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Recruitment rate; a lower than anticipated observed cardiovascular event rate. The Sponsor decision to stop the trial was not based on any safety concerns or any knowledge of the results, or influenced by issues imposed by the COVID-19 pandemic.
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| Name | Class |
|---|---|
| Memorial Sloan Kettering Cancer Center | OTHER |
| Duke Clinical Research Institute | OTHER |
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The purpose of this trial is to test if a marketed drug for advanced prostate cancer (FIRMAGON) can reduce the risk of cardiovascular complications as compared to another marketed drug for advanced prostate cancer (LUPRON DEPOT) in subjects with prostate cancer and cardiovascular disease.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Degarelix | Experimental |
| |
| Leuprolide | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Degarelix | Drug |
|
| |
| Leuprolide |
| Measure | Description | Time Frame |
|---|---|---|
| Time From Randomization to the First Confirmed (Adjudicated) Occurrence of the Composite Major Adverse Cardiovascular Event (MACE) Endpoint; Percentage of Observed Subjects With Outcome Measure Events During the Trial | Composite MACE endpoint was defined as: death due to any cause, non-fatal myocardial infarction or non-fatal stroke. Kaplan Meier plots of the cumulative incidence rate by treatment groups were used to depict first confirmed (adjudicated) occurrence of composite MACE over time. Percentage of observed subjects with outcome measure events during the trial are reported. Subjects were censored at the time a subject discontinued the trial, was lost to follow-up, discontinued treatment with IMP, initiated treatment with prohibited medication (including hormonal combination therapy), or at Day 336, whichever occurred first. | Randomization to Day 336 (end-of-trial) |
| Measure | Description | Time Frame |
|---|---|---|
| Time From Randomization to the First Confirmed (Adjudicated) Occurrence of Cardiovascular (CV)-Related Death, Non-fatal Myocardial Infarction or Non-fatal Stroke; Percentage of Observed Subjects With Outcome Measure Events During the Trial | Kaplan Meier plots of the cumulative incidence rate by treatment groups were used to depict confirmed (adjudicated) occurrence of CV-related death, non-fatal myocardial infarction or non-fatal stroke. Percentage of observed subjects with outcome measure events during the trial are reported. Subjects were censored at the time a subject discontinued the trial, was lost to follow-up, discontinued treatment with IMP, initiated treatment with prohibited medication (including hormonal combination therapy), or at Day 336, whichever occurred first. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Global Clinical Compliance | Ferring Pharmaceuticals | Study Director |
| Susan Slovin, MD | Sidney Kimmel Center for Urologic and Prostate Cancers, Memorial Sloan Kettering Cancer Center | Principal Investigator |
| John Alexander, MD, MHS | Division of Cardiovascular Medicine, Duke Clinical Research Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Urology Center of Alabama PC | Birmingham | Alabama | 35209 | United States | ||
| Arizona Institute of Urology |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34459214 | Derived | Lopes RD, Higano CS, Slovin SF, Nelson AJ, Bigelow R, Sorensen PS, Melloni C, Goodman SG, Evans CP, Nilsson J, Bhatt DL, Clarke NW, Olesen TK, Doyle-Olsen BT, Kristensen H, Arney L, Roe MT, Alexander JH; PRONOUNCE Study Investigators. Cardiovascular Safety of Degarelix Versus Leuprolide in Patients With Prostate Cancer: The Primary Results of the PRONOUNCE Randomized Trial. Circulation. 2021 Oct 19;144(16):1295-1307. doi: 10.1161/CIRCULATIONAHA.121.056810. Epub 2021 Aug 30. | |
| 34396210 |
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In total, 702 subjects were screened of which 545 subjects were randomized. Of the randomized subjects, 544 subjects were exposed to the investigational medicinal product (IMP): 275 to Degarelix and 269 to Leuprolide. One subject was randomized in error and not exposed to IMP.
The trial was performed at 113 investigational sites in 12 countries between Apr 2016 to Mar 2021.
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| ID | Title | Description |
|---|---|---|
| FG000 | Degarelix 240 mg/80 mg | Degarelix 240 mg/80 mg: Degarelix at a starting dose of 240 mg administered as two subcutaneous (SC) depot injections, each containing 120 mg of degarelix; followed by up to 11 maintenance doses of 80 mg degarelix administered as single SC depot injections at monthly (28-day) intervals. |
| FG001 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Mar 26, 2021 | Mar 21, 2022 |
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| Drug |
|
|
| Randomization to Day 336 (end-of-trial) |
| Time From Randomization to Confirmed (Adjudicated) CV-related Death; Percentage of Observed Subjects With Outcome Measure Events During the Trial | Kaplan Meier plots of the cumulative incidence rate by treatment groups were used to depict confirmed (adjudicated) CV-related death. Percentage of observed subjects with outcome measure events during the trial are reported. Percentage of observed subjects with outcome measure events during the trial are reported. Subjects were censored at the time a subject discontinued the trial, was lost to follow-up, discontinued treatment with IMP, initiated treatment with prohibited medication (including hormonal combination therapy), or at Day 336, whichever occurred first. | Randomization to Day 336 (end-of-trial) |
| Time From Randomization to the First Confirmed (Adjudicated) Myocardial Infarction; Percentage of Observed Subjects With Outcome Measure Events During the Trial | Kaplan Meier plots of the cumulative incidence rate by treatment groups were used to depict first confirmed (adjudicated) myocardial infarction. Percentage of observed subjects with outcome measure events during the trial are reported. Subjects were censored at the time a subject discontinued the trial, was lost to follow-up, discontinued treatment with IMP, initiated treatment with prohibited medication (including hormonal combination therapy), or at Day 336, whichever occurred first. | Randomization to Day 336 (end-of-trial) |
| Time From Randomization to the First Confirmed (Adjudicated) Stroke; Percentage of Observed Subjects With Outcome Measure Events During the Trial | Kaplan Meier plots of the cumulative incidence rate by treatment groups were used to depict first confirmed (adjudicated) stroke. Percentage of observed subjects with outcome measure events during the trial are reported. Subjects were censored at the time a subject discontinued the trial, was lost to follow-up, discontinued treatment with IMP, initiated treatment with prohibited medication (including hormonal combination therapy), or at Day 336, whichever occurred first. | Randomization to Day 336 (end-of-trial) |
| Time From Randomization to the First Confirmed (Adjudicated) Unstable Angina Requiring Hospitalization; Percentage of Observed Subjects With Outcome Measure Events During the Trial | Kaplan Meier plots of the cumulative incidence rate by treatment groups were used to depict first confirmed (adjudicated) unstable angina requiring hospitalization. Percentage of observed subjects with outcome measure events during the trial are reported. Subjects were censored at the time a subject discontinued the trial, was lost to follow-up, discontinued treatment with IMP, initiated treatment with prohibited medication (including hormonal combination therapy), or at Day 336, whichever occurred first. | Randomization to Day 336 (end-of-trial) |
| Time From Randomization to Death Due to Any Cause; Percentage of Observed Subjects With Outcome Measure Events During the Trial | Kaplan Meier plots of the cumulative incidence rate by treatment groups were used to depict death due to any cause. Percentage of observed subjects with outcome measure events during the trial are reported. Subjects were censored at the time a subject discontinued the trial, was lost to follow-up, discontinued treatment with IMP, initiated treatment with prohibited medication (including hormonal combination therapy), or at Day 336, whichever occurred first. | Randomization to Day 336 (end-of-trial) |
| Testosterone Levels at Days 28, 168 and 336 in the Degarelix and Leuprolide Treatment Groups | Median levels and interquartile ranges for serum testosterone at Days 28, 168, and 336 are presented. | Days 28, 168 and 336 (end-of-trial) |
| Time From Randomization to Failure in Progression-free Survival (PFS); Percentage of Observed Subjects With Outcome Measure Events During the Trial | Time to failure in PFS was defined as the time, measured in days, from randomization to the first occurrence of either death, radiographic disease progression, introduction of additional prostate cancer therapies for progression, or PSA failure. Subjects who discontinued treatment with IMP or withdrew from the trial were censored at the time of discontinuation/withdrawal. Kaplan Meier plots of the cumulative incidence rate by treatment groups were used to depict failure in PFS. Percentage of observed subjects with outcome measure events during the trial are reported. | From randomization to end-of-trial for each subject (subjects not censored at Day 336) |
| Changes From Baseline in International Prostate Symptom Score (IPSS) Total and Quality of Life (QoL) Scores | Lower urinary tract symptoms were measured with the IPSS Version 1 (IPSS-1). The IPSS is a subject-administered questionnaire containing seven items to evaluate symptoms of urinary obstruction (incomplete emptying, frequency, intermittency, urgency, weak stream, straining, nocturia) over the preceding week. Each urinary symptom question was assigned points from 0 to 5 indicating increasing severity of the particular symptom. The total IPSS-1 score was then calculated as summation over the responses for all 7 questions. The total IPSS-1 score was transformed to a scale from 0 (lowest score) to 100 (highest score). Higher scores reflect higher severity of symptoms. The IPSS-1 included an additional single question to assess a subject's QoL in relation to his urinary symptoms; response to this question was analyzed separately and was not included in the total IPSS score. The score was similarly scaled from 0 to 100. Change from baseline in IPSS Total and QoL scores are presented. | Baseline to Days 168 and 336 (end-of-trial) |
| Total Number of CV-related Hospitalization Events Over the Duration of the Trial | The total number of CV-related hospitalizations over the duration of the trial was defined as the number of hospitalizations due to CV-related adverse events, observed from the first exposure to IMP up until Day 336 for each subject. | First dose of IMP to Day 336 (end-of-trial) |
| Total Number of Coronary Artery By-pass Grafting (CABG) or Percutaneous Coronary Intervention (PCI) Procedures Over the Duration of the Trial | The total number of CABG or PCI procedures observed for each subject over the duration of the trial | First dose of IMP to Day 336 (end-of-trial) |
| Total Number of CV-related Emergency Room (ER) Visit Events Over the Duration of the Trial | CV-related ER visit events (that did not lead to hospitalization) was observed from the first exposure to IMP up until Day 336 for each subject. | First dose of IMP to Day 336 (end-of-trial) |
| Change in Utility, Based on EuroQol Group 5 Dimensions 5 Levels Questionnaire (EQ-5D-5L) | The EQ-5D-5L essentially consists of 2 systems - the EQ-5D-5L descriptive system and the EQ visual analogue scale (EQ VAS). The EQ-5D-5L descriptive system comprises the following 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. The EQ VAS is an overall estimation of the present health status. The results from the EQ-5D-5L questionnaire were converted into quality adjusted life year (QALY) units. The QALY is estimated by combining the value of life (utility value) and length of life. Quality adjusted life years are based on a principle assuming that a year of life lived in perfect health is worth 1 QALY and that a year of life lived in a state of less than perfect health is worth less than 1. | Baseline to Day 336 (end-of-trial) |
| Changes From Baseline in Duke Activity Status Index (DASI) Global Score | The DASI is a self-administered instrument developed to measure functional capacity in subjects with cardiovascular disease (CVD). It contains 12 items referring to the present time, assessing the ability to perform physical tasks in five domains: personal care (1 item), ambulation (4 items), household tasks (4 items), sexual function (1 item) and recreation (2 items). Each question was answered by one of four options: 'yes with no difficulty' / 'yes, but with some difficulty' / 'no, I can't do this' / 'don't do this for other reasons'. A global score was calculated with a higher score indicating a higher functional capacity. The minimum score is 0 and the maximum score is 58.2 points. Change from baseline in DASI Global score is presented. | Baseline to Days 168 and 336 (end-of-trial) |
| Changes From Baseline in Cardiac Anxiety Questionnaire (CAQ) Global Score and Score Per Domain | The CAQ is a self-administered questionnaire developed to measure heart-focused anxiety in persons with or without heart disease. It contains 18 items referring to the present time assessing cardiac anxiety in three domains: fear (8 items, each item could be scored between 0 "never" to 4 "always", maximum total score 32), avoidance (5 items, each item could be scored between 0 "never" to 4 "always", maximum total score 20) and attention (5 items, each item could be scored between 0 "never" to 4 "always", maximum total score 20). A higher score indicated greater cardiac anxiety and the total score range was between 0 and 72. Change from baseline in CAQ Global score and score per domain are presented. | Baseline to Days 168 and 336 (end-of-trial) |
| Number of Subjects With Adverse Events (AEs) | Adverse events were recorded from signed informed consent until end-of-trial. Adverse events with onset after start of IMP treatment, and within 3 months after (1 month=28 days) last dosing of IMP, were considered 'treatment-emergent' and are presented for the safety analysis set. | Start of IMP treatment until 3 months after last dosing of IMP |
| Intensity of AEs | The intensity of AE was graded using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) (version 4.02) 5-point scale. AE were categorized as grade 1 Mild (minor; no specific medical intervention; asymptomatic laboratory findings only; marginal clinical relevance), Grade 2 Moderate (minimal intervention: local intervention; non-invasive intervention), Grade 3 Severe (significant symptoms, requiring hospitalization or invasive intervention; transfusion; elective interventional radiological procedure; therapeutic endoscopy or operation), Grade 4 Life-threatening or disabling (complicated by acute, life-threatening metabolic or CV complications such as circulatory failure, hemorrhage, sepsis. Life-threatening physiologic consequences; need for intensive care or emergent invasive procedure; emergent interventional radiological procedure, therapeutic endoscopy or operation) and Grade 5 Death. Events with grades 3, 4 and 5 were categorized as severe. | Start of IMP treatment until 3 months after last dosing of IMP |
| Changes in Vital Signs | Number of subjects shifting from normal value(s) in vital signs (pulse and blood pressure) at baseline to clinically significant abnormal value(s) at end-of-trial are presented. Note: Only subjects with appropriate baseline and post-baseline data are included in the evaluation. | Baseline to Day 336 (end-of-trial) |
| Tucson |
| Arizona |
| 85704 |
| United States |
| Urological Associates of Southern Arizona | Tucson | Arizona | 85715 | United States |
| University of Arizona College of Medicine | Tucson | Arizona | 85724 | United States |
| Urology Associates, PA | Little Rock | Arkansas | 72211 | United States |
| Pacific Cancer Medical Center, Inc. | Anaheim | California | 92801 | United States |
| San Diego Clinical Trials | La Mesa | California | 91942 | United States |
| Clinical Trials Research | Lincoln | California | 95648 | United States |
| VA Greater Los Angeles Healthcare System | Los Angeles | California | 90073 | United States |
| University of California, Irvine Medical Center | Orange | California | 92868 | United States |
| Skyline Urology | Torrance | California | 90505 | United States |
| Innovative Clinical Research Institute | Whittier | California | 90603 | United States |
| Urology Center of Colorado | Denver | Colorado | 80211 | United States |
| Yale University | New Haven | Connecticut | 06519 | United States |
| Urologic Surgeons of Washington | Washington D.C. | District of Columbia | 20036 | United States |
| San Marcus Research Clinic Inc | Miami | Florida | 33014 | United States |
| Mount Sinai Comprehensive Cancer Center | Miami Beach | Florida | 33140 | United States |
| Clinical Research Center of Florida | Pompano Beach | Florida | 33060 | United States |
| Florida Urology Partners | Tampa | Florida | 33615 | United States |
| Comprehensive Urologic Care | Lake Barrington | Illinois | 60010 | United States |
| Springfield Clinic LLP | Springfield | Illinois | 62703 | United States |
| Urology of Indiana LLC | Greenwood | Indiana | 46032 | United States |
| First Urology PSC | Jeffersonville | Indiana | 47130 | United States |
| Iowa Clinic | West Des Moines | Iowa | 50266 | United States |
| University of Kansas Medical Center Research Institute, Inc. | Kansas City | Kansas | 66160 | United States |
| Kansas City Urology Care | Lenexa | Kansas | 66214 | United States |
| Regional Urology, LLC | Shreveport | Louisiana | 71106 | United States |
| Chesapeake Urology Associates, P.A. | Towson | Maryland | 21204 | United States |
| Delaware Valley Urology LLC Westhampton | Mount Laurel | New Jersey | 08054 | United States |
| Holy Name Medical Center | Teaneck | New Jersey | 07666 | United States |
| Urology Group of New Mexico PC | Albuquerque | New Mexico | 87109 | United States |
| Advanced Urology Centers of New York Elmont Division | Elmont | New York | 11003 | United States |
| SUNY Upstate Medical University | Syracuse | New York | 13210 | United States |
| Montefiore Medical Center PRIME | The Bronx | New York | 10461 | United States |
| Duke University Medical Center | Durham | North Carolina | 27710 | United States |
| Veterans Affairs Medical Center-Salisbury, NC | Salisbury | North Carolina | 28144 | United States |
| Signal Point Clinical Research Center | Dayton | Ohio | 45409 | United States |
| Clinical Research Solutions PC | Middleburg Heights | Ohio | 44130 | United States |
| Urologic Consultants of Southeaster PA LLP | Bala-Cynwyd | Pennsylvania | 19004 | United States |
| Lancaster Urology | Lancaster | Pennsylvania | 17604 | United States |
| University of Pennsylvania | Philadelphia | Pennsylvania | 19104 | United States |
| Ralph H. Johnson VA Medical Center | Charleston | South Carolina | 29401 | United States |
| Medical University of South Carolina (MUSC) | Charleston | South Carolina | 29425 | United States |
| Erlanger Health System | Chattanooga | Tennessee | 37403 | United States |
| Urology of Virginia | Norfolk | Virginia | 23462 | United States |
| Seattle Urology Research Center | Burien | Washington | 98166 | United States |
| University of Washington School of Medicine | Seattle | Washington | 98195 | United States |
| Medical College of Wisconsin, Inc. | Milwaukee | Wisconsin | 53226 | United States |
| The Male Health Centre Euroscope Inc | Barrie | Ontario | Canada |
| J. Giddens Medicine Professional Corporation | Brampton | Ontario | Canada |
| G. Kenneth Jansz Medicine Professional Corporation | Burlington | Ontario | Canada |
| Urology Associates Urologic Medical Research | Kitchener | Ontario | Canada |
| London Health Sciences Centre | London | Ontario | Canada |
| Femalemale Health Centres | Oakville | Ontario | Canada |
| Princess Margaret Cancer Centre | Toronto | Ontario | Canada |
| Uro Laval | Laval | Quebec | Canada |
| Jewish General Hospital / McGill University | Montreal | Quebec | Canada |
| CHU de Québec -Hôtel-Dieu de Québec | Québec | Canada |
| Fakultni nemocnice Olomouc | Olomouc | Czechia |
| Fakultni nemocnice Ostrava | Ostrava | Czechia |
| Multiscan s.r.o. | Pardubice | Czechia |
| Urocentrum Plzen | Pilsen | Czechia |
| Fakultni nemocnice v Motole | Prague | Czechia |
| Proton Therapy Center Czech s.r.o. | Prague | Czechia |
| Oblastni nemocnice Pribram a.s. | Příbram | Czechia |
| Krajska zdravotni a.s. - Masarykova nemocnice v Usti nad Labem o.z. | Ústí nad Labem | Czechia |
| Keski-Suomen keskussairaala | Jyväskylä | Finland |
| Tampereen yliopistollinen | Tampere | Finland |
| Institut Sainte Catherine | Avignon | France |
| Groupe Hospitalier Pellegrin Tripode | Bordeaux | France |
| Hôpital Henri Mondor | Créteil | France |
| CHU de Grenoble - Hôpital Albert Michallon | Grenoble | France |
| CH de Libourne- Hopital Robert Boulin | Libourne | France |
| Hopital Claude Huriez - CHU Lille | Lille | France |
| Hopital Edouard Herriot - CHU Lyon | Lyon | France |
| Centre Hospitalier Régional Universitaire de Tours | Nantes | France |
| Hopital Bichat - Claude Bernard | Paris | France |
| Clinique Saint Jean Languedoc | Toulouse | France |
| Universitaetsklinikum Freiburg | Freiburg im Breisgau | Baden-Wurttemberg | Germany |
| Urologische Gemeinschaftspraxis | Kirchheim unter Teck | Baden-Wurttemberg | Germany |
| Urologische Gemeinschaftspraxis | Herzogenaurach | Bavaria | Germany |
| Staedtisches Klinikum Braunschweig GmbH - Standort Salzdahlumer | Braunschweig | Lower Saxony | Germany |
| Klinikum Oldenburg gGmbH | Oldenburg | Lower Saxony | Germany |
| Kliniken Maria Hilf GmbH | Mönchengladbach | North Rhine-Westphalia | Germany |
| Praxisklinik Urologie Rhein Ruhr | Mülheim | North Rhine-Westphalia | Germany |
| Staedtisches Klinikum Dresden Standort Dresden-Friedrichstadt | Dresden | Saxony | Germany |
| Urologie am Nordplatz | Leipzig | Saxony | Germany |
| Facharztpraxis für Urologie | Eisleben Lutherstadt | Saxony-Anhalt | Germany |
| Krankenhaus Martha-Maria Halle-Doelau | Halle | Saxony-Anhalt | Germany |
| Gynaekologisches Zentrum Bonn-Friedensplatz | Bonn | Germany |
| Central Clinic of Athens | Athens | Greece |
| General Hospital of Athens "Alexandra" | Athens | Greece |
| T.Y.P.E.T. Hygeias Melathron Hospital | Athens | Greece |
| University General Hospital of Heraklion | Heraklion | Greece |
| University of Patras Medical School | Pátrai | Greece |
| General Hospital Papageorgiou | Thessaloniki | Greece |
| Swietokrzyskie Centrum Onkologii | Kielce | Poland |
| DERMED Centrum Medyczne Sp. z o.o. | Lodz | Poland |
| Provita Profamilia | Piotrkow Trybunalski | Poland |
| WroMedica | Wroclaw | Poland |
| City Clinical Hospital n.a. Botkin | Moscow | Russia |
| FSBI "Moscow scientific research oncology institute" | Moscow | Russia |
| FSBSI "Russian Oncological Scientific Center n.a. N.N. Blokhin" | Moscow | Russia |
| SBEI HPE "Moscow State Medical and Dentistry University n.a. A. I. Evdokimov" | Moscow | Russia |
| FBHI Privolzhskiy District Medical Centre FMBA of Russia | Nizhny Novgorod | Russia |
| Medical Center Avitsenna | Novosibirsk | Russia |
| BHI of Omsk region "Clinical Oncology Dispensary | Omsk | Russia |
| FFSBI "The Nikiforov Russian Center of Emergency and Radiation Medicine" | Saint Petersburg | Russia |
| SBHI of Sverdiovsk Region "Sverdiovsk Regional Clinical Hospital #1 | Yekaterinburg | Russia |
| CUIMED s.r.o. | Bratislava | Slovakia |
| Urocentrum Bratislava s.r.o. | Bratislava | Slovakia |
| Nemocnica Kosice-Saca, a.s. | Košice | Slovakia |
| Vychodoslovensky onkologicky ustav, a.s. | Košice | Slovakia |
| Zeleznicna nemocnica Kosice | Košice | Slovakia |
| UROCENTRUM LEVICE s.r.o. | Levice | Slovakia |
| UROAMB s.r.o. | Liptovský Mikuláš | Slovakia |
| Univerzitna nemocnica Martin | Martin | Slovakia |
| Fakultna nemocnica Nitra | Nitra | Slovakia |
| UROEXAM, spol. s r.o. | Nitra | Slovakia |
| MILAB s.r.o. | Prešov | Slovakia |
| MIRAMED s.r.o | Rimavská Sobota | Slovakia |
| UROCENTRUM SALA s.r.o. | Šaľa | Slovakia |
| Privatna Urologicka ambulancia | Trenčín | Slovakia |
| Fakultna nemocnica s poliklinikou Zilina | Žilina | Slovakia |
| Groote Schuur Hospital Department of Urology | Cape Town | Western Cape | South Africa |
| Prince Philip Hospital | Llanelli | Carmarthenshire | United Kingdom |
| Charing Cross Hospital | London | Greater London | United Kingdom |
| Scunthorpe General Hospital | Scunthorpe | Lincolnshire | United Kingdom |
| St Peter's Hospital | Chertsey | Surrey | United Kingdom |
| Royal Hallamshire Hospital | Sheffield | West Midlands | United Kingdom |
| Addenbrooke's Hospital | Cambridge | United Kingdom |
| Royal Devon and Exeter Hospital (Wonford) | Exeter | United Kingdom |
| Salford Royal | Salford | United Kingdom |
| Derived |
| Melloni C, Slovin SF, Blemings A, Goodman SG, Evans CP, Nilsson J, Bhatt DL, Zubovskiy K, Olesen TK, Dugi K, Clarke NW, Higano CS, Roe MT; PRONOUNCE Investigators. Cardiovascular Safety of Degarelix Versus Leuprolide for Advanced Prostate Cancer: The PRONOUNCE Trial Study Design. JACC CardioOncol. 2020 Mar 17;2(1):70-81. doi: 10.1016/j.jaccao.2020.01.004. eCollection 2020 Mar. |
| 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. |
| Leuprolide 22.5 mg |
Leuprolide 22.5 mg: Leuprolide at dose of 22.5 mg administered as intramuscular depot injection every 3 months throughout the trial. |
| Full Analysis Set (FAS) |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
The FAS consisted of all randomized and treated subjects (who received at least one dose of IMP) and was analyzed based on the planned (randomized) treatment.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Degarelix 240 mg/80 mg | Degarelix 240 mg/80 mg: Degarelix at a starting dose of 240 mg administered as two SC depot injections, each containing 120 mg of degarelix; followed by up to 11 maintenance doses of 80 mg degarelix administered as single SC depot injections at monthly (28-day) intervals. |
| BG001 | Leuprolide 22.5 mg | Leuprolide 22.5 mg: Leuprolide at dose of 22.5 mg administered as intramuscular depot injection every 3 months throughout the trial. |
| 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 | Mean | Standard Deviation | years |
| |||||||||||||||
| Age, Customized | Count of Participants | Participants | No |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants | No |
| |||||||||||||||
| Ethnicity (NIH/OMB) | Number analyzed differs from the overall population as baseline ethnicity was not reported for some of the subjects. | Count of Participants | Participants | No |
| ||||||||||||||
| Race (NIH/OMB) | Number analyzed differs from the overall population as baseline race was not reported for some of the subjects. | Count of Participants | Participants | No |
| ||||||||||||||
| Region of Enrollment | Number | participants |
| ||||||||||||||||
| Baseline body mass index (BMI) | Number analyzed differs from the overall population as baseline BMI was not reported for some of the subjects. | Mean | Standard Deviation | kg/m^2 |
| ||||||||||||||
| Stage of prostate cancer | Count of Participants | Participants | No |
| |||||||||||||||
| Eastern Cooperative Oncology Group (ECOG) performance score | The ECOG performance status was assessed according to a scale from 0 to 4, where 0 is fully active, able to carry on all pre-disease performance without restriction and where 4 is completely disabled. Cannot carry on any self-care. Totally confined to bed or chair. | Count of Participants | Participants | No |
| ||||||||||||||
| Testosterone levels | Number analyzed differs from the overall population as baseline testosterone was not reported for some of the subjects. | Mean | Standard Deviation | ng/dL |
| ||||||||||||||
| Prostate Specific Antigen (PSA) | Number analyzed differs from the overall population as baseline PSA was not reported for some of the subjects. | Mean | Standard Deviation | 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 | Time From Randomization to the First Confirmed (Adjudicated) Occurrence of the Composite Major Adverse Cardiovascular Event (MACE) Endpoint; Percentage of Observed Subjects With Outcome Measure Events During the Trial | Composite MACE endpoint was defined as: death due to any cause, non-fatal myocardial infarction or non-fatal stroke. Kaplan Meier plots of the cumulative incidence rate by treatment groups were used to depict first confirmed (adjudicated) occurrence of composite MACE over time. Percentage of observed subjects with outcome measure events during the trial are reported. Subjects were censored at the time a subject discontinued the trial, was lost to follow-up, discontinued treatment with IMP, initiated treatment with prohibited medication (including hormonal combination therapy), or at Day 336, whichever occurred first. | The FAS consisted of all randomized and treated subjects (who received at least one dose of IMP) and was analyzed based on the planned (randomized) treatment. | Posted | Number | percentage of subjects | Randomization to Day 336 (end-of-trial) |
|
|
|
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| Secondary | Time From Randomization to the First Confirmed (Adjudicated) Occurrence of Cardiovascular (CV)-Related Death, Non-fatal Myocardial Infarction or Non-fatal Stroke; Percentage of Observed Subjects With Outcome Measure Events During the Trial | Kaplan Meier plots of the cumulative incidence rate by treatment groups were used to depict confirmed (adjudicated) occurrence of CV-related death, non-fatal myocardial infarction or non-fatal stroke. Percentage of observed subjects with outcome measure events during the trial are reported. Subjects were censored at the time a subject discontinued the trial, was lost to follow-up, discontinued treatment with IMP, initiated treatment with prohibited medication (including hormonal combination therapy), or at Day 336, whichever occurred first. | The FAS consisted of all randomized and treated subjects (who received at least one dose of IMP) and was analyzed based on the planned (randomized) treatment. | Posted | Number | percentage of subjects | Randomization to Day 336 (end-of-trial) |
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| Secondary | Time From Randomization to Confirmed (Adjudicated) CV-related Death; Percentage of Observed Subjects With Outcome Measure Events During the Trial | Kaplan Meier plots of the cumulative incidence rate by treatment groups were used to depict confirmed (adjudicated) CV-related death. Percentage of observed subjects with outcome measure events during the trial are reported. Percentage of observed subjects with outcome measure events during the trial are reported. Subjects were censored at the time a subject discontinued the trial, was lost to follow-up, discontinued treatment with IMP, initiated treatment with prohibited medication (including hormonal combination therapy), or at Day 336, whichever occurred first. | The FAS consisted of all randomized and treated subjects (who received at least one dose of IMP) and was analyzed based on the planned (randomized) treatment. | Posted | Number | percentage of subjects | Randomization to Day 336 (end-of-trial) |
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| Secondary | Time From Randomization to the First Confirmed (Adjudicated) Myocardial Infarction; Percentage of Observed Subjects With Outcome Measure Events During the Trial | Kaplan Meier plots of the cumulative incidence rate by treatment groups were used to depict first confirmed (adjudicated) myocardial infarction. Percentage of observed subjects with outcome measure events during the trial are reported. Subjects were censored at the time a subject discontinued the trial, was lost to follow-up, discontinued treatment with IMP, initiated treatment with prohibited medication (including hormonal combination therapy), or at Day 336, whichever occurred first. | The FAS consisted of all randomized and treated subjects (who received at least one dose of IMP) and was analyzed based on the planned (randomized) treatment. | Posted | Number | percentage of subjects | Randomization to Day 336 (end-of-trial) |
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| Secondary | Time From Randomization to the First Confirmed (Adjudicated) Stroke; Percentage of Observed Subjects With Outcome Measure Events During the Trial | Kaplan Meier plots of the cumulative incidence rate by treatment groups were used to depict first confirmed (adjudicated) stroke. Percentage of observed subjects with outcome measure events during the trial are reported. Subjects were censored at the time a subject discontinued the trial, was lost to follow-up, discontinued treatment with IMP, initiated treatment with prohibited medication (including hormonal combination therapy), or at Day 336, whichever occurred first. | The FAS consisted of all randomized and treated subjects (who received at least one dose of IMP) and was analyzed based on the planned (randomized) treatment. | Posted | Number | percentage of subjects | Randomization to Day 336 (end-of-trial) |
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| Secondary | Time From Randomization to the First Confirmed (Adjudicated) Unstable Angina Requiring Hospitalization; Percentage of Observed Subjects With Outcome Measure Events During the Trial | Kaplan Meier plots of the cumulative incidence rate by treatment groups were used to depict first confirmed (adjudicated) unstable angina requiring hospitalization. Percentage of observed subjects with outcome measure events during the trial are reported. Subjects were censored at the time a subject discontinued the trial, was lost to follow-up, discontinued treatment with IMP, initiated treatment with prohibited medication (including hormonal combination therapy), or at Day 336, whichever occurred first. | The FAS consisted of all randomized and treated subjects (who received at least one dose of IMP) and was analyzed based on the planned (randomized) treatment. | Posted | Number | percentage of subjects | Randomization to Day 336 (end-of-trial) |
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| Secondary | Time From Randomization to Death Due to Any Cause; Percentage of Observed Subjects With Outcome Measure Events During the Trial | Kaplan Meier plots of the cumulative incidence rate by treatment groups were used to depict death due to any cause. Percentage of observed subjects with outcome measure events during the trial are reported. Subjects were censored at the time a subject discontinued the trial, was lost to follow-up, discontinued treatment with IMP, initiated treatment with prohibited medication (including hormonal combination therapy), or at Day 336, whichever occurred first. | The FAS consisted of all randomized and treated subjects (who received at least one dose of IMP) and was analyzed based on the planned (randomized) treatment. | Posted | Number | percentage of subjects | Randomization to Day 336 (end-of-trial) |
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| Secondary | Testosterone Levels at Days 28, 168 and 336 in the Degarelix and Leuprolide Treatment Groups | Median levels and interquartile ranges for serum testosterone at Days 28, 168, and 336 are presented. | The FAS consisted of all randomized and treated subjects (who received at least one dose of IMP) and was analyzed based on the planned (randomized) treatment. Subjects analyzed for this endpoint represent subjects who were evaluable for this outcome measure. | Posted | Median | Inter-Quartile Range | ng/dL | Days 28, 168 and 336 (end-of-trial) |
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| Secondary | Time From Randomization to Failure in Progression-free Survival (PFS); Percentage of Observed Subjects With Outcome Measure Events During the Trial | Time to failure in PFS was defined as the time, measured in days, from randomization to the first occurrence of either death, radiographic disease progression, introduction of additional prostate cancer therapies for progression, or PSA failure. Subjects who discontinued treatment with IMP or withdrew from the trial were censored at the time of discontinuation/withdrawal. Kaplan Meier plots of the cumulative incidence rate by treatment groups were used to depict failure in PFS. Percentage of observed subjects with outcome measure events during the trial are reported. | The FAS consisted of all randomized and treated subjects (who received at least one dose of IMP) and was analyzed based on the planned (randomized) treatment. | Posted | Number | percentage of subjects | From randomization to end-of-trial for each subject (subjects not censored at Day 336) |
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| Secondary | Changes From Baseline in International Prostate Symptom Score (IPSS) Total and Quality of Life (QoL) Scores | Lower urinary tract symptoms were measured with the IPSS Version 1 (IPSS-1). The IPSS is a subject-administered questionnaire containing seven items to evaluate symptoms of urinary obstruction (incomplete emptying, frequency, intermittency, urgency, weak stream, straining, nocturia) over the preceding week. Each urinary symptom question was assigned points from 0 to 5 indicating increasing severity of the particular symptom. The total IPSS-1 score was then calculated as summation over the responses for all 7 questions. The total IPSS-1 score was transformed to a scale from 0 (lowest score) to 100 (highest score). Higher scores reflect higher severity of symptoms. The IPSS-1 included an additional single question to assess a subject's QoL in relation to his urinary symptoms; response to this question was analyzed separately and was not included in the total IPSS score. The score was similarly scaled from 0 to 100. Change from baseline in IPSS Total and QoL scores are presented. | The FAS consisted of all randomized and treated subjects (who received at least one dose of IMP) and was analyzed based on the planned (randomized) treatment. Subjects analyzed for this endpoint represent subjects who were evaluable for this outcome measure. | Posted | Least Squares Mean | 95% Confidence Interval | score on a scale | Baseline to Days 168 and 336 (end-of-trial) |
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| Secondary | Total Number of CV-related Hospitalization Events Over the Duration of the Trial | The total number of CV-related hospitalizations over the duration of the trial was defined as the number of hospitalizations due to CV-related adverse events, observed from the first exposure to IMP up until Day 336 for each subject. | Posted | Number | Events | First dose of IMP to Day 336 (end-of-trial) |
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| Secondary | Total Number of Coronary Artery By-pass Grafting (CABG) or Percutaneous Coronary Intervention (PCI) Procedures Over the Duration of the Trial | The total number of CABG or PCI procedures observed for each subject over the duration of the trial | Posted | Number | Events | First dose of IMP to Day 336 (end-of-trial) |
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| Secondary | Total Number of CV-related Emergency Room (ER) Visit Events Over the Duration of the Trial | CV-related ER visit events (that did not lead to hospitalization) was observed from the first exposure to IMP up until Day 336 for each subject. | Posted | Number | Events | First dose of IMP to Day 336 (end-of-trial) |
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| Secondary | Change in Utility, Based on EuroQol Group 5 Dimensions 5 Levels Questionnaire (EQ-5D-5L) | The EQ-5D-5L essentially consists of 2 systems - the EQ-5D-5L descriptive system and the EQ visual analogue scale (EQ VAS). The EQ-5D-5L descriptive system comprises the following 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. The EQ VAS is an overall estimation of the present health status. The results from the EQ-5D-5L questionnaire were converted into quality adjusted life year (QALY) units. The QALY is estimated by combining the value of life (utility value) and length of life. Quality adjusted life years are based on a principle assuming that a year of life lived in perfect health is worth 1 QALY and that a year of life lived in a state of less than perfect health is worth less than 1. | The FAS consisted of all randomized and treated subjects (who received at least one dose of IMP) and was analyzed based on the planned (randomized) treatment. Subjects analyzed for this endpoint represent subjects who were evaluable for this outcome measure. | Posted | Least Squares Mean | 95% Confidence Interval | QALY | Baseline to Day 336 (end-of-trial) |
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| Secondary | Changes From Baseline in Duke Activity Status Index (DASI) Global Score | The DASI is a self-administered instrument developed to measure functional capacity in subjects with cardiovascular disease (CVD). It contains 12 items referring to the present time, assessing the ability to perform physical tasks in five domains: personal care (1 item), ambulation (4 items), household tasks (4 items), sexual function (1 item) and recreation (2 items). Each question was answered by one of four options: 'yes with no difficulty' / 'yes, but with some difficulty' / 'no, I can't do this' / 'don't do this for other reasons'. A global score was calculated with a higher score indicating a higher functional capacity. The minimum score is 0 and the maximum score is 58.2 points. Change from baseline in DASI Global score is presented. | The FAS consisted of all randomized and treated subjects (who received at least one dose of IMP) and was analyzed based on the planned (randomized) treatment. Subjects analyzed for this endpoint represent subjects who were evaluable for this outcome measure. | Posted | Least Squares Mean | 95% Confidence Interval | score on a scale | Baseline to Days 168 and 336 (end-of-trial) |
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| Secondary | Changes From Baseline in Cardiac Anxiety Questionnaire (CAQ) Global Score and Score Per Domain | The CAQ is a self-administered questionnaire developed to measure heart-focused anxiety in persons with or without heart disease. It contains 18 items referring to the present time assessing cardiac anxiety in three domains: fear (8 items, each item could be scored between 0 "never" to 4 "always", maximum total score 32), avoidance (5 items, each item could be scored between 0 "never" to 4 "always", maximum total score 20) and attention (5 items, each item could be scored between 0 "never" to 4 "always", maximum total score 20). A higher score indicated greater cardiac anxiety and the total score range was between 0 and 72. Change from baseline in CAQ Global score and score per domain are presented. | The FAS consisted of all randomized and treated subjects (who received at least one dose of IMP) and was analyzed based on the planned (randomized) treatment. Subjects analyzed for this endpoint represent subjects who were evaluable for this outcome measure. | Posted | Least Squares Mean | 95% Confidence Interval | score on a scale | Baseline to Days 168 and 336 (end-of-trial) |
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| Secondary | Number of Subjects With Adverse Events (AEs) | Adverse events were recorded from signed informed consent until end-of-trial. Adverse events with onset after start of IMP treatment, and within 3 months after (1 month=28 days) last dosing of IMP, were considered 'treatment-emergent' and are presented for the safety analysis set. | The safety analysis set consisted of all treated subjects (who received at least one dose of IMP) and was analyzed based on the actual treatment received. | Posted | Number | subjects | Start of IMP treatment until 3 months after last dosing of IMP |
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| Secondary | Intensity of AEs | The intensity of AE was graded using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) (version 4.02) 5-point scale. AE were categorized as grade 1 Mild (minor; no specific medical intervention; asymptomatic laboratory findings only; marginal clinical relevance), Grade 2 Moderate (minimal intervention: local intervention; non-invasive intervention), Grade 3 Severe (significant symptoms, requiring hospitalization or invasive intervention; transfusion; elective interventional radiological procedure; therapeutic endoscopy or operation), Grade 4 Life-threatening or disabling (complicated by acute, life-threatening metabolic or CV complications such as circulatory failure, hemorrhage, sepsis. Life-threatening physiologic consequences; need for intensive care or emergent invasive procedure; emergent interventional radiological procedure, therapeutic endoscopy or operation) and Grade 5 Death. Events with grades 3, 4 and 5 were categorized as severe. | The safety analysis set consisted of all treated subjects (who received at least one dose of IMP) and was analyzed based on the actual treatment received. | Posted | Number | subjects | Start of IMP treatment until 3 months after last dosing of IMP |
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| Secondary | Changes in Vital Signs | Number of subjects shifting from normal value(s) in vital signs (pulse and blood pressure) at baseline to clinically significant abnormal value(s) at end-of-trial are presented. Note: Only subjects with appropriate baseline and post-baseline data are included in the evaluation. | The safety analysis set consisted of all treated subjects (who received at least one dose of IMP) and was analyzed based on the actual treatment received. Subjects analyzed for this endpoint represent subjects who were evaluable for this outcome measure. | Posted | Count of Participants | Participants | No | Baseline to Day 336 (end-of-trial) |
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|
Start of IMP treatment until 3 months after last dosing of IMP
Adverse events were recorded from signing of the informed consent until end-of-trial. Events with onset after start of IMP treatment, and within 3 months after (1 month=28 days) last dosing of IMP, were considered 'treatment-emergent' and are presented for the safety analysis set (defined above). Non-fatal serious adverse events (SAEs) of myocardial infarction, stroke, and unstable angina constituted exceptions to the SAE reporting (6 events in the degarelix group, 10 in the leuprolide group).
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 | Degarelix 240 mg/80 mg: Degarelix at a starting dose of 240 mg administered as two SC depot injections, each containing 120 mg of degarelix; followed by up to 11 maintenance doses of 80 mg degarelix administered as single SC depot injections at monthly (28-day) intervals. | 11 | 275 | 47 | 275 | 250 | 275 |
| EG001 | Leuprolide 22.5 mg | Leuprolide 22.5 mg: Leuprolide at dose of 22.5 mg administered as intramuscular depot injection every 3 months throughout the trial. | 9 | 269 | 44 | 269 | 228 | 269 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cardiac failure chronic | Cardiac disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Cardiac failure | Cardiac disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Atrial flutter | Cardiac disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Atrioventricular block complete | Cardiac disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Bradycardia | Cardiac disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Acute myocardial infarction | Cardiac disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Angina pectoris | Cardiac disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Arrhythmia | Cardiac disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Ischaemic cardiomyopathy | Cardiac disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Sinus node dysfunction | Cardiac disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Supraventricular tachycardia | Cardiac disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Tachyarrhythmia | Cardiac disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Ventricular fibrillation | Cardiac disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Gastric ulcer haemorrhage | Gastrointestinal disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Haematochezia | Gastrointestinal disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Ileus | Gastrointestinal disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Inguinal hernia | Gastrointestinal disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Intestinal obstruction | Gastrointestinal disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Rectal haemorrhage | Gastrointestinal disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Umbilical hernia | Gastrointestinal disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Death | General disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Malaise | General disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Injection site swelling | General disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Non-cardiac chest pain | General disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Cholecystitis | Hepatobiliary disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Hepatic failure | Hepatobiliary disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA (24.0) | Systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA (24.0) | Systematic Assessment |
| |
| COVID-19 pneumonia | Infections and infestations | MedDRA (24.0) | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA (24.0) | Systematic Assessment |
| |
| Bacteraemia | Infections and infestations | MedDRA (24.0) | Systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA (24.0) | Systematic Assessment |
| |
| Cystitis | Infections and infestations | MedDRA (24.0) | Systematic Assessment |
| |
| Diverticulitis intestinal haemorrhagic | Infections and infestations | MedDRA (24.0) | Systematic Assessment |
| |
| Enterococcal sepsis | Infections and infestations | MedDRA (24.0) | Systematic Assessment |
| |
| Intervertebral discitis | Infections and infestations | MedDRA (24.0) | Systematic Assessment |
| |
| Osteomyelitis | Infections and infestations | MedDRA (24.0) | Systematic Assessment |
| |
| Pyelonephritis | Infections and infestations | MedDRA (24.0) | Systematic Assessment |
| |
| Respiratory tract infection | Infections and infestations | MedDRA (24.0) | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA (24.0) | Systematic Assessment |
| |
| Anastomotic ulcer haemorrhage | Injury, poisoning and procedural complications | MedDRA (24.0) | Systematic Assessment |
| |
| Cervical vertebral fracture | Injury, poisoning and procedural complications | MedDRA (24.0) | Systematic Assessment |
| |
| Femoral neck fracture | Injury, poisoning and procedural complications | MedDRA (24.0) | Systematic Assessment |
| |
| Femur fracture | Injury, poisoning and procedural complications | MedDRA (24.0) | Systematic Assessment |
| |
| Hip fracture | Injury, poisoning and procedural complications | MedDRA (24.0) | Systematic Assessment |
| |
| Lumbar vertebral fracture | Injury, poisoning and procedural complications | MedDRA (24.0) | Systematic Assessment |
| |
| Rib fracture | Injury, poisoning and procedural complications | MedDRA (24.0) | Systematic Assessment |
| |
| Skin laceration | Injury, poisoning and procedural complications | MedDRA (24.0) | Systematic Assessment |
| |
| Spinal compression fracture | Injury, poisoning and procedural complications | MedDRA (24.0) | Systematic Assessment |
| |
| Subdural haematoma | Injury, poisoning and procedural complications | MedDRA (24.0) | Systematic Assessment |
| |
| Upper limb fracture | Injury, poisoning and procedural complications | MedDRA (24.0) | Systematic Assessment |
| |
| Heart rate irregular | Investigations | MedDRA (24.0) | Systematic Assessment |
| |
| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Failure to thrive | Metabolism and nutrition disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Hypocalcaemia | Metabolism and nutrition disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Bone pain | Musculoskeletal and connective tissue disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Rhabdomyolysis | Musculoskeletal and connective tissue disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Brain neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (24.0) | Systematic Assessment |
| |
| Hodgkin's disease | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (24.0) | Systematic Assessment |
| |
| Pancreatic carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (24.0) | Systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Cerebrovascular accident | Nervous system disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Cerebral haemorrhage | Nervous system disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Cognitive disorder | Nervous system disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Sciatica | Nervous system disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Toxic encephalopathy | Nervous system disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Tremor | Nervous system disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Suicidal ideation | Psychiatric disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Completed suicide | Psychiatric disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Acute kidney injury | Renal and urinary disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Urinary retention | Renal and urinary disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Nephrolithiasis | Renal and urinary disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Renal failure | Renal and urinary disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Urinary tract obstruction | Renal and urinary disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Prostatitis | Reproductive system and breast disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Acute respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Acute respiratory distress syndrome | Respiratory, thoracic and mediastinal disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Pulmonary oedema | Respiratory, thoracic and mediastinal disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Deep vein thrombosis | Vascular disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Hypovolaemic shock | Vascular disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Peripheral artery thrombosis | Vascular disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Peripheral ischaemia | Vascular disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Thrombosis | Vascular disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Hepatic echinococciasis | Infections and infestations | MedDRA (24.0) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhoea | Gastrointestinal disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Injection site pain | General disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Injection site erythema | General disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Injection site swelling | General disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Injection site induration | General disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA (24.0) | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Pollakiuria | Renal and urinary disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Dysuria | Renal and urinary disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Haematuria | Renal and urinary disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Nocturia | Renal and urinary disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Hot flush | Vascular disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA (24.0) | Systematic Assessment |
|
The trial was terminated prematurely due to a slower than anticipated recruitment rate and a lower than anticipated observed CV event rate. Approximately 900 patients were planned to be included, however, at the time of stopping screening and recruitment 216 patients had completed the trial, 292 were ongoing, and 37 were withdrawn. The Sponsor decision to stop the trial was not based on any safety concerns, any knowledge of the results, or influenced by issues imposed by the COVID-19 pandemic.
A Publications Committee, including the signatory investigators, other Steering Committee members, and Sponsor representatives was established to function as an independent body of scientific and medical experts acting to facilitate, encourage, and coordinate the complete and accurate presentation and publication of the trial results. Members of the Publication Committee are responsible for review and approval of all abstracts and manuscripts based on the trial results.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Global Clinical Compliance | Ferring Pharmaceuticals | DK0-Disclosure@ferring.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Feb 24, 2021 | Mar 21, 2022 | SAP_001.pdf |
| 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 |
| D016729 | Leuprolide |
| 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
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| >= 75 years |
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| Canada |
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| United States |
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| Czechia |
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| Finland |
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| Poland |
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| South Africa |
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| United Kingdom |
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| Slovakia |
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| France |
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| Germany |
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| Russia |
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| Locally Advanced |
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| Metastatic |
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| Not classifiable |
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| 1 score |
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| 2 score |
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| Units | Counts |
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| Participants |
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| Participants |
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| Units | Counts |
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| Participants |
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| OG001 | Leuprolide 22.5 mg | Leuprolide 22.5 mg: Leuprolide at dose of 22.5 mg administered as intramuscular depot injection every 3 months throughout the trial. |
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Leuprolide 22.5 mg: Leuprolide at dose of 22.5 mg administered as intramuscular depot injection every 3 months throughout the trial. |
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Leuprolide 22.5 mg: Leuprolide at dose of 22.5 mg administered as intramuscular depot injection every 3 months throughout the trial. |
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Leuprolide 22.5 mg: Leuprolide at dose of 22.5 mg administered as intramuscular depot injection every 3 months throughout the trial. |
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| Leuprolide 22.5 mg |
Leuprolide 22.5 mg: Leuprolide at dose of 22.5 mg administered as intramuscular depot injection every 3 months throughout the trial. |
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| Participants |
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