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| ID | Type | Description | Link |
|---|---|---|---|
| 2008-005232-33 | EudraCT Number |
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The purpose of this phase 3B trial was to see how well a new trial drug (degarelix) works in terms of reducing the size of the prostate volume in prostate cancer patients who were scheduled to undergo subsequent radiotherapy for treatment of their prostate cancer. Prior to receiving radiotherapy, it is recommended that patients with intermediate to high risk prostate cancer are pre-treated with hormone therapy (so-called neoadjuvant therapy) which is known to reduce the size of the prostate and thereby decrease the required radiation field and enable a more safe and effective treatment. In this trial, participants were randomly selected (like flipping a coin) to receive either degarelix given alone or a standard hormone therapy (combination of goserelin and bicalutamide. The treatment was given for three months and the prostate size was measured by ultra sound at the beginning and at the end of the trial. The participants were required to come to the clinic for 5 or 6 visits during the three months.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Degarelix 240 mg/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 second and third doses of 80 mg (20 mg/mL) degarelix were administered as single 4 mL s.c. injections on Days 28 and 56, respectively. |
|
| Goserelin (3.6 mg) + bicalutamide (50 mg) | Active Comparator | On Day 0, the participants began once-daily oral (p.o.) treatment with bicalutamide as anti-androgen flare protection. This treatment continued for 2 weeks after the first dose of goserelin (i.e. 17 days in total). On Day 3, the first goserelin implant was inserted s.c. into the abdominal wall. The second and third doses of goserelin were administered on Days 31 and 59, respectively. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Degarelix | 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 second and third doses of 80 mg (20 mg/mL) degarelix were administered as single 4 mL s.c. injections on Days 28 and 56, respectively. |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Prostate Size Based on Trans Rectal Ultra Sound (TRUS) at Week 12 (Full Analysis Set) | TRUS is a method of measuring the size of the prostate. | After treatment of 12 weeks compared to Baseline |
| Change From Baseline in Prostate Size Based on Trans Rectal Ultra Sound (TRUS) at Week 12 (Per Protocol Analysis Set) | TRUS is a method of measuring the size of the prostate. | After treatment of 12 weeks compared to Baseline |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Total International Prostate Symptom Score (IPSS) at Week 4, 8, and 12 | The IPSS is a tool commonly used to assess the severity of lower urinary tract symptoms (LUTS), and to monitor the progress of the disease once treatment has been initiated. The participant completes a questionnaire containing 7 questions regarding incomplete emptying, frequency, intermittency, urgency, weak stream, straining, and nocturia. Each question is assigned a score of 0-5. The total score is then classified according to the following scale: 0 to 7 = mildly symptomatic; 8 to 19 = moderately symptomatic; and 20 to 35 = severely symptomatic. |
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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 |
|---|---|---|---|---|---|---|
| Alabama Research Center | Birmingham | Alabama | 35209 | United States | ||
| Urology Centers of Alabama |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34350976 | Derived | Zengerling F, Jakob JJ, Schmidt S, Meerpohl JJ, Blumle A, Schmucker C, Mayer B, Kunath F. Degarelix for treating advanced hormone-sensitive prostate cancer. Cochrane Database Syst Rev. 2021 Aug 5;8(8):CD012548. doi: 10.1002/14651858.CD012548.pub2. | |
| 23257248 | Derived | Mason M, Maldonado Pijoan X, Steidle C, Guerif S, Wiegel T, van der Meulen E, Bergqvist PB, Khoo V. Neoadjuvant androgen deprivation therapy for prostate volume reduction, lower urinary tract symptom relief and quality of life improvement in men with intermediate- to high-risk prostate cancer: a randomised non-inferiority trial of degarelix versus goserelin plus bicalutamide. Clin Oncol (R Coll Radiol). 2013 Mar;25(3):190-6. doi: 10.1016/j.clon.2012.09.010. Epub 2012 Dec 17. |
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The participants were recruited by outpatient urologists, radiotherapists or oncologists. A total of 240 patients were to be randomised in a 3:1 ratio to one of two treatment groups (180 participants were to be treated with degarelix; 60 participants were to be treated with goserelin+bicalutamide). The recruitment period was April 2009 - June 2011.
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| ID | Title | Description |
|---|---|---|
| FG000 | Degarelix 240 mg/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 second and third doses of 80 mg (20 mg/mL) degarelix were administered as single 4 mL s.c. injections on Days 28 and 56, respectively. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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|
|
| Goserelin | Drug | Goserelin implants (3.6 mg) were inserted s.c. into the abdominal wall every 28 days. The first dose was administered on Day 3. The second and third doses of goserelin were administered on Days 31 and 59, respectively. |
|
|
| Bicalutamide | Drug | On Day 0, participants began once-daily per-oral (p.o.) treatment with bicalutamide (50 mg) as anti-androgen flare protection; this treatment continued for 14 days after the first dose of goserelin. |
|
|
| After treatment of 4, 8, and 12 weeks compared to Baseline |
| Change From Baseline in Serum Testosterone Levels During the Study | After treatment of 4, 8, and 12 weeks compared to Baseline |
| Change From Baseline in Serum Prostate-Specific Antigen (PSA) Levels During the Study | After treatment of 4, 8, and 12 weeks compared to Baseline |
| Change From Baseline in Serum Oestradiol Levels During the Study | After treatment of 4, 8, and 12 weeks compared to Baseline |
| Change From Baseline in Quality of Life (QoL) Related to Urinary Symptoms at Each Visit | The IPSS questionnaire included an additional single question to assess the participant's QoL in relation to his urinary symptoms. The question was: 'If you were to spend the rest of your life with your urinary condition the way it is now, how would you feel about that?' The possible answers to this question ranged from 'delighted' (a score of '0') to 'terrible' (a score of '6'). | After treatment of 4, 8, and 12 weeks compared to Baseline |
| 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. | Baseline to 12 weeks of treatment |
| Number of Participants With Markedly Abnormal Values in Safety Laboratory Variables | The figures present the number of participants who had abnormal (defined as above upper limit of normal range (ULN)) 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. | Baseline to 12 weeks of treatment |
| Homewood |
| Alabama |
| 35209 |
| United States |
| Alaska Urological Association | Anchorage | Alaska | 99508 | United States |
| Arizona Urologic Specialists | Tuscon | Arizona | 85712 | United States |
| Orange County Urology | Lagua Hills | California | 92653 | United States |
| Tri-Valley Urology Medical Group | Murrieta | California | 92563 | United States |
| Connecticut Clinical Research Center | Middlebury | Connecticut | 06762 | United States |
| South Florida Medical Research | Aventura | Florida | 33180 | United States |
| DCT -Celebration, LLC dba Discovery Clinical Trials | Celebration | Florida | 34747 | United States |
| Pinellas Urology Inc. | St. Petersburg | Florida | 33710 | United States |
| Palm Beach Urology Associates | Wellington | Florida | 33449 | United States |
| Summit Research Institute | Bloomington | Indiana | 47403 | United States |
| Northeast Indiana Research | Fort Wayne | Indiana | 46825 | United States |
| Urology Center Research Institute | Englewood | New Jersey | 07631 | United States |
| Urology Group of New Mexico | Albuquerque | New Mexico | 87109 | United States |
| Premier Medical Group of Hudson | Baldwinsville | New York | 12601 | United States |
| University Urology Associates | New York | New York | 10016 | United States |
| Urology Associates | Nashville | Tennessee | 37209 | United States |
| Urology of Virginia | Norfolk | Virginia | 23502 | United States |
| Hopital Jean Minjoz | Besançon | 25000 | France |
| Institut Bergonié | Bordeaux | 33076 | France |
| Centre Francois Baclesse | Caen | 14000 | France |
| CHU Henri Mondor | Créteil | 94000 | France |
| Centre Oscar Lambret | Lille | 59020 | France |
| Centre Leon Berard | Lyon | 69008 | France |
| Hopital de la Timone | Marseille | 13385 | France |
| CRLC Val d'Aurelle Oncology Radiotherapy | Montpellier | CX5 34298 | France |
| Hôpital Tenon | Paris | 75000 | France |
| Hôpital Saint Louis, Radiotherapy Departement | Paris | 75010 | France |
| Clinique Francheville | Périgueux | 24000 | France |
| CHU La Milétrie, Oncology Radiotherapy | Poitiers | 86000 | France |
| Clinique Saint Brieuc | Saint-Brieuc | 22015 | 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 | CX 42271 | France |
| Centre Paul Strauss | Strasbourg | 67085 | France |
| Centre de radiologie Saint Louis | Toulon | 83100 | France |
| Clinique du Parc | Toulouse | 31400 | France |
| IGR | Villejuif | 94805 | France |
| Charité-Universitätsmedizin, Campus Benjamin Franklin Klinik für Urologie | Berlin | D-12203 | Germany |
| Städtisches Klinikum Braunschweig | Braunschweig | D-38126 | Germany |
| Universitätsklinikum Dresden, Klinik und Poliklinik für Urologie | Dresden | D-01307 | Germany |
| Universitätsklinikum Ulm, Klinik für Strahlentherapie und Radioonkologie | Ulm | D-89081 | Germany |
| General University Hospital of Alexandroupolis | Alexandroupoli | 68100 | Greece |
| General Hospital of Athens, "Sismanogleio", University of Athens, Marouse | Athens | 15126 | Greece |
| University General Hospital of Loannina, Medical School | Loannina | 45110 | Greece |
| University General Hospital of Patras | Pátrai | 26504 | Greece |
| Albert Schweitzer Ziekenhuis, Ioc., Dordwijk | Dordrecht | 3318 AT | Netherlands |
| Groene Hart Ziekenhuis, urology | Gouda | 2803 HH | Netherlands |
| Franciscus Gasthuis, Dept. urology | Rotterdam | 3045 PM | Netherlands |
| Maastad Ziekenhuis, Ioc. Clara | Rotterdam | 3078HT | Netherlands |
| Vlietland Ziekenhuis, Dept. urology | Schiedam | 3118 JH | Netherlands |
| St. Elisabeth Ziekenhuis Tilburg | Tilburg | 5000 LC | Netherlands |
| Hospital de la Santa Creu i Sant Pau | Barcelona | 08025 | Spain |
| Hospital Universitari Vall d´Hebron | Barcelona | 08035 | Spain |
| Hospital Universitario La Paz | Madrid | 28046 | Spain |
| Fundación IVO | Valencia | 46009 | Spain |
| Kent Oncology Centre Maidstone Hospital | Maidstone | Kent | ME16 9QQ | United Kingdom |
| Mount Vernon Cancer Center | Northwood | Middlesex | HA6 2RN | United Kingdom |
| Oncology Royal United Hospital Bath NHS Trust | Bath | BA1 3NG | United Kingdom |
| Addenbrooke's Hospital, Oncology Centre | Cambridge | CB2 0QQ | United Kingdom |
| St. James' University Hospital | Leeds | LS9 7TF | United Kingdom |
| The Royal Marsden NHS, Foundation Trust | London | SW3 6JJ | United Kingdom |
| Charing Cross Hospital | London | W6 8FR | United Kingdom |
| Northern Centre for Cancer Treatment, Newcastle General Hospital | Newcastle upon Tyne | NE4 6BE | United Kingdom |
| Southhampton General Hospital, Cancer Care Directorate, Southhampton Oncology Centre | Southhampton | SO16 6YD | United Kingdom |
| Velindre Hospital, Cardiff University | Whitchurch | CF14 2TL | United Kingdom |
| FG001 |
| Goserelin (3.6 mg) + Bicalutamide (50 mg) |
On Day 0, the participants began once-daily oral (p.o.) treatment with bicalutamide as anti-androgen flare protection. This treatment continued for 2 weeks after the first dose of goserelin (i.e. 17 days in total). On Day 3, the first goserelin implant was inserted s.c. into the abdominal wall. The second and third doses of goserelin were administered on Days 31 and 59, respectively. |
| Full Analysis Set (FAS) |
|
| Per Protocol (PP) Analysis Set |
|
| Safety Analysis Set |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Degarelix 240 mg/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 second and third doses of 80 mg (20 mg/mL) degarelix were administered as single 4 mL s.c. injections on Days 28 and 56, respectively. |
| BG001 | Goserelin (3.6 mg) + Bicalutamide (50 mg) | On Day 0, the participants began once-daily oral (p.o.) treatment with bicalutamide as anti-androgen flare protection. This treatment continued for 2 weeks after the first dose of goserelin (i.e. 17 days in total). On Day 3, the first goserelin implant was inserted s.c. into the abdominal wall. The second and third doses of goserelin were administered on Days 31 and 59, respectively. |
| BG002 | 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 Continuous | Full analysis set (FAS). | Mean | Standard Deviation | years |
| ||||||||||||||
| Sex: Female, Male | FAS. | Count of Participants | Participants |
| |||||||||||||||
| Race (NIH/OMB) | FAS. | Count of Participants | Participants |
| |||||||||||||||
| Region of Enrollment | FAS. | Number | participants |
| |||||||||||||||
| Body Weight | FAS. | Mean | Standard Deviation | kilogram |
| ||||||||||||||
| Body Mass Index | FAS. | 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. | 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 (9 participants). | Number | participants |
| |||||||||||||||
| Serum Testosterone Levels | FAS. | Median | Full Range | nanograms per milliliter |
| ||||||||||||||
| Serum Prostate-Specific Antigen (PSA) Levels | FAS. | Median | Full Range | nanograms per millilter |
| ||||||||||||||
| Serum Oestradiol Levels | FAS. | Median | Full Range | nanograms per deciliter |
| ||||||||||||||
| Prostate Volume | FAS. Prostate volume was measured with a Trans Rectal Ultrasound Scan (TRUS). | Mean | Standard Deviation | milliliter |
| ||||||||||||||
| Total International Prostate Symptom Score (IPSS) | FAS. The IPSS is a tool commonly used to assess the severity of lower urinary tract symptoms (LUTS), and to monitor the progress of the disease once treatment has been initiated. The participant completes a questionnaire containing 7 questions regarding incomplete emptying, frequency, intermittency, urgency, weak stream, straining, and nocturia. Each question is assigned a score of 0-5. The total score is then classified according to the following scale: 0 to 7 = mildly symptomatic; 8 to 19 = moderately symptomatic; and 20 to 35 = severely symptomatic. | Mean | Standard Deviation | scores on a scale |
| ||||||||||||||
| Quality of Life (QoL) Related to Urinary Symptoms | FAS. The IPSS questionnaire included an additional single question to assess the participant's QoL in relation to his urinary symptoms. The question was: 'If you were to spend the rest of your life with your urinary condition the way it is now, how would you feel about that?' The possible answers to this question ranged from 'delighted' (a score of '0') to 'terrible' (a score of '6'). | Mean | Standard Deviation | scores on a scale |
|
| 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 | Change From Baseline in Prostate Size Based on Trans Rectal Ultra Sound (TRUS) at Week 12 (Full Analysis Set) | TRUS is a method of measuring the size of the prostate. | FAS, Observed Case (OC) i.e. only participants with a reported value were included in the analysis. | Posted | Mean | Standard Deviation | milliliter | After treatment of 12 weeks compared to Baseline |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Primary | Change From Baseline in Prostate Size Based on Trans Rectal Ultra Sound (TRUS) at Week 12 (Per Protocol Analysis Set) | TRUS is a method of measuring the size of the prostate. | FAS, OC. | Posted | Mean | Standard Deviation | milliliter | After treatment of 12 weeks compared to Baseline |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Total International Prostate Symptom Score (IPSS) at Week 4, 8, and 12 | The IPSS is a tool commonly used to assess the severity of lower urinary tract symptoms (LUTS), and to monitor the progress of the disease once treatment has been initiated. The participant completes a questionnaire containing 7 questions regarding incomplete emptying, frequency, intermittency, urgency, weak stream, straining, and nocturia. Each question is assigned a score of 0-5. The total score is then classified according to the following scale: 0 to 7 = mildly symptomatic; 8 to 19 = moderately symptomatic; and 20 to 35 = severely symptomatic. | FAS, OC. | Posted | Mean | Standard Deviation | scores on a scale | After treatment of 4, 8, and 12 weeks compared to Baseline |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Serum Testosterone Levels During the Study | FAS, OC. | Posted | Median | Full Range | nanograms per milliliter | After treatment of 4, 8, and 12 weeks compared to Baseline |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Serum Prostate-Specific Antigen (PSA) Levels During the Study | FAS, OC. | Posted | Median | Full Range | nanograms per milliliter | After treatment of 4, 8, and 12 weeks compared to Baseline |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Serum Oestradiol Levels During the Study | FAS, OC. | Posted | Median | Full Range | nanogram per deciliter | After treatment of 4, 8, and 12 weeks compared to Baseline |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Quality of Life (QoL) Related to Urinary Symptoms at Each Visit | The IPSS questionnaire included an additional single question to assess the participant's QoL in relation to his urinary symptoms. The question was: 'If you were to spend the rest of your life with your urinary condition the way it is now, how would you feel about that?' The possible answers to this question ranged from 'delighted' (a score of '0') to 'terrible' (a score of '6'). | FAS, OC. | Posted | Mean | Standard Deviation | scores on a scale | After treatment of 4, 8, and 12 weeks compared to Baseline |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 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 analysis set. | Posted | Number | participants | Baseline to 12 weeks of treatment |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Markedly Abnormal Values in Safety Laboratory Variables | The figures present the number of participants who had abnormal (defined as above upper limit of normal range (ULN)) 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 set. | Posted | Number | participants | Baseline to 12 weeks of treatment |
|
12 weeks.
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 mg/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 second and third doses of 80 mg (20 mg/mL) degarelix were administered as single 4 mL s.c. injections on Days 28 and 56, respectively. | 7 | 181 | 158 | 181 | ||
| EG001 | Goserelin (3.6 mg) + Bicalutamide (50 mg) | On Day 0, the participants began once-daily oral (p.o.) treatment with bicalutamide as anti-androgen flare protection. This treatment continued for 2 weeks after the first dose of goserelin (i.e. 17 days in total). On Day 3, the first goserelin implant was inserted s.c. into the abdominal wall. The second and third doses of goserelin were administered on Days 31 and 59, respectively. | 0 | 64 | 53 | 64 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Atrial fibrillation | Cardiac disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Retinal detachment | Eye disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA 12.0 | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA 12.0 | Systematic Assessment |
| |
| Blood alkaline phosphatase increased | Investigations | MedDRA 12.0 | Systematic Assessment |
| |
| Gamma-glutamyltransferase increased | Investigations | MedDRA 12.0 | Systematic Assessment |
| |
| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Gastric cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 12.0 | Systematic Assessment |
| |
| Lung neoplasm malignant | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 12.0 | Systematic Assessment |
| |
| Urinary retention | Renal and urinary disorders | MedDRA 12.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Injection site pain | General disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Injection site erythema | General disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Injection site pruritus | General disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Injection site swelling | General disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Libido decreased | Psychiatric disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Pollakiuria | Renal and urinary disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Erectile dysfunction | Reproductive system and breast 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 |
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 |
| D017273 | Goserelin |
| C053541 | bicalutamide |
| ID | Term |
|---|---|
| D007987 | Gonadotropin-Releasing Hormone |
| D010906 | Pituitary Hormone-Releasing Hormones |
| D007028 | Hypothalamic Hormones |
| D036361 | Peptide Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D009479 | Neuropeptides |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D009842 | Oligopeptides |
| D009419 | Nerve Tissue Proteins |
| D011506 | Proteins |
Not provided
Not provided
| Male |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| France |
|
| Greece |
|
| Spain |
|
| Netherlands |
|
| Germany |
|
| United Kingdom |
|
| Gleason Score 7 |
|
| Gleason Score 8-10 |
|
| Locally Advanced |
|
| Metastatic |
|
| Not Classifiable |
|
|
|
|
|
|
|
|
|
|
|
| Units | Counts |
|---|
| Participants |
|
|
| Units | Counts |
|---|---|
| Participants |
|
|