2)  		 4.54 
 (0.07 to 14.5) 
Median Baseline Serum Prostate-specific Antigen Levels (ng/mL) 
[Units: ng/mL]
Median (Full Range) 		 19.0 
 (0.26 to 8762)  		 19.1 
 (0.01 to 12961)  		 19.0 
 (0.01 to 12961) 
Baseline Short Form-36 (SF-36) Total Scores [1] 
[Units: Units on a scale]
Mean (Standard Deviation) 		 49.7  (11.5)   50.2  (11.4)   49.9  (11.4) 
[1] The SF-36 is a multi-purpose, short-form health survey with only 36 questions and with a minimum score of 0 and a maximum score of 100. The higher score the better health. It yields an 8-scale profile of functional health and well-being scores as well as psychometrically-based physical and mental health summary measures and a preference-based health utility index. The SF-36 has proven useful in surveys of general and specific populations, comparing the relative burden of diseases, and in differentiating the health benefits produced by a wide range of different treatments.
Baseline Total International Prostate Symptom Scores (IPSS) [1] 
[Units: Units on a scale]
Mean (Standard Deviation) 		 11.8  (7.93)   11.6  (8.02)   11.7  (7.96) 
[1] IPSS is used to assess severity of lower urinary tract symptoms and to monitor the progress of symptoms once treatment has been initiated. It contains 7 questions regarding incomplete emptying, frequency, intermittency, urgency, weak stream, straining, and nocturia. Each question is assigned a score of 0-5 (i.e. the minimum total score is 0 and the maximum is 35). A score of “0” corresponds to a response of “not at all” for the first six symptoms and “none” for nocturia, and a score of 5 corresponds to a response of “almost always” for the first six symptoms and “5 times or more” for nocturia.


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Cumulative Probability of Testosterone at Castrate Level (≤0.5 ng/mL) With Degarelix   [ Time Frame: From Day 28 to Day 364 ]
  Show Outcome Measure 1

2.  Primary:   Difference in Cumulative Probability of Testosterone at Castrate Level (≤0.5 ng/mL) Between Degarelix and Goserelin   [ Time Frame: Day 3 to Day 364 ]
  Show Outcome Measure 2

3.  Secondary:   Serum Levels of Testosterone Over Time   [ Time Frame: Baseline and after 1, 2, 3, 6 and 13 months ]
  Show Outcome Measure 3

4.  Secondary:   Percent Change in Serum Levels of Prostate-specific Antigen (PSA) Over Time   [ Time Frame: Baseline and after 1, 2, 3, 6 and 13 months ]
  Show Outcome Measure 4

5.  Secondary:   Change in Health-related Quality of Life (HRQoL), as Measured by Short Form-36 (SF-36) Score at Month 10 and Month 13 Compared to Baseline   [ Time Frame: At baseline, 10 months and 13 months ]
  Show Outcome Measure 5

6.  Secondary:   Change in International Prostate Symptom Score (IPSS) Score at Months 1, 4, 7, and 13 Compared to Baseline   [ Time Frame: At baseline, 1 month, 4 months, 7 months and 13 months ]
  Show Outcome Measure 6


  Serious Adverse Events
  Hide Serious Adverse Events

Time Frame Adverse events were recorded from signed informed consent until the end-of-trial visit, Day 364 (Month 13).
Additional Description Adverse events were evaluated at each visit.

Reporting Groups
  Description
Degarelix 240 mg/480 mg Degarelix: The degarelix doses were administered by subcutaneous (s.c.) injections into the abdominal wall. A starting dose of 240 mg degarelix was administered on Day 0. One month later a maintenance dose of 480 mg was administered. This was repeated after 4, 7, and 10 months (ie a total of 5 administrations).
Goserelin Acetate Goserelin acetate: The goserelin doses were administered by subcutaneous (s.c.) implants into the abdominal wall. An initial dose of 3.6 mg goserelin was administered on Day 0. One month later a subsequent dose of 10.8 mg was administered and this was repeated after 4, 7, and 10 months (ie a total of 5 implants).

Serious Adverse Events
    Degarelix 240 mg/480 mg   Goserelin Acetate
Total, Serious Adverse Events     
# participants affected / at risk   58/565 (10.27%)   33/283 (11.66%) 
Blood and lymphatic system disorders     
Anaemia † 1     
# participants affected / at risk   2/565 (0.35%)   2/283 (0.71%) 
Haemorrhagic anaemia † 1     
# participants affected / at risk   1/565 (0.18%)   0/283 (0.00%) 
Cardiac disorders     
Angina pectoris † 1     
# participants affected / at risk   2/565 (0.35%)   0/283 (0.00%) 
Cardiac failure acute † 1     
# participants affected / at risk   2/565 (0.35%)   0/283 (0.00%) 
Coronary artery disease † 1     
# participants affected / at risk   2/565 (0.35%)   0/283 (0.00%) 
Supraventricular tachycardia † 1     
# participants affected / at risk   0/565 (0.00%)   2/283 (0.71%) 
Acute myocardial infarction † 1     
# participants affected / at risk   1/565 (0.18%)   1/283 (0.35%) 
Angina unstable † 1     
# participants affected / at risk   0/565 (0.00%)   1/283 (0.35%) 
Atrial fibrillation † 1     
# participants affected / at risk   1/565 (0.18%)   1/283 (0.35%) 
Cardiac arrest † 1     
# participants affected / at risk   1/565 (0.18%)   0/283 (0.00%) 
Cardiopulmonary failure † 1     
# participants affected / at risk   1/565 (0.18%)   0/283 (0.00%) 
Myocardial infarction † 1     
# participants affected / at risk   1/565 (0.18%)   1/283 (0.35%) 
Congenital, familial and genetic disorders     
Phimosis † 1     
# participants affected / at risk   0/565 (0.00%)   1/283 (0.35%) 
Eye disorders     
Cataract † 1     
# participants affected / at risk   1/565 (0.18%)   0/283 (0.00%) 
Eye pain † 1     
# participants affected / at risk   0/565 (0.00%)   1/283 (0.35%) 
Gastrointestinal disorders     
Gastrointestinal haemorrhage † 1     
# participants affected / at risk   2/565 (0.35%)   0/283 (0.00%) 
Inguinal hernia † 1     
# participants affected / at risk   2/565 (0.35%)   1/283 (0.35%) 
Intestinal obstruction † 1     
# participants affected / at risk   2/565 (0.35%)   0/283 (0.00%) 
Abdominal hernia † 1     
# participants affected / at risk   1/565 (0.18%)   0/283 (0.00%) 
Dyspepsia † 1     
# participants affected / at risk   0/565 (0.00%)   1/283 (0.35%) 
Enterocolitis haemorrhagic † 1     
# participants affected / at risk   0/565 (0.00%)   1/283 (0.35%) 
Gastric ulcer haemorrhage † 1     
# participants affected / at risk   1/565 (0.18%)   0/283 (0.00%) 
Pancreatitis † 1     
# participants affected / at risk   1/565 (0.18%)   0/283 (0.00%) 
Pancreatitis acute † 1     
# participants affected / at risk   0/565 (0.00%)   1/283 (0.35%) 
Rectal haemorrhage † 1     
# participants affected / at risk   0/565 (0.00%)   1/283 (0.35%) 
General disorders     
Death † 1     
# participants affected / at risk   0/565 (0.00%)   1/283 (0.35%) 
Non-cardiac chest pain † 1     
# participants affected / at risk   1/565 (0.18%)   0/283 (0.00%) 
Oedema peripheral † 1     
# participants affected / at risk   1/565 (0.18%)   0/283 (0.00%) 
Pyrexia † 1     
# participants affected / at risk   0/565 (0.00%)   1/283 (0.35%) 
Sudden cardiac death † 1     
# participants affected / at risk   0/565 (0.00%)   1/283 (0.35%) 
Sudden death † 1     
# participants affected / at risk   1/565 (0.18%)   0/283 (0.00%) 
Hepatobiliary disorders     
Cholecystitis † 1     
# participants affected / at risk   1/565 (0.18%)   0/283 (0.00%) 
Infections and infestations     
Lobar pneumonia † 1     
# participants affected / at risk   1/565 (0.18%)   2/283 (0.71%) 
Pneumonia † 1     
# participants affected / at risk   0/565 (0.00%)   2/283 (0.71%) 
Cellulitis † 1     
# participants affected / at risk   1/565 (0.18%)   0/283 (0.00%) 
Gastroenteritis † 1     
# participants affected / at risk   1/565 (0.18%)   0/283 (0.00%) 
Infective exacerbation of chronic obstructive airways † 1     
# participants affected / at risk   1/565 (0.18%)   0/283 (0.00%) 
Injection site abscess † 1     
# participants affected / at risk   1/565 (0.18%)   0/283 (0.00%) 
Lung abscess † 1     
# participants affected / at risk   0/565 (0.00%)   1/283 (0.35%) 
Pyelonephritis acute † 1     
# participants affected / at risk   1/565 (0.18%)   0/283 (0.00%) 
Pyothorax † 1     
# participants affected / at risk   1/565 (0.18%)   0/283 (0.00%) 
Sepsis † 1     
# participants affected / at risk   1/565 (0.18%)   1/283 (0.35%) 
Staphylococcal bacteraemia † 1     
# participants affected / at risk   1/565 (0.18%)   0/283 (0.00%) 
Staphylococcal infection † 1     
# participants affected / at risk   1/565 (0.18%)   0/283 (0.00%) 
Urinary tract infection † 1     
# participants affected / at risk   1/565 (0.18%)   0/283 (0.00%) 
Injury, poisoning and procedural complications     
Coronary artery reocclusion † 1     
# participants affected / at risk   0/565 (0.00%)   1/283 (0.35%) 
Dislocation of joint prosthesis † 1     
# participants affected / at risk   1/565 (0.18%)   0/283 (0.00%) 
Humerus fracture † 1     
# participants affected / at risk   1/565 (0.18%)   0/283 (0.00%) 
Metabolism and nutrition disorders     
Dehydration † 1     
# participants affected / at risk   2/565 (0.35%)   0/283 (0.00%) 
Cachexia † 1     
# participants affected / at risk   0/565 (0.00%)   1/283 (0.35%) 
Insulin-requiring type 2 diabetes mellitus † 1     
# participants affected / at risk   0/565 (0.00%)   1/283 (0.35%) 
Type 2 diabetes mellitus † 1     
# participants affected / at risk   1/565 (0.18%)   0/283 (0.00%) 
Musculoskeletal and connective tissue disorders     
Back pain † 1     
# participants affected / at risk   1/565 (0.18%)   0/283 (0.00%) 
Intervertebral disc protrusion † 1     
# participants affected / at risk   1/565 (0.18%)   0/283 (0.00%) 
Lumbar spinal stenosis † 1     
# participants affected / at risk   0/565 (0.00%)   1/283 (0.35%) 
Muscular weakness † 1     
# participants affected / at risk   1/565 (0.18%)   0/283 (0.00%) 
Pathological fracture † 1     
# participants affected / at risk   0/565 (0.00%)   1/283 (0.35%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Colon cancer † 1     
# participants affected / at risk   0/565 (0.00%)   2/283 (0.71%) 
Metastases to lung † 1     
# participants affected / at risk   2/565 (0.35%)   0/283 (0.00%) 
Small cell lung cancer stage unspecified † 1     
# participants affected / at risk   2/565 (0.35%)   0/283 (0.00%) 
Chronic myelomonocytic leukaemia † 1     
# participants affected / at risk   1/565 (0.18%)   0/283 (0.00%) 
Gastric cancer † 1     
# participants affected / at risk   1/565 (0.18%)   0/283 (0.00%) 
Intestinal adenocarcinoma † 1     
# participants affected / at risk   1/565 (0.18%)   0/283 (0.00%) 
Laryngeal cancer † 1     
# participants affected / at risk   1/565 (0.18%)   0/283 (0.00%) 
Lung neoplasm † 1     
# participants affected / at risk   1/565 (0.18%)   0/283 (0.00%) 
Metastases to central nervous system † 1     
# participants affected / at risk   1/565 (0.18%)   0/283 (0.00%) 
Metastases to liver † 1     
# participants affected / at risk   1/565 (0.18%)   0/283 (0.00%) 
Metastatic carcinoma of the bladder † 1     
# participants affected / at risk   0/565 (0.00%)   1/283 (0.35%) 
Pancreatic neoplasm † 1     
# participants affected / at risk   0/565 (0.00%)   1/283 (0.35%) 
Prostate cancer † 1     
# participants affected / at risk   1/565 (0.18%)   0/283 (0.00%) 
Renal cancer † 1     
# participants affected / at risk   1/565 (0.18%)   0/283 (0.00%) 
Renal cancer metastatic † 1     
# participants affected / at risk   1/565 (0.18%)   0/283 (0.00%) 
Small cell lung cancer metastatic † 1     
# participants affected / at risk   1/565 (0.18%)   0/283 (0.00%) 
Squamous cell carcinoma of skin † 1     
# participants affected / at risk   1/565 (0.18%)   0/283 (0.00%) 
Thyroid cancer † 1     
# participants affected / at risk   1/565 (0.18%)   0/283 (0.00%) 
Tumour local invasion † 1     
# participants affected / at risk   1/565 (0.18%)   0/283 (0.00%) 
Nervous system disorders     
Ischaemic stroke † 1     
# participants affected / at risk   3/565 (0.53%)   1/283 (0.35%) 
Syncope † 1     
# participants affected / at risk   3/565 (0.53%)   0/283 (0.00%) 
Carotid artery stenosis † 1     
# participants affected / at risk   1/565 (0.18%)   0/283 (0.00%) 
Cerebrovascular accident † 1     
# participants affected / at risk   1/565 (0.18%)   0/283 (0.00%) 
Encephalopathy † 1     
# participants affected / at risk   0/565 (0.00%)   1/283 (0.35%) 
Haemorrhagic stroke † 1     
# participants affected / at risk   0/565 (0.00%)   1/283 (0.35%) 
Parkinson's disease † 1     
# participants affected / at risk   1/565 (0.18%)   0/283 (0.00%) 
Transient ischaemic attack † 1     
# participants affected / at risk   1/565 (0.18%)   0/283 (0.00%) 
Psychiatric disorders     
Delirium † 1     
# participants affected / at risk   0/565 (0.00%)   1/283 (0.35%) 
Renal and urinary disorders     
Acute prerenal failure † 1     
# participants affected / at risk   1/565 (0.18%)   0/283 (0.00%) 
Calculus bladder † 1     
# participants affected / at risk   0/565 (0.00%)   1/283 (0.35%) 
Haematuria † 1     
# participants affected / at risk   1/565 (0.18%)   1/283 (0.35%) 
Renal failure † 1     
# participants affected / at risk   1/565 (0.18%)   0/283 (0.00%) 
Renal failure acute † 1     
# participants affected / at risk   0/565 (0.00%)   1/283 (0.35%) 
Renal failure chronic † 1     
# participants affected / at risk   0/565 (0.00%)   1/283 (0.35%) 
Urinary retention † 1     
# participants affected / at risk   1/565 (0.18%)   1/283 (0.35%) 
Urinary tract obstruction † 1     
# participants affected / at risk   1/565 (0.18%)   0/283 (0.00%) 
Respiratory, thoracic and mediastinal disorders     
Pulmonary embolism † 1     
# participants affected / at risk   3/565 (0.53%)   3/283 (1.06%) 
Chronic obstructive pulmonary disease † 1     
# participants affected / at risk   2/565 (0.35%)   2/283 (0.71%) 
Haemoptysis † 1     
# participants affected / at risk   1/565 (0.18%)   1/283 (0.35%) 
Lung disorder † 1     
# participants affected / at risk   1/565 (0.18%)   0/283 (0.00%) 
Pleural effusion † 1     
# participants affected / at risk   1/565 (0.18%)   0/283 (0.00%) 
Pleurisy † 1     
# participants affected / at risk   1/565 (0.18%)   0/283 (0.00%) 
Respiratory failure † 1     
# participants affected / at risk   0/565 (0.00%)   1/283 (0.35%) 
Vascular disorders     
Deep vein thrombosis † 1     
# participants affected / at risk   1/565 (0.18%)   0/283 (0.00%) 
Hypertension † 1     
# participants affected / at risk   1/565 (0.18%)   0/283 (0.00%) 
Peripheral embolism † 1     
# participants affected / at risk   1/565 (0.18%)   1/283 (0.35%) 
Peripheral ischaemia † 1     
# participants affected / at risk   1/565 (0.18%)   0/283 (0.00%) 
† Events were collected by systematic assessment
1 Term from vocabulary, MedDRA 13.0




  Other Adverse Events
  Show 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
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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.


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



Responsible Party: Ferring Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00946920     History of Changes
Other Study ID Numbers: FE200486 CS35
2008-005276-27 ( EudraCT Number )
Study First Received: July 3, 2009
Results First Received: February 14, 2014
Last Updated: May 2, 2014