Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Ferring Pharmaceuticals Korea, Ltd. | OTHER |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This is an open-label, multi-centre single arm trial to investigate efficacy and safety of degarelix in Korean patients with prostate cancer for bridging between CS21 trial (NCT00295750) results.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Degarelix 240/80 mg | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Degarelix 240/80 mg | Drug | 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 maintenance doses 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Cumulative Probability of Testosterone at Castrate Level (≤0.5 ng/mL) From Day 28 to Day 196 | Day 28 to Day 196 |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of Patients With Testosterone Level ≤0.5 ng/mL at Day 3 | At day 3 | |
| Percentage Change in Prostate-specific Antigen (PSA) From Baseline to Day 28 | To Day 28 | |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Clinical Development Support | Ferring Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kyoungbuk National University Hospital | Daegu | Daegu | South Korea | |||
| Hallym University Sacred Heart Hospital |
Not provided
The patients were recruited from 11 sites in Korea. The study was conducted between 08 March 2010 (FPFV) and 07 November 2011 (LPLV).
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Degarelix 240/80 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 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. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
|
| Cumulative Probability of Testosterone at Castrate Level (≤0.5 ng/mL)From Day 56 to Day 196 |
| Day 56 to Day 196 |
| Cumulative Probability of no PSA Failure From Day 28 to Day 196 | PSA failure was defined as two consecutive increases of 50%, and at least 5 ng/mL, compared to nadir. | To Day 196 |
| Number of Participants With Markedly Abnormal Values in Safety Laboratory Variables | 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. | To Day 196 |
| Number of Participants With Markedly Abnormal Values in Vital Signs and Body Weight | 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. | To Day 196 |
| Pyungchon |
| Gyunggi-do |
| South Korea |
| Pusan National University Yangsan Hospital | Mulgeum-eup | Gyungnam | South Korea |
| Seoul National University Bundang Hospital | Seongnam | South Korea |
| Asan Medical Center | Seoul | South Korea |
| Korea University Hospital | Seoul | South Korea |
| Samsung Medical Center | Seoul | South Korea |
| Seoul National University Hospital | Seoul | South Korea |
| Seoul St. Mary's Hospital | Seoul | South Korea |
| Yonsei University Health System (Sevrance Hospital) | Seoul | South Korea |
| Yonsei University Health System Gangnam Sevrance | Seoul | South Korea |
| Full Analysis Set (FAS) |
|
| Safety Analysis Set |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Degarelix 240/80 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 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age Continuous | Mean | Standard Deviation | years |
| ||||||||||||||||||||||
| Sex: Female, Male | Baseline values based on FAS | Count of Participants | Participants |
| ||||||||||||||||||||||
| Region of Enrollment | Number | participants |
| |||||||||||||||||||||||
| Body Mass Index (BMI) | Mean | Standard Deviation | kilogram per square meter |
| ||||||||||||||||||||||
| Gleason Score | 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 | Number | Participants |
| ||||||||||||||||||||||
| Stage of Prostate Cancer | 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). | Number | Participants |
| ||||||||||||||||||||||
| Serum Testosterone Level | Median | Full Range | nanograms per milliliter (ng/mL) |
| ||||||||||||||||||||||
| Serum Protsate-Specific Antigen (PSA) Levels | Median | Full Range | ng/mL |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Cumulative Probability of Testosterone at Castrate Level (≤0.5 ng/mL) From Day 28 to Day 196 | 152 participants for this outcome measure is the analysis population from day 28 to day 196 | Posted | Mean | 95% Confidence Interval | percent probability | Day 28 to Day 196 |
|
|
| ||||||||||||||||||||||||||
| Secondary | Proportion of Patients With Testosterone Level ≤0.5 ng/mL at Day 3 | Observed cases | Posted | Number | 95% Confidence Interval | percent | At day 3 |
|
| |||||||||||||||||||||||||||
| Secondary | Percentage Change in Prostate-specific Antigen (PSA) From Baseline to Day 28 | 152 participants for this outcome measure is the analysis population from day 0 to day 28 | Posted | Median | Inter-Quartile Range | percent | To Day 28 |
|
| |||||||||||||||||||||||||||
| Secondary | Cumulative Probability of Testosterone at Castrate Level (≤0.5 ng/mL)From Day 56 to Day 196 | 152 participants for this outcome measure is the analysis population from day 56 to day 196 | Posted | Mean | 95% Confidence Interval | percent probability | Day 56 to Day 196 |
|
| |||||||||||||||||||||||||||
| Secondary | Cumulative Probability of no PSA Failure From Day 28 to Day 196 | PSA failure was defined as two consecutive increases of 50%, and at least 5 ng/mL, compared to nadir. | 152 participants for this outcome measure is the analysis population from day 28 to day 196 | Posted | Mean | 95% Confidence Interval | percent probability | To Day 196 |
|
| ||||||||||||||||||||||||||
| Secondary | Number of Participants With Markedly Abnormal Values in Safety Laboratory Variables | 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. | Safety analysis population | Posted | Number | participants | To Day 196 |
|
| |||||||||||||||||||||||||||
| Secondary | Number of Participants With Markedly Abnormal Values in Vital Signs and Body Weight | 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. | Safety analyis population | Posted | Number | participants | To Day 196 |
|
|
7 months (196 days)
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.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Degarelix 240/80 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 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. | 18 | 156 | 113 | 156 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Angina pectoris | Cardiac disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Angina unstable | Cardiac disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Coronary artery occlusion | Cardiac disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Myocardial ischaemia | Cardiac disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Inguinal hernia | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Disease progression | General disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Appendicitis | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
| |
| Herpes zoster | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
| |
| Drug toxicity | Injury, poisoning and procedural complications | MedDRA 12.0 | Systematic Assessment |
| |
| Spinal compression fracture | Injury, poisoning and procedural complications | MedDRA 12.0 | Systematic Assessment |
| |
| Anorexia | Metabolism and nutrition disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Flank pain | Musculoskeletal and connective tissue disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Metastases to prostate | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 12.0 | Systematic Assessment |
| |
| Metastatic pain | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 12.0 | Systematic Assessment |
| |
| Paraplegia | Nervous system disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Spinal cord compression | Nervous system disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Dysuria | Renal and urinary disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Haematuria | Renal and urinary disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Urinary retention | Renal and urinary disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Pelvic pain | Reproductive system and breast disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Penile pain | Reproductive system and breast disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Perineal pain | Reproductive system and breast disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Ureteral stent removal | Surgical and medical procedures | MedDRA 12.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Constipation | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Injection site pain | General disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Injection site erythema | General disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Injection site induration | General disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Upper respiratory tract | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Insomnia | Nervous system disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Nocturia | Renal and urinary disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Dysuria | Renal and urinary disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Haematuria | Renal and urinary disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Hyperhidrosis | Skin and subcutaneous tissue disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Hot flush | Vascular disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Flushing | Vascular disorders | MedDRA 12.0 | Systematic Assessment |
|
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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Ferring Pharmaceuticals | Clinical Development Support | DK0-Disclosure@ferring.com |
| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C431566 | acetyl-2-naphthylalanyl-3-chlorophenylalanyl-1-oxohexadecyl-seryl-4-aminophenylalanyl(hydroorotyl)-4-aminophenylalanyl(carbamoyl)-leucyl-ILys-prolyl-alaninamide |
Not provided
Not provided
Not provided
| Gleason Score 7-10 |
|
|
| Metastatic |
|
| Not Classifiable |
|
| Title | Denominators | Categories | ||||
|---|---|---|---|---|---|---|
|
|
|
|
|
|