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Efficacy and Safety of Degarelix One Month Dosing Regimen in Korean Patients With Prostate Cancer

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ClinicalTrials.gov Identifier: NCT01071915
Recruitment Status : Completed
First Posted : February 19, 2010
Results First Posted : February 12, 2013
Last Update Posted : February 12, 2013
Sponsor:
Collaborator:
Ferring Pharmaceuticals Korea, Ltd.
Information provided by (Responsible Party):
Ferring Pharmaceuticals

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Prostate Cancer
Intervention Drug: Degarelix 240/80 mg
Enrollment 157
Recruitment Details The patients were recruited from 11 sites in Korea. The study was conducted between 08 March 2010 (FPFV) and 07 November 2011 (LPLV).
Pre-assignment Details  
Arm/Group Title Degarelix 240/80 mg
Hide Arm/Group Description 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 subsequent maintenace of 80 mg (20 mg/mL) degarelix were administered as single 4 mL s.c. injections at 28 day intervals from day 28 to day 168.
Period Title: Overall Study
Started 157 [1]
Full Analysis Set (FAS) 155
Safety Analysis Set 156
Completed 148
Not Completed 9
Reason Not Completed
Adverse Event             3
Physician Decision             2
Withdrawal by Subject             2
Miscellaneous Reasons             2
[1]
Intention to Treat Analysis Set
Arm/Group Title Degarelix 240/80 mg
Hide Arm/Group Description 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 subsequent maintenace of 80 mg (20 mg/mL) degarelix were administered as single 4 mL s.c. injections at 28 day intervals from day 28 to day 168.
Overall Number of Baseline Participants 155
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 155 participants
72.6  (8.08)
Sex: Female, Male   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 155 participants
Female
0
   0.0%
Male
155
 100.0%
[1]
Measure Description: Baseline values based on FAS
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Korea, Republic of Number Analyzed 155 participants
155
Body Mass Index (BMI)  
Mean (Standard Deviation)
Unit of measure:  Kilogram per square meter
Number Analyzed 155 participants
23.8  (2.98)
Gleason Score   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 155 participants
Gleason Score 2-4 0
Gleason Score 5-6 24
Gleason Score 7-10 130
[1]
Measure Description:

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.

1 patient did not have a Gleason Score

Stage of Prostate Cancer   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 155 participants
Localized 43
Locally Advanced 60
Metastatic 39
Not Classifiable 13
[1]
Measure Description: 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 (13 participants).
Serum Testosterone Level  
Median (Full Range)
Unit of measure:  Nanograms per milliliter (ng/mL)
Number Analyzed 155 participants
4.03
(1.08 to 10.7)
Serum Protsate-Specific Antigen (PSA) Levels  
Median (Full Range)
Unit of measure:  ng/mL
Number Analyzed 155 participants
19.2
(1.59 to 100)
1.Primary Outcome
Title Cumulative Probability of Testosterone at Castrate Level (≤0.5 ng/mL) From Day 28 to Day 196
Hide Description [Not Specified]
Time Frame Day 28 to Day 196
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
152 participants for this outcome measure is the analysis population from day 28 to day 196
Arm/Group Title Degarelix 240/80 mg
Hide Arm/Group Description:
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 subsequent maintenace of 80 mg (20 mg/mL) degarelix were administered as single 4 mL s.c. injections at 28 day intervals from day 28 to day 168.
Overall Number of Participants Analyzed 152
Mean (95% Confidence Interval)
Unit of Measure: percent probability
96.7
(92.2 to 98.6)
2.Secondary Outcome
Title Proportion of Patients With Testosterone Level ≤0.5 ng/mL at Day 3
Hide Description [Not Specified]
Time Frame At day 3
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Observed cases
Arm/Group Title Degarelix 240/80 mg
Hide Arm/Group Description:
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 subsequent maintenace of 80 mg (20 mg/mL) degarelix were administered as single 4 mL s.c. injections at 28 day intervals from day 28 to day 168.
Overall Number of Participants Analyzed 154
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percent
97.4
(93.5 to 99.3)
3.Secondary Outcome
Title Percentage Change in Prostate-specific Antigen (PSA) From Baseline to Day 28
Hide Description [Not Specified]
Time Frame To Day 28
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
152 participants for this outcome measure is the analysis population from day 0 to day 28
Arm/Group Title Degarelix 240/80 mg
Hide Arm/Group Description:
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 subsequent maintenace of 80 mg (20 mg/mL) degarelix were administered as single 4 mL s.c. injections at 28 day intervals from day 28 to day 168.
Overall Number of Participants Analyzed 152
Median (Inter-Quartile Range)
Unit of Measure: percent
-79.7
(-90.5 to -64.5)
4.Secondary Outcome
Title Cumulative Probability of Testosterone at Castrate Level (≤0.5 ng/mL)From Day 56 to Day 196
Hide Description [Not Specified]
Time Frame Day 56 to Day 196
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
152 participants for this outcome measure is the analysis population from day 56 to day 196
Arm/Group Title Degarelix 240/80 mg
Hide Arm/Group Description:
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 subsequent maintenace of 80 mg (20 mg/mL) degarelix were administered as single 4 mL s.c. injections at 28 day intervals from day 28 to day 168.
Overall Number of Participants Analyzed 152
Mean (95% Confidence Interval)
Unit of Measure: percent probability
96.7
(92.2 to 98.6)
5.Secondary Outcome
Title Cumulative Probability of no PSA Failure From Day 28 to Day 196
Hide Description PSA failure was defined as two consecutive increases of 50%, and at least 5 ng/mL, compared to nadir.
Time Frame To Day 196
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
152 participants for this outcome measure is the analysis population from day 28 to day 196
Arm/Group Title Degarelix 240/80 mg
Hide Arm/Group Description:
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 subsequent maintenace of 80 mg (20 mg/mL) degarelix were administered as single 4 mL s.c. injections at 28 day intervals from day 28 to day 168.
Overall Number of Participants Analyzed 152
Mean (95% Confidence Interval)
Unit of Measure: percent probability
97.3
(93.1 to 99.0)
6.Secondary Outcome
Title Number of Participants With Markedly Abnormal Values in Safety Laboratory Variables
Hide Description The figures present the number of participants who had markedly abnormal levels of safety laboratory variables. Only the laboratory variables that had at least one percentage of participants in either group with abnormal value are presented, more variables were included in the study.
Time Frame To Day 196
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Safety analysis population
Arm/Group Title Degarelix 240/80 mg
Hide Arm/Group Description:
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 subsequent maintenace of 80 mg (20 mg/mL) degarelix were administered as single 4 mL s.c. injections at 28 day intervals from day 28 to day 168.
Overall Number of Participants Analyzed 156
Measure Type: Number
Unit of Measure: participants
B-Haematocrit (Ratio) <=0.37 73
B-Haemoglobin (g/L) <=115 5
B-White blood cell count (10^9/L) <=2.8 1
B-White blood cell count (10^9/L) >=16.0 1
B-Red blood cell count (10^12/L) <=3.5 19
S-Alanine aminotransferase (IU/L) >3xULN 1
S-Potassium (mmol/L) >=5.8 10
S-Sodium (mmol/L) <=130 2
S-Urea nitrogen (mmol/L) >=10.7 8
B-Lymphocytes (%) <=10 4
B-Eosinophils (%) >=10 7
7.Secondary Outcome
Title Number of Participants With Markedly Abnormal Values 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. The table presents the number of participants with normal baseline and at least one post-baseline markedly abnormal value.
Time Frame To Day 196
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Safety analyis population
Arm/Group Title Degarelix 240/80 mg
Hide Arm/Group Description:
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 subsequent maintenace of 80 mg (20 mg/mL) degarelix were administered as single 4 mL s.c. injections at 28 day intervals from day 28 to day 168.
Overall Number of Participants Analyzed 156
Measure Type: Number
Unit of Measure: participants
Diastolic blood pressure <=50 and decrease >=15 6
Diastolic blood pressure >=105 and increase >=15 0
Systolic blood pressure <=90 and decrease >=20 12
Systolic blood pressure >=180 and increase >=20 1
Heart rate <=50 and decrease >=15 4
Heart rate >=120 and increase >=15 0
Body weight decrease of >=7 percent 4
Body weight increase of >=7 percent 12
Time Frame 7 months (196 days)
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 240/80 mg
Hide Arm/Group Description 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 subsequent maintenace of 80 mg (20 mg/mL) degarelix were administered as single 4 mL s.c. injections at 28 day intervals from day 28 to day 168.
All-Cause Mortality
Degarelix 240/80 mg
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Degarelix 240/80 mg
Affected / at Risk (%)
Total   18/156 (11.54%) 
Cardiac disorders   
Angina pectoris  1  1/156 (0.64%) 
Angina unstable  1  1/156 (0.64%) 
Atrial fibrillation  1  1/156 (0.64%) 
Coronary artery occlusion  1  1/156 (0.64%) 
Myocardial ischaemia  1  1/156 (0.64%) 
Gastrointestinal disorders   
Constipation  1  1/156 (0.64%) 
Inguinal hernia  1  1/156 (0.64%) 
General disorders   
Asthenia  1  1/156 (0.64%) 
Disease progression  1  1/156 (0.64%) 
Infections and infestations   
Appendicitis  1  1/156 (0.64%) 
Herpes zoster  1  1/156 (0.64%) 
Influenza  1  1/156 (0.64%) 
Upper respiratory tract infection  1  1/156 (0.64%) 
Injury, poisoning and procedural complications   
Drug toxicity  1  1/156 (0.64%) 
Spinal compression fracture  1  1/156 (0.64%) 
Metabolism and nutrition disorders   
Anorexia  1  1/156 (0.64%) 
Hyperglycaemia  1  1/156 (0.64%) 
Musculoskeletal and connective tissue disorders   
Back pain  1  1/156 (0.64%) 
Flank pain  1  1/156 (0.64%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
Metastases to prostate  1  1/156 (0.64%) 
Metastatic pain  1  1/156 (0.64%) 
Nervous system disorders   
Paraplegia  1  1/156 (0.64%) 
Spinal cord compression  1  1/156 (0.64%) 
Renal and urinary disorders   
Dysuria  1  1/156 (0.64%) 
Haematuria  1  1/156 (0.64%) 
Urinary retention  1  1/156 (0.64%) 
Reproductive system and breast disorders   
Pelvic pain  1  1/156 (0.64%) 
Penile pain  1  1/156 (0.64%) 
Perineal pain  1  1/156 (0.64%) 
Respiratory, thoracic and mediastinal disorders   
Dyspnoea  1  1/156 (0.64%) 
Surgical and medical procedures   
Ureteral stent removal  1  1/156 (0.64%) 
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 3%
Degarelix 240/80 mg
Affected / at Risk (%)
Total   113/156 (72.44%) 
Gastrointestinal disorders   
Constipation  1  13/156 (8.33%) 
Diarrhoea  1  7/156 (4.49%) 
Dyspepsia  1  5/156 (3.21%) 
General disorders   
Injection site pain  1  34/156 (21.79%) 
Injection site erythema  1  13/156 (8.33%) 
Injection site induration  1  6/156 (3.85%) 
Oedema peripheral  1  6/156 (3.85%) 
Fatigue  1  5/156 (3.21%) 
Infections and infestations   
Upper respiratory tract  1  12/156 (7.69%) 
Musculoskeletal and connective tissue disorders   
Back pain  1  5/156 (3.21%) 
Nervous system disorders   
Headache  1  7/156 (4.49%) 
Dizziness  1  6/156 (3.85%) 
Insomnia  1  7/156 (4.49%) 
Renal and urinary disorders   
Nocturia  1  10/156 (6.41%) 
Dysuria  1  6/156 (3.85%) 
Haematuria  1  5/156 (3.21%) 
Skin and subcutaneous tissue disorders   
Hyperhidrosis  1  14/156 (8.97%) 
Vascular disorders   
Hot flush  1  5/156 (3.21%) 
Flushing  1  5/156 (3.21%) 
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. Additional time may be required to allow Ferring to seek patent protection of the invention.
Results Point of Contact
Name/Title: Ferring Pharmaceuticals
Organization: Clinical Development Support
Responsible Party: Ferring Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01071915     History of Changes
Other Study ID Numbers: FE200486 CS42
First Submitted: February 18, 2010
First Posted: February 19, 2010
Results First Submitted: October 29, 2012
Results First Posted: February 12, 2013
Last Update Posted: February 12, 2013