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The purpose of this trial was to select a dose of degarelix (FE 200486). Three groups of patients were treated for six months on different doses. The patients had blood samples taken and measured for Testosterone in order to determine the most efficient dose to provide fast and sustained castration. The patients came to the clinic for 16 visits and dependent on the blood sample results they were invited to return for additional blood samples on a two weekly basis.
Degarelix was not FDA regulated at the time of the trial. After completion of the trial degarelix has been approved by the FDA and is thus an FDA regulated intervention.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Degarelix 80/80 + 40 | Experimental | Loading doses of Degarelix 80 mg (20 mg/mL) on Days 0 and 3. Maintenance doses of 40 mg (20 mg/mL) given on days 28, 56, 84, 112 and 140. |
|
| Degarelix 40/40 + 40 | Experimental | Loading doses of Degarelix 40 mg (20 mg/mL) on Days 0 and 3. Maintenance doses of 40 mg (20 mg/mL) given on days 28, 56, 84, 112 and 140. |
|
| Degarelix 80 + 20 | Experimental | Loading dose of Degarelix 80 mg (20 mg/mL) on Day 0. Maintenance doses of 20 mg (10 mg/mL) given on days 28, 56, 84, 112 and 140. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Degarelix | Drug | Given as a subcutaneous injection. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Testosterone <0.5 Nanogram/Milliliter | Weeks 1,2,4,8,12,16,20,24 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Testosterone < 0.5 Nanogram/Milliliter at All Visits Between Weeks 4-24 | Weeks 4-24 | |
| Number of Participants Not Meeting a Testosterone Withdrawal Criterion Between Weeks 4-24 | Participants with one testoterone value > 1.0 nanogram/millliliter or two consecutive values between 0.5-1.0 nanogram/milliliter were withdrawn from the study due to insufficient response. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Development Support | Ferring Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ayr Hospital | Ayr | United Kingdom | ||||
| Bristol Royal Infirmary |
One hundred and fifty-nine participants were screened. One hundred and twenty-nine participants were randomised, two of these participants withdrew before receiving any treatment.
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| ID | Title | Description |
|---|---|---|
| FG000 | Degarelix 80/80 + 40 | Loading doses of Degarelix 80 mg on Days 0 and 3. Maintenance doses of 40 mg given on days 28, 56, 84, 112 and 140. |
| FG001 | Degarelix 40/40 + 40 | Loading doses of Degarelix 40 mg on Days 0 and 3. Maintenance doses of 40 mg given on days 28, 56, 84, 112 and 140. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Weeks 4-24 |
| Number of Participants Who Met the Withdrawl Criteria for Prostate-specific Antigen | Participants who met at least one of the three criteria for inadequate response on prostate-specific antigen levels (PA). (1) >=25 percent and/or 50 nanogram/milliliter compared to baseline (2) reduction of <=50% compared to baseline at week 12 (3) increase of >=10 nanogram/milliliter compared to nadir from week 4. | Six months |
| Number of Participants With Normal Prostate-specific Antigen Levels During the Study | The number of participants whose prostate-specific antigen levels at weeks 12 and 24 were <= 4 nanogram/millliliter (normal level). | Weeks 12, 24 |
| The Number of Participants With Abnormal Liver Function Tests | The number of participants who had abnormal [defined as above upper limit of normal range (ULN)] alanine aminotransferase (ALT), participants with ALT increases > 3x ULN, and participants with ALT increases > 3x ULN with concurrent increases in bilirubin > 1.5 ULN. | Six months |
| Percentage Change in Vital Signs and Body Weight | Percentage changes in vital signs (systolic and diastolic blood pressure and pulse) and body weight at the end of trial as compared to baseline. | Baseline and Six months |
| Bristol |
| United Kingdom |
| Southmead Hospital | Bristol | United Kingdom |
| St. Richards Hospital | Chichester | United Kingdom |
| Glan Clwyd Hospital | Denbighshire | United Kingdom |
| Ninewells Hospital | Dundee | United Kingdom |
| Southern General Hospital | Glasgow | United Kingdom |
| Leicester General Hospital | Leicester | United Kingdom |
| Chelsea and Westminster Hospital | London | United Kingdom |
| Kings College Hospital | London | United Kingdom |
| St. Bartholemews Hospital | London | United Kingdom |
| Derriford Hospital | Plymouth | United Kingdom |
| Lister Hospital | Stevenage | United Kingdom |
| Stirling Royal Infirmary | Stirling | United Kingdom |
| Morriston Hospital | Swansea | United Kingdom |
| Pindersfields General Hospital | Wakefield | United Kingdom |
| FG002 | Degarelix 80 + 20 | Loading dose of Degarelix 80 mg on Day 0. Maintenance doses of 20 mg given on days 28, 56, 84, 112 and 140. |
| Randomized |
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| Intent-to-treat Population |
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| Per Protocol Population |
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| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Degarelix 80/80 + 40 | Loading doses of Degarelix 80 mg on Days 0 and 3. Maintenance doses of 40 mg given on days 28, 56, 84, 112 and 140. |
| BG001 | Degarelix 40/40 + 40 | Loading doses of Degarelix 40 mg on Days 0 and 3. Maintenance doses of 40 mg given on days 28, 56, 84, 112 and 140. |
| BG002 | Degarelix 80 + 20 | Loading dose of Degarelix 80 mg on Day 0. Maintenance doses of 20 mg given on days 28, 56, 84, 112 and 140. |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race/Ethnicity, Customized | Number | participants |
| ||||||||||||||||
| Region of Enrollment | Number | participants |
| ||||||||||||||||
| Participant Counts by Gleason Score | 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. | Number | participants |
| |||||||||||||||
| Stage of Prostate Cancer | 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. | Number | participants |
| |||||||||||||||
| Body Mass Index | Body mass index is a measure of body fat based on height and weight | Median | Full Range | kilogram per square meter |
| ||||||||||||||
| Days Since Diagnosis of Prostate Cancer | The number of days passed since a diagnosis of prostate cancer was made for each participant. | Mean | Standard Deviation | days |
| ||||||||||||||
| Serum Prostate-Specific Antigen level | Prostate-specific antigen (PSA) is a protein produced by the cells of the prostate gland. The PSA test measures the level of PSA in the blood. High PSA levels have a positive correlation to prostate cancer. | Median | Full Range | nanogram/milliliter |
| ||||||||||||||
| Serum Testosterone level | Testosterone is a steroid hormone from the androgen group, and the principal male sex hormone. This test measures the amount of testosterone in the blood. Androgen deprivation is used to manage prostate cancer. | Median | Full Range | nanogram/milliliter |
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| 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 | Number of Participants With Testosterone <0.5 Nanogram/Milliliter | Per protocol population | Posted | Number | participants | Weeks 1,2,4,8,12,16,20,24 |
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| |||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Testosterone < 0.5 Nanogram/Milliliter at All Visits Between Weeks 4-24 | Per protocol population | Posted | Number | participants | Weeks 4-24 |
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| ||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants Not Meeting a Testosterone Withdrawal Criterion Between Weeks 4-24 | Participants with one testoterone value > 1.0 nanogram/millliliter or two consecutive values between 0.5-1.0 nanogram/milliliter were withdrawn from the study due to insufficient response. | Per protocol population | Posted | Number | participants | Weeks 4-24 |
|
| |||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants Who Met the Withdrawl Criteria for Prostate-specific Antigen | Participants who met at least one of the three criteria for inadequate response on prostate-specific antigen levels (PA). (1) >=25 percent and/or 50 nanogram/milliliter compared to baseline (2) reduction of <=50% compared to baseline at week 12 (3) increase of >=10 nanogram/milliliter compared to nadir from week 4. | per protocol population | Posted | Number | participants | Six months |
|
| |||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Normal Prostate-specific Antigen Levels During the Study | The number of participants whose prostate-specific antigen levels at weeks 12 and 24 were <= 4 nanogram/millliliter (normal level). | Per Protocol Population | Posted | Number | participants | Weeks 12, 24 |
|
| |||||||||||||||||||||||||||||||||||
| Secondary | The Number of Participants With Abnormal Liver Function Tests | The number of participants who had abnormal [defined as above upper limit of normal range (ULN)] alanine aminotransferase (ALT), participants with ALT increases > 3x ULN, and participants with ALT increases > 3x ULN with concurrent increases in bilirubin > 1.5 ULN. | Randomized (Safety) population | Posted | Number | participants | Six months |
|
| |||||||||||||||||||||||||||||||||||
| Secondary | Percentage Change in Vital Signs and Body Weight | Percentage changes in vital signs (systolic and diastolic blood pressure and pulse) and body weight at the end of trial as compared to baseline. | Safety population. | Posted | Median | Full Range | percentage | Baseline and Six months |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Degarelix 80/80 + 40 | Loading doses of Degarelix 80 mg on Days 0 and 3. Maintenance doses of 40 mg given on days 28, 56, 84, 112 and 140. | 3 | 38 | ||||
| EG001 | Degarelix 40/40 + 40 | Loading doses of Degarelix 40 mg on Days 0 and 3. Maintenance doses of 40 mg given on days 28, 56, 84, 112 and 140. | 8 | 38 | ||||
| EG002 | Degarelix 80 + 20 | Loading dose of Degarelix 80 mg on Day 0. Maintenance doses of 20 mg given on days 28, 56, 84, 112 and 140. | 6 | 32 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 7.0 | Systematic Assessment |
| |
| Angina pectoris | Cardiac disorders | MedDRA 7.0 | Systematic Assessment |
| |
| Myocardial infarction | Cardiac disorders | MedDRA 7.0 | Systematic Assessment |
| |
| Cardiac failure congestive | Cardiac disorders | MedDRA 7.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 7.0 | Systematic Assessment |
| |
| Rectal haemorrhage | Gastrointestinal disorders | MedDRA 7.0 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 7.0 | Systematic Assessment |
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| Asthenia | General disorders | MedDRA 7.0 | Systematic Assessment |
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| Catheter related complication | General disorders | MedDRA 7.0 | Systematic Assessment |
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| Condition aggravated | General disorders | MedDRA 7.0 | Systematic Assessment |
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| Hepatic function abnormal | Hepatobiliary disorders | MedDRA 7.0 | Systematic Assessment |
| |
| Hypersensitivity | Immune system disorders | MedDRA 7.0 | Systematic Assessment |
| |
| Lobar pneumonia | Infections and infestations | MedDRA 7.0 | Systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA 7.0 | Systematic Assessment |
| |
| Post procedural haemorrhage | Injury, poisoning and procedural complications | MedDRA 7.0 | Systematic Assessment |
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| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 7.0 | Systematic Assessment |
| |
| Lung neoplasm malignant | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 7.0 | Systematic Assessment |
| |
| Cerebral haemorrhage | Nervous system disorders | MedDRA 7.0 | Systematic Assessment |
| |
| Cerebrovascular accident | Nervous system disorders | MedDRA 7.0 | Systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA 7.0 | Systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA 7.0 | Systematic Assessment |
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| Alcoholism | Psychiatric disorders | MedDRA 7.0 | Systematic Assessment |
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| Bladder obstruction | Renal and urinary disorders | MedDRA 7.0 | Systematic Assessment |
| |
| Calculus bladder | Renal and urinary disorders | MedDRA 7.0 | Systematic Assessment |
| |
| Dysuria | Renal and urinary disorders | MedDRA 7.0 | Systematic Assessment |
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| Urine flow decreased | Renal and urinary disorders | MedDRA 7.0 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 7.0 | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhoea | Gastrointestinal disorders | MedDRA 7.0 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 7.0 | Systematic Assessment |
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| Inguinal hernia | Gastrointestinal disorders | MedDRA 7.0 | Systematic Assessment |
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| Dyspepsia | Gastrointestinal disorders | MedDRA 7.0 | Systematic Assessment |
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| Abdominal pain | Gastrointestinal disorders | MedDRA 7.0 | Systematic Assessment |
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| Fatigue | General disorders | MedDRA 7.0 | Systematic Assessment |
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| Suprapubic pain | General disorders | MedDRA 7.0 | Systematic Assessment |
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| Nasopharyngitis | Infections and infestations | MedDRA 7.0 | Systematic Assessment |
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| Urinary tract infection | Infections and infestations | MedDRA 7.0 | Systematic Assessment |
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| Weight increased | Investigations | MedDRA 7.0 | Systematic Assessment |
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| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 7.0 | Systematic Assessment |
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| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 7.0 | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA 7.0 | Systematic Assessment |
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| Lethargy | Nervous system disorders | MedDRA 7.0 | Systematic Assessment |
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| Dysuria | Renal and urinary disorders | MedDRA 7.0 | Systematic Assessment |
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| Pollakiuria | Renal and urinary disorders | MedDRA 7.0 | Systematic Assessment |
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| Testicular atrophy | Reproductive system and breast disorders | MedDRA 7.0 | Systematic Assessment |
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| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 7.0 | Systematic Assessment |
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| Hyperhidrosis | Skin and subcutaneous tissue disorders | MedDRA 7.0 | Systematic Assessment |
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| Skin reaction | Skin and subcutaneous tissue disorders | MedDRA 7.0 | Systematic Assessment |
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| Hot flush | Vascular disorders | MedDRA 7.0 | Systematic Assessment |
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| Flushing | Vascular disorders | MedDRA 7.0 | Systematic Assessment |
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| Hypertension | Vascular disorders | MedDRA 7.0 | 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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Development Support | Ferring Pharmaceuticals | 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 |
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| ID | Term |
|---|---|
| C431566 | acetyl-2-naphthylalanyl-3-chlorophenylalanyl-1-oxohexadecyl-seryl-4-aminophenylalanyl(hydroorotyl)-4-aminophenylalanyl(carbamoyl)-leucyl-ILys-prolyl-alaninamide |
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| Between 18 and 65 years |
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| >=65 years |
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| Male |
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| Black |
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| Oriental / Asian |
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| Afro-carribean |
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| Indian |
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| 2-4 |
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| 5-6 |
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| 7-10 |
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| Locally advanced |
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| Metastatic |
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| Not classifiable |
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| Week 4 (n=38, 36, 33) |
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| Week 8 (n=36, 36, 31) |
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| Week 12 (n=34, 34, 31) |
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| Week 16 (n=34, 32, 30) |
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| Week 20 (n=33, 31, 28) |
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| Week 24 (n=31, 29, 25) |
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| Participants |
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| Participants |
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