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Extension Study Investigating the Long-Term Safety of Degarelix One-Month Depots in Patients With Prostate Cancer

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ClinicalTrials.gov Identifier: NCT00117286
Recruitment Status : Completed
First Posted : July 6, 2005
Results First Posted : October 21, 2010
Last Update Posted : October 21, 2010
Sponsor:
Information provided by:
Ferring Pharmaceuticals

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Prostate Cancer
Intervention Drug: Degarelix
Enrollment 57
Recruitment Details Participants who completed the main FE200486 CS14 study were asked to continue into the FE200486 CS14A extension study.
Pre-assignment Details 127 participants started and 87 participants completed the main CS14 study. Of these, 57 participants were recruited into the extension study CS14A and 34 participants signed the informed consent for dose shift.
Arm/Group Title Degarelix (60 mg to 160 mg) Degarelix (80 mg to 160 mg)
Hide Arm/Group Description Participants who completed the CS14 study in the Degarelix 60 mg (20 mg/mL) arm continued that dose into the CS14A extension study. A protocol amendment in March 2006 changed the dosage to 160 mg (40 mg/mL) for all study participants. Participants who completed the CS14 study in the Degarelix 80 mg (20 mg/mL) arm continued that dose into the CS14A extension study. A protocol amendment in March 2006 changed the dosage to 160 mg (40 mg/mL) for all study participants.
Period Title: Overall Study
Started 30 [1] 27
Switched to Higher Dose 17 [2] 17
Completed 2 [3] 6
Not Completed 28 21
Reason Not Completed
Adverse Event             12             6
Lost to Follow-up             2             0
Protocol Violation             3             3
Withdrawal by Subject             6             2
Physician Decision             3             7
Lack of Efficacy             2             1
Research site closing             0             2
[1]
Safety analysis set
[2]
A protocol amendment changed the dosage to 160 mg (40 mg/mL)
[3]
Participants ongoing at the time of study closure were considered to have completed the study
Arm/Group Title Degarelix (60 mg to 160 mg) Degarelix (80 mg to 160 mg) Total
Hide Arm/Group Description Participants who completed the CS14 study in the Degarelix 60 mg (20 mg/mL) arm continued that dose into the CS14A extension study. A protocol amendment in March 2006 changed the dosage to 160 mg (40 mg/mL) for all study participants. Participants who completed the CS14 study in the Degarelix 80 mg (20 mg/mL) arm continued that dose into the CS14A extension study. A protocol amendment in March 2006 changed the dosage to 160 mg (40 mg/mL) for all study participants. Total of all reporting groups
Overall Number of Baseline Participants 30 27 57
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous   [1] 
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 30 participants 27 participants 57 participants
76.0  (6.63) 74.1  (8.85) 75.1  (7.75)
[1]
Measure Description: Safety analysis set
Sex: Female, Male   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 30 participants 27 participants 57 participants
Female
0
   0.0%
0
   0.0%
0
   0.0%
Male
30
 100.0%
27
 100.0%
57
 100.0%
[1]
Measure Description: Safety analysis set
Race (NIH/OMB)   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 30 participants 27 participants 57 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
1
   3.3%
0
   0.0%
1
   1.8%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
5
  16.7%
2
   7.4%
7
  12.3%
White
24
  80.0%
25
  92.6%
49
  86.0%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
[1]
Measure Description: Safety analysis set
Body weight   [1] 
Mean (Standard Deviation)
Unit of measure:  Kilogram
Number Analyzed 30 participants 27 participants 57 participants
79.0  (11.4) 81.3  (13.3) 80.1  (12.2)
[1]
Measure Description: Safety analysis set
Body mass index   [1] 
Mean (Standard Deviation)
Unit of measure:  Kilogram per square meter
Number Analyzed 30 participants 27 participants 57 participants
26.5  (3.64) 26.6  (4.63) 26.5  (4.10)
[1]
Measure Description: Safety analysis set
Curative Intent   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 30 participants 27 participants 57 participants
Yes 11 11 22
No 19 16 35
[1]
Measure Description: Safety analysis set. A curative intent of Yes refers to participants who have been castrated via radical prostatectomy or radiotherapy.
Gleason Score   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 30 participants 27 participants 57 participants
2-4 2 1 3
5-6 5 8 13
7-10 23 18 41
[1]
Measure Description: Safety analysis set. 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.
Stage of Prostate Cancer   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 30 participants 27 participants 57 participants
Localized 14 7 21
Locally advanced 3 5 8
Metastatic 5 5 10
Not classifiable 8 10 18
[1]
Measure Description: Safety analysis set. 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.
Time since Prostate Cancer Diagnosis   [1] 
Mean (Standard Deviation)
Unit of measure:  Days
Number Analyzed 30 participants 27 participants 57 participants
1253  (1565) 1349  (1625) 1299  (1580)
[1]
Measure Description: Safety analysis set
1.Primary Outcome
Title Participants With Markedly Abnormal Change in Vital Signs and Body Weight
Hide Description This outcome measure included incidence of markedly abnormal changes in blood pressure (systolic and diastolic), pulse, and body weight at the end of trial as compared to baseline. The table presents the number of participants in each group with normal baseline and markedly abnormal value post-baseline.
Time Frame 5 years
Hide Outcome Measure Data
Hide Analysis Population Description
The data include data from participants participating in both the main study (FE200486 CS14) and the extension study FE200486 CS14A.
Arm/Group Title Degarelix (60 mg to 160 mg) Degarelix (80 mg to 160 mg)
Hide Arm/Group Description:
Participants who completed the CS14 study in the Degarelix 60 mg (20 mg/mL) arm continued that dose into the CS14A extension study. A protocol amendment in March 2006 changed the dosage to 160 mg (40 mg/mL) for all study participants.
Participants who completed the CS14 study in the Degarelix 80 mg (20 mg/mL) arm continued that dose into the CS14A extension study. A protocol amendment in March 2006 changed the dosage to 160 mg (40 mg/mL) for all study participants.
Overall Number of Participants Analyzed 30 27
Measure Type: Number
Unit of Measure: participants
Diastolic blood pressure <=50 and decrease >=15 9 4
Diastolic blood pressure >=105 and increase >=15 3 3
Systolic blood pressure <=90 and decrease >=20 3 7
Systolic blood pressure >=180 and increase >=20 5 4
Heart rate <=50 and decrease >=15 2 6
Heart rate >=120 and increase >=15 1 0
Body weight decrease of >=7 percent 6 4
Body weight increase of >=7 percent 6 5
2.Primary Outcome
Title Liver Function Tests
Hide Description The figures present the number of participants who had abnormal (defined as above upper limit of normal range (ULN)) alanine aminotransferase (ALT) levels, aspartate aminotransferase levels, and bilirubin levels plus the number of participants who had ALT increases >3x ULN and ALT increases >3x ULN with concurrently increased bilirubin >1.5 ULN.
Time Frame 5 years
Hide Outcome Measure Data
Hide Analysis Population Description
The data include data from participants participating in both the main study (FE200486 CS14) and the extension study FE200486 CS14A.
Arm/Group Title Degarelix (60 mg to 160 mg) Degarelix (80 mg to 160 mg)
Hide Arm/Group Description:
Participants who completed the CS14 study in the Degarelix 60 mg (20 mg/mL) arm continued that dose into the CS14A extension study. A protocol amendment in March 2006 changed the dosage to 160 mg (40 mg/mL) for all study participants.
Participants who completed the CS14 study in the Degarelix 80 mg (20 mg/mL) arm continued that dose into the CS14A extension study. A protocol amendment in March 2006 changed the dosage to 160 mg (40 mg/mL) for all study participants.
Overall Number of Participants Analyzed 30 27
Measure Type: Number
Unit of Measure: participants
Abnormal alanine aminotransferase (ALAT) 8 11
Abnormal aspartate aminotransferase 5 4
Abnormal bilirubin 7 5
ALAT >3x upper limit of normal (ULN) 0 0
ALAT >3x ULN, bilirubin >1.5x ULN 0 0
Time Frame 5 years.
Adverse Event Reporting Description Each participant’s condition was monitored throughout the trial from the time of signing the informed consent until the end of the follow-up period. The investigator was to record all adverse events (AEs) in the AE log of the participant’s Case Report Form.
 
Arm/Group Title Degarelix (60 mg to 160 mg) Degarelix (80 mg to 160 mg)
Hide Arm/Group Description Participants who completed the CS14 study in the Degarelix 60 mg (20 mg/mL) arm continued that dose into the CS14A extension study. A protocol amendment in March 2006 changed the dosage to 160 mg (40 mg/mL) for all study participants. Participants who completed the CS14 study in the Degarelix 80 mg (20 mg/mL) arm continued that dose into the CS14A extension study. A protocol amendment in March 2006 changed the dosage to 160 mg (40 mg/mL) for all study participants.
All-Cause Mortality
Degarelix (60 mg to 160 mg) Degarelix (80 mg to 160 mg)
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Degarelix (60 mg to 160 mg) Degarelix (80 mg to 160 mg)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   11/30 (36.67%)      7/27 (25.93%)    
Cardiac disorders     
Cardiac failure congestive  1  1/30 (3.33%)  1 0/27 (0.00%)  0
Coronary artery disease  1  0/30 (0.00%)  0 1/27 (3.70%)  1
Ear and labyrinth disorders     
Vertigo  1  0/30 (0.00%)  0 1/27 (3.70%)  1
Gastrointestinal disorders     
Hiatus hernia  1  2/30 (6.67%)  2 0/27 (0.00%)  0
Diverticulum  1  1/30 (3.33%)  1 0/27 (0.00%)  0
Inguinal hernia, obstructive  1  0/30 (0.00%)  0 1/27 (3.70%)  1
Nausea  1  0/30 (0.00%)  0 1/27 (3.70%)  1
General disorders     
Asthenia  1  0/30 (0.00%)  0 1/27 (3.70%)  1
General physcial health deterioration  1  0/30 (0.00%)  0 1/27 (3.70%)  1
Infections and infestations     
Pneumonia  1  3/30 (10.00%)  3 0/27 (0.00%)  0
Appendiceal abscess  1  1/30 (3.33%)  1 0/27 (0.00%)  0
Appendicitis perforated  1  1/30 (3.33%)  1 0/27 (0.00%)  0
Gastroenteritis viral  1  1/30 (3.33%)  1 0/27 (0.00%)  0
Respiratory tract infection  1  1/30 (3.33%)  1 0/27 (0.00%)  0
Injury, poisoning and procedural complications     
Pelvic fracture  1  1/30 (3.33%)  1 0/27 (0.00%)  0
Musculoskeletal and connective tissue disorders     
Lumbar spinal stenosis  1  0/30 (0.00%)  0 1/27 (3.70%)  1
Muscular weakness  1  1/30 (3.33%)  1 0/27 (0.00%)  0
Osteoarthritis  1  0/30 (0.00%)  0 1/27 (3.70%)  1
Osteonecrosis  1  0/30 (0.00%)  0 1/27 (3.70%)  1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Metastasis to central nervous system  1  1/30 (3.33%)  1 0/27 (0.00%)  0
Prostate cancer  1  0/30 (0.00%)  0 1/27 (3.70%)  1
Sarcoma  1  1/30 (3.33%)  1 0/27 (0.00%)  0
Nervous system disorders     
Carotid artery occlusion  1  1/30 (3.33%)  1 0/27 (0.00%)  0
Subarachnoid haemorrhage  1  1/30 (3.33%)  1 0/27 (0.00%)  0
Transient ischaemic attack  1  1/30 (3.33%)  1 0/27 (0.00%)  0
Renal and urinary disorders     
Urinary retention  1  0/30 (0.00%)  0 1/27 (3.70%)  1
Respiratory, thoracic and mediastinal disorders     
Chronic obstructive pulmonary disease  1  1/30 (3.33%)  4 1/27 (3.70%)  2
Skin and subcutaneous tissue disorders     
Hyperhidrosis  1  0/30 (0.00%)  0 1/27 (3.70%)  1
Vascular disorders     
Aortic aneurysm  1  0/30 (0.00%)  0 1/27 (3.70%)  1
Deep vein thrombosis  1  1/30 (3.33%)  1 0/27 (0.00%)  0
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (12.0)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Degarelix (60 mg to 160 mg) Degarelix (80 mg to 160 mg)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   29/30 (96.67%)      26/27 (96.30%)    
Blood and lymphatic system disorders     
Anaemia  1  4/30 (13.33%)  4 2/27 (7.41%)  2
Cardiac disorders     
Atrioventricular block first degree  1  2/30 (6.67%)  2 1/27 (3.70%)  1
Myocardial infarction  1  2/30 (6.67%)  2 1/27 (3.70%)  1
Bundle branch block left  1  2/30 (6.67%)  2 0/27 (0.00%)  0
Myocardial ischaemia  1  0/30 (0.00%)  0 2/27 (7.41%)  2
Eye disorders     
Cataract  1  2/30 (6.67%)  3 4/27 (14.81%)  4
Gastrointestinal disorders     
Constipation  1  2/30 (6.67%)  2 5/27 (18.52%)  5
Nausea  1  5/30 (16.67%)  6 2/27 (7.41%)  2
Colonic polyp  1  1/30 (3.33%)  1 3/27 (11.11%)  3
Abdominal pain  1  2/30 (6.67%)  2 1/27 (3.70%)  1
Vomiting  1  3/30 (10.00%)  4 0/27 (0.00%)  0
Gastrooesophageal reflux disease  1  2/30 (6.67%)  2 0/27 (0.00%)  0
Inguinal hernia  1  2/30 (6.67%)  2 0/27 (0.00%)  0
General disorders     
Fatigue  1  8/30 (26.67%)  11 5/27 (18.52%)  9
Injection site pain  1  7/30 (23.33%)  18 6/27 (22.22%)  19
Injection site nodule  1  7/30 (23.33%)  16 5/27 (18.52%)  14
Injection site erythema  1  3/30 (10.00%)  18 5/27 (18.52%)  14
Chills  1  2/30 (6.67%)  4 5/27 (18.52%)  8
Injection site induration  1  1/30 (3.33%)  1 4/27 (14.81%)  6
Oedema peripheral  1  2/30 (6.67%)  2 2/27 (7.41%)  5
Injection site haematoma  1  2/30 (6.67%)  2 1/27 (3.70%)  4
Injection site mass  1  1/30 (3.33%)  6 2/27 (7.41%)  2
Injection site reaction  1  1/30 (3.33%)  1 2/27 (7.41%)  3
Pain  1  2/30 (6.67%)  3 1/27 (3.70%)  2
Pyrexia  1  1/30 (3.33%)  1 2/27 (7.41%)  3
Asthenia  1  0/30 (0.00%)  0 2/27 (7.41%)  2
Chest discomfort  1  0/30 (0.00%)  0 2/27 (7.41%)  3
Injection site warmth  1  0/30 (0.00%)  0 2/27 (7.41%)  2
Infections and infestations     
Nasopharyngitis  1  5/30 (16.67%)  9 6/27 (22.22%)  8
Upper respiratory tract infection  1  5/30 (16.67%)  5 6/27 (22.22%)  7
Urinary tract infection  1  3/30 (10.00%)  3 1/27 (3.70%)  1
Bronchitis  1  2/30 (6.67%)  2 1/27 (3.70%)  1
Tooth abscess  1  2/30 (6.67%)  2 1/27 (3.70%)  1
Influenza  1  2/30 (6.67%)  3 0/27 (0.00%)  0
Injury, poisoning and procedural complications     
Contusion  1  2/30 (6.67%)  2 1/27 (3.70%)  1
Procedural pain  1  2/30 (6.67%)  2 1/27 (3.70%)  1
Fall  1  2/30 (6.67%)  2 0/27 (0.00%)  0
Tooth fracture  1  2/30 (6.67%)  2 0/27 (0.00%)  0
Investigations     
Weight increased  1  4/30 (13.33%)  4 7/27 (25.93%)  7
Prostatic specific antigen increased  1  5/30 (16.67%)  5 1/27 (3.70%)  1
Weight decreased  1  2/30 (6.67%)  3 2/27 (7.41%)  2
Gamma-glutamyltransferase increased  1  2/30 (6.67%)  3 1/27 (3.70%)  1
Haemoglobin decreased  1  3/30 (10.00%)  3 0/27 (0.00%)  0
Blood creatinine increased  1  2/30 (6.67%)  2 0/27 (0.00%)  0
Cardiac murmur  1  0/30 (0.00%)  0 2/27 (7.41%)  2
Metabolism and nutrition disorders     
Decreased appetite  1  3/30 (10.00%)  3 2/27 (7.41%)  2
Hyperlipidaemia  1  2/30 (6.67%)  3 2/27 (7.41%)  2
Diabetes mellitus  1  2/30 (6.67%)  2 1/27 (3.70%)  1
Hyperkalaemia  1  3/30 (10.00%)  3 0/27 (0.00%)  0
Musculoskeletal and connective tissue disorders     
Arthralgia  1  3/30 (10.00%)  3 5/27 (18.52%)  5
Back pain  1  1/30 (3.33%)  1 6/27 (22.22%)  6
Arthritis  1  1/30 (3.33%)  1 4/27 (14.81%)  4
Musculoskeletal pain  1  2/30 (6.67%)  2 3/27 (11.11%)  3
Bursitis  1  0/30 (0.00%)  0 2/27 (7.41%)  2
Pain in extremity  1  0/30 (0.00%)  0 2/27 (7.41%)  2
Rotator cuff syndrome  1  0/30 (0.00%)  0 2/27 (7.41%)  3
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Basal cell carcinoma  1  2/30 (6.67%)  2 0/27 (0.00%)  0
Nervous system disorders     
Dizziness  1  4/30 (13.33%)  6 5/27 (18.52%)  6
Headache  1  2/30 (6.67%)  2 2/27 (7.41%)  3
Psychiatric disorders     
Insomnia  1  3/30 (10.00%)  4 3/27 (11.11%)  3
Anxiety  1  3/30 (10.00%)  3 0/27 (0.00%)  0
Renal and urinary disorders     
Pollakiuria  1  3/30 (10.00%)  3 3/27 (11.11%)  3
Dysuria  1  1/30 (3.33%)  1 4/27 (14.81%)  5
Micturition urgency  1  2/30 (6.67%)  2 3/27 (11.11%)  4
Nocturia  1  0/30 (0.00%)  0 5/27 (18.52%)  8
Haematuria  1  1/30 (3.33%)  1 2/27 (7.41%)  2
Renal failure  1  2/30 (6.67%)  2 0/27 (0.00%)  0
Urethral stenosis  1  0/30 (0.00%)  0 2/27 (7.41%)  2
Urinary incontinence  1  2/30 (6.67%)  3 0/27 (0.00%)  0
Reproductive system and breast disorders     
Gynaecomastia  1  2/30 (6.67%)  2 2/27 (7.41%)  4
Benign prostatic hyperplasia  1  2/30 (6.67%)  2 1/27 (3.70%)  1
Erectile dysfunction  1  1/30 (3.33%)  1 2/27 (7.41%)  2
Pruritus genital  1  2/30 (6.67%)  2 0/27 (0.00%)  0
Respiratory, thoracic and mediastinal disorders     
Dyspnoea  1  4/30 (13.33%)  4 2/27 (7.41%)  2
Cough  1  4/30 (13.33%)  5 1/27 (3.70%)  3
Nasal congestion  1  2/30 (6.67%)  2 3/27 (11.11%)  3
Epistaxis  1  2/30 (6.67%)  2 0/27 (0.00%)  0
Pleural effusion  1  2/30 (6.67%)  2 0/27 (0.00%)  0
Skin and subcutaneous tissue disorders     
Rash  1  5/30 (16.67%)  7 5/27 (18.52%)  6
Actinic keratosis  1  2/30 (6.67%)  2 2/27 (7.41%)  2
Hyperhidrosis  1  2/30 (6.67%)  2 0/27 (0.00%)  0
Vascular disorders     
Hot flush  1  12/30 (40.00%)  15 15/27 (55.56%)  19
Hypertension  1  4/30 (13.33%)  4 4/27 (14.81%)  6
Hypotension  1  0/30 (0.00%)  0 4/27 (14.81%)  4
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (12.0)
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 only disclosure restriction on the PI is that the sponsor can review the draft manuscript prior to publication and can request delay of publication where any contents are deemed patentable by the sponsor or confidential to the sponsor. Comments will be given within four weeks from receipt of the draft manuscript.
Results Point of Contact
Name/Title: Ferring Pharmaceuticals
Organization: Clinical Development Support
Responsible Party: Clinical Development Support, Ferring Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00117286     History of Changes
Other Study ID Numbers: FE200486 CS14A
First Submitted: June 30, 2005
First Posted: July 6, 2005
Results First Submitted: September 29, 2010
Results First Posted: October 21, 2010
Last Update Posted: October 21, 2010