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| ID | Type | Description | Link |
|---|---|---|---|
| EudraCT No: 2008-006827-29 |
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Patients that completed any of the trials; CS27 (NCT00738673), CS28 (NCT00831233), CS30 (NCT00833248) or CS31 (NCT00884273) will be given the opportunity to receive monthly doses of degarelix until the drug is launched in their country. Safety parameters such as electrocardiogram (ECG), blood and urine samples and general health state will be studied. Note: patients completing the CS27 trial did not participate in the CS34 trial.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Degarelix | Experimental | The degarelix doses were administered into the abdominal wall every 28 days. For patients treated with goserelin in the previous trials (CS28, CS30 and CS31),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 of 80 mg (20 mg/mL) degarelix were administered as single 4 mL s.c. injections at 28 day intervals from day 28 to the end of the trial. For patients treated with degarelix in the previous trials, maintenance doses of 80 mg (20 mg/mL) degarelix were continued and were administered as single 4 mL s.c. injections at 28 day intervals to the end of the trial. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Degarelix | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Up to 22.5 months |
| 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. | Up to 22.5 months |
Not provided
| Measure | Description | Time Frame |
|---|---|---|
| Serum Levels of Prostate Specific Antigen (PSA)Over Time | PSA levels were measured over time. The table below shows median levels at baseline (n=77 participants), 24 weeks (n=56), 36 weeks (n=58), 48 weeks (n=48), 72 weeks (n=9) | from baseline to 72 weeks |
| Serum Levels of Testosterone Over Time |
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 |
|---|---|---|---|---|---|---|
| Institut Jules Bordet | Brussels | Belgium | ||||
| St. Elisabethziekenhuis |
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The patients were recruited from 16 sites in Belgium, France, Italy, Spain, Sweden and Turkey. The study was conducted between 31 August 2009 (FPFV) and 29 November 2011 (LPLV).
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| ID | Title | Description |
|---|---|---|
| FG000 | Degarelix | The degarelix doses were administered into the abdominal wall every 28 days. For patients treated with goserelin in the previous trials (CS28, CS30 and CS31),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 of 80 mg (20 mg/mL) degarelix were administered as single 4 mL s.c. injections at 28 day intervals from day 28 to the end of the trial. For patients treated with degarelix in the previous trials, maintenance doses of 80 mg (20 mg/mL) degarelix were continued and were administered as single 4 mL s.c. injections at 28 day intervals to the end of the trial. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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Testosterone levels were measured over time. The table below shows median levels at baseline (n=77 participants), 24 weeks (n=68), 36 weeks (n=59), 48 weeks (n=54), 72 weeks (n=9) |
| from baseline to week 72 |
| Turnhout |
| Belgium |
| Hopital Jean Minjoz | Besançon | France |
| Institut Bergonié | Bordeaux | France |
| Centre Francois Baclesse | Caen | France |
| CHU Henri Mondor | Créteil | France |
| Centre Oscar Lambret | Lille | France |
| Centre Leon Berard | Lyon | France |
| Hopital de la Timone | Marseille | France |
| CRLC Val d' Aurelle - Oncology Radiotherapy | Montpellier | France |
| Hôpital Saint Louis - Radiotherapy Departement | Paris | France |
| Hôpital Tenon | Paris | France |
| Clinique Francheville | Périgueux | France |
| CHU La Milétrie - Oncology Radiotherapy | Poitiers | France |
| Clinique Saint Brieuc | Saint-Brieuc | France |
| Centre de Lutte Contre le Cancer Nantes-Atlantique Centre René Gauducheau | Saint-Herblain | France |
| Institut de Cancérologie de la Loire | Saint-Priest-en-Jarez | France |
| Centre Paul Strauss | Strasbourg | France |
| Centre de radiologie Saint Louis | Toulon | France |
| Clinique du Parc | Toulouse | France |
| IGR | Villejuif | France |
| Azienda Ospedaliero Universitaria Ospedali riuniti | Ancona | Italy |
| Policlinico S.Orsola Malpighi - Universita' degli Studi di Bologna | Bologna | Italy |
| Clinica Urologica 1 Universita Firenze | Florence | Italy |
| Fondazione IRCCS Istituto Nazionale Tumori | Milan | Italy |
| Fondazione IRCCS Ospedale Maggiore Policlinico Mangiagalli e Regina Elena | Milan | Italy |
| Azienda Ospedaliera Universitaria Federico II | Naples | Italy |
| Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone dell'Universita' degli Studi di Palermo | Palermo | Italy |
| Clinica Urologica - Azienda Ospedaliera di Perugia | Perugia | Italy |
| Azienda Ospedaliera S. Andrea - Universita' la Sapienza di Roma | Roma | Italy |
| S.C. Di Urologia - IRCCS Ospedale Casa Sollievo della Sofferenza | San Giovanni Rotondo | Italy |
| Azienda Ospedaliero Universitaria S. Giovanni Battista - Molinette | Torino | Italy |
| Hospital Fernando da Fonseca | Amadora | Portugal |
| Hospitais Universidade Coimbra | Coimbra | Portugal |
| Centro Hospitalar Lisboa Norte, Hospital Santa Maria | Lisbon | Portugal |
| Hospital S.João | Porto | Portugal |
| Hospital Universitario Principe de Asturias | Alcalá de Henares-Madrid | Spain |
| Fundacion Hospital Alcorcón | Alcorcón | Spain |
| Fundación Puigvert | Barcelona | Spain |
| Hospital de la Santa Creu i Sant Pau | Barcelona | Spain |
| Hospital Universitari Vall d´Hebron | Barcelona | Spain |
| Hospital de Basurto | Bilbao | Spain |
| Hospital Clinico Universitario S. Carlos | Madrid | Spain |
| Hospital Doce de Octubre | Madrid | Spain |
| Hospital universitario Ramón y Cajal | Madrid | Spain |
| Hospital Universitario Puerta de Hierro | Majadahonda | Spain |
| Hospital Manacor | Manacor | Spain |
| Hospital Universitario Central de Asturias | Oviedo | Spain |
| Hospital Santiago de Compostela | Santiago de Compostela | Spain |
| Hospital Virgen Macarena | Seville | Spain |
| Fundación IVO | Valencia | Spain |
| Hospital Xeral de Vigo | Vigo | Spain |
| Investigational site | Gothenburg | Sweden |
| SU/Sahlgrenska | Gothenburg | Sweden |
| Helsingborgs Lasarett | Helsingborg | Sweden |
| Universitetssjukhuset MAS | Malmö | Sweden |
| Södertälje Sjukhus | Södertälje | Sweden |
| Uppsala/Akademiska sjukhuset | Uppsala | Sweden |
| Ankara University Faculty of Medicine - Sıhhıye | Ankara | Turkey (Türkiye) |
| Cerrahpasa Faculty of Medicine - Kocamustafapasa | Istanbul | Turkey (Türkiye) |
| Istanbul University Faculty of Medicine - ÇAPA | Istanbul | Turkey (Türkiye) |
| Marmara University Faculty of Medicine - Altunizade | Istanbul | Turkey (Türkiye) |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Degarelix | The degarelix doses were administered into the abdominal wall every 28 days. For patients treated with goserelin in the previous trials (CS28, CS30 and CS31),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 of 80 mg (20 mg/mL) degarelix were administered as single 4 mL s.c. injections at 28 day intervals from day 28 to the end of the trial. For patients treated with degarelix in the previous trials, maintenance doses of 80 mg (20 mg/mL) degarelix were continued and were administered as single 4 mL s.c. injections at 28 day intervals to the end of the trial. |
| 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 | Count of Participants | Participants |
| |||||||||||||||||||||||
| Region of Enrollment | Number | participants |
| |||||||||||||||||||||||
| Body Mass Index (BMI) | Mean | Standard Deviation | kilogram per square meter |
| ||||||||||||||||||||||
| 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 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 (7 participants). | Number | Participants |
|
| 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 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. | Posted | Number | Participants | Up to 22.5 months |
|
|
| |||||||||||||||||||||||||||||||||||||
| Primary | 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. | Posted | Number | Participants | Up to 22.5 months |
|
| ||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Serum Levels of Prostate Specific Antigen (PSA)Over Time | PSA levels were measured over time. The table below shows median levels at baseline (n=77 participants), 24 weeks (n=56), 36 weeks (n=58), 48 weeks (n=48), 72 weeks (n=9) | The table below shows median levels at baseline (n=77 participants), 24 weeks (n=56), 36 weeks (n=58), 48 weeks (n=48), 72 weeks (n=9) | Posted | Median | Full Range | ng/mL | from baseline to 72 weeks |
|
| ||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Serum Levels of Testosterone Over Time | Testosterone levels were measured over time. The table below shows median levels at baseline (n=77 participants), 24 weeks (n=68), 36 weeks (n=59), 48 weeks (n=54), 72 weeks (n=9) | The table below shows median levels at baseline (n=77 participants), 24 weeks (n=68), 36 weeks (n=59), 48 weeks (n=54), 72 weeks (n=9) | Posted | Median | Full Range | ng/mL | from baseline to week 72 |
|
|
Baseline to end of treatment (maximum exposure to degarelix is approximately 25 months)
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.
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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 | The degarelix doses were administered into the abdominal wall every 28 days. For patients treated with goserelin in the previous trials (CS28, CS30 and CS31),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 of 80 mg (20 mg/mL) degarelix were administered as single 4 mL s.c. injections at 28 day intervals from day 28 to the end of the trial. For patients treated with degarelix in the previous trials, maintenance doses of 80 mg (20 mg/mL) degarelix were continued and were administered as single 4 mL s.c. injections at 28 day intervals to the end of the trial. | 5 | 77 | 30 | 77 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Vitreous haemorrhage | Eye disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Chest pain | General disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
| |
| Convulsion | Nervous system disorders | MedDRA 12.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Haematochezia | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Rectal tenesmus | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Injection site inflammation | General disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Chills | General disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Injection site pain | General disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Chest pain | General disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
| |
| Viral upper respiratory tract | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
| |
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Prostate cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 12.0 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Hot flush | 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 |
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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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| Belgium |
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| Turkey |
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| Italy |
|
| Sweden |
|
| Gleason Score 7-10 |
|
|
| Metastatic |
|
| Not Classifiable |
|
| Title | Measurements |
|---|---|
|
| B-White blood cell count (10^9/L) >=16.0 |
|
| B-Red blood cell count (10^12/L) <=3.5 |
|
| B-Platelet count (10^9/L) <=75 |
|
| S-Aspartate aminotransferase (IU/L) >3xULN |
|
| S-Potassium (mmol/L) >=5.8 |
|
| S-Urea nitrogen (mmol/L) >=10.7 |
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