Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2007-000323-17 | EudraCT Number |
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Company decision to discontinue the study, not due to any safety or efficacy concerns
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The primary objective was to evaluate and compare the efficacy of androgen deprivation with or without docetaxel as determined by the median progression free survival (PFS) over the period of 18-month therapy and at least 18-month follow-up.
The secondary objectives were:
The duration of the study per participant was to be at least 36 months, of which the treatment period was 18 months for all participants, followed by at least 18 months follow-up period.
Participants received study treatment for up to 18 months from the time of study therapy initiation or less if one of the following occurred: disease progression, unacceptable toxicity, death, participant refusal or treatment delay beyond the time frame that is permitted for each treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Docetaxel+Leuprolide+Bicalutamide | Experimental | Participants received docetaxel 75 milligram per square meter (mg/m^2) intravenous infusion over 1 hour every 3 weeks up to 10 cycles (3 week cycle) along with leuprolide 22.5 mg injection subcutaneously every 12 weeks up to 18 months and bicalutamide 50 mg tablet orally once daily for first 4 weeks of treatment. |
|
| Leuprolide+Bicalutamide | Active Comparator | Participants received leuprolide 22.5 mg injection subcutaneously every 12 weeks up to 18 months and bicalutamide 50 mg tablet orally once daily for first 4 weeks of treatment. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Docetaxel | Drug | 75 mg/m^2 intravenous infusion over 1 hour every 3 weeks up to 10 cycles. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Median Progression-Free Survival (PFS) in Intent-to-treat (ITT) Population | PFS was the time from randomization to the date of first documented prostate specific antigen (PSA) progression, or radiographic progression, or death due to prostate cancer in the absence of previous documentation of disease progression, whichever occurred first. PSA progression was determined as: a) During treatment period: a 50 percent (%) increase from baseline, which was confirmed by a second value; b) During follow-up: detectable PSA (defined as PSA greater than or equal to 0.05 nanogram per millimeter [ng/mL]), which was confirmed by consecutive observation (not less than 2 weeks apart). Median PFS was estimated using the Kaplan-Meier method. | Randomization until PSA progression or radiographic progression or death due to prostate cancer, assessed up to Month 60 |
| Progression-Free Survival (PFS) Rate at Month 36 in ITT Population | PFS rate at Month 36 was defined as probability of being progression-free at Month 36. PFS rate was estimated using the Kaplan-Meier method. | Month 36 |
| Median Progression-Free Survival (PFS) in Testosterone Specific Evaluable Population | PFS was the time from randomization to the date of first documented PSA progression, or radiographic progression, or death due to prostate cancer in the absence of previous documentation of disease progression, whichever occurred first. Median PFS was estimated using the Kaplan-Meier method. | Randomization until PSA progression or radiographic progression or death due to prostate cancer, assessed up to Month 60 |
| Progression-Free Survival (PFS) Rate at Month 36 in Testosterone Specific Evaluable Population | PFS rate at Month 36 was defined as probability of being progression-free at Month 36. PFS rate was estimated using the Kaplan-Meier method. | Month 36 |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival (OS): Number of Participants Who Died (All Cause) | The OS was the time interval from the date of randomization to the date of death due to any cause. OS was to be analyzed using the Kaplan-Meier method. However, the analysis was not performed due to insufficient number of events. Reported is the number of participants who died from any cause. | Randomization until death due to any cause, assessed up to Month 60 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Treatment-Emergent Adverse Events (TEAEs) | TEAE: any adverse event (AE) that occurred or worsened during the on-treatment period, which was the period from first administration of study treatment until 30 days after last administration of study treatment. AE: any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Serious AE: an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly, or medically important. Drug-related AEs were any untoward medical occurrences attributed to study drug in a participant who received study drug. National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 3.0 Grade 3 (severe) and Grade 4 (life threatening/disabling) TEAEs were also reported. |
Inclusion Criteria:
Diagnosis of prostate adenocarcinoma pathologically confirmed
History of radical prostatectomy (pre-operative radiation therapy to the prostate or pelvis or salvage radiation after radical prostatectomy was allowed)
Demonstration of biochemical progression of disease based on prostate specific antigen (PSA) doubling time. The minimum PSA value for eligibility was greater than or equal to (>=) 1. PSA doubling time over three values must be equal to (=) 9 months with a minimum of 3 weeks between assessments
Serum testosterone >=100 nanogram per deciliter (ng/dL)
Karnofsky performance status (KPS) >=70 percent (%)
Adequate organ function as defined by the following laboratory criteria:
Previous hormonal therapy was allowed provided that the total duration of therapy did not exceed 6 months
Man of childbearing potential who was willing to consent to use effective contraception while on treatment and for at least 3 months thereafter
Participant who was willing and was able to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures
Exclusion Criteria:
The above information was not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.
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| Name | Affiliation | Role |
|---|---|---|
| Barrett Childs, MD | Sanofi | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sanofi-Aventis Administrative Office | Bridgewater | New Jersey | 08807 | United States | ||
| Sanofi-Aventis Administrative Office |
Not provided
Participants were enrolled from 53 sites in North America (the United States of America and Canada) and Europe. Study was terminated after all participants had completed treatment with docetaxel, but before all participants had completed 18 months follow-up. The termination was not due to any safety or efficacy concerns.
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| ID | Title | Description |
|---|---|---|
| FG000 | Docetaxel+Leuprolide+Bicalutamide | Participants received docetaxel 75 milligram per square meter (mg/m^2) intravenous infusion over 1 hour every 3 weeks up to 10 cycles (3 week cycle) along with leuprolide 22.5 mg injection subcutaneously every 12 weeks up to 18 months and bicalutamide 50 mg tablet orally once daily for first 4 weeks of treatment. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
Not provided
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Not provided
| Leuprolide | Drug | 22.5 mg injection subcutaneously every 12 weeks up to 18 months. |
|
|
| Bicalutamide | Drug | 50 mg tablet orally once daily for first 4 weeks of treatment. |
|
| Cancer-Specific Survival: Number of Participants Who Died (Cancer-Specific) | The cancer-specific survival was the time from the date of randomization to the date of death due to prostate cancer. Cancer-specific survival was to be analyzed using the Kaplan-Meier method. However, the analysis was not performed due to insufficient number of events. Reported is the number of participants who died from prostate cancer. | Randomization until death due to prostate cancer, assessed up to Month 60 |
| Change From Baseline in Functional Assessment of Cancer Therapy-Prostate (FACT-P) Total Score at End of Treatment (EOT) | FACT-P is a 39-item participant questionnaire which assesses physical well-being (7 items), social/family well-being (7 items), emotional well-being (6 items), functional well-being (7 items), and additional prostate cancer specific concerns (12 items). All items are scored from 0 (not at all) to 4 (very much). The total FACT-P score ranges from 0-156, with higher scores representing a better quality of life with fewer symptoms. A score of 156 represents the best outcome. | Baseline, EOT (up to Month 18) |
| Change From Baseline in Functional Assessment of Cancer Therapy-Prostate (FACT-P) Trial Outcome Index (TOI) Score at EOT | Physical well-being, functional well-being, and prostate cancer concerns sub-scales of the FACT-P questionnaire were combined to calculate TOI. Total TOI score ranges from 0 to 104, with higher scores representing a better quality of life with fewer symptoms. | Baseline, EOT (up to Month 18) |
| Change From Baseline in Multidimensional Assessment of Fatigue (MAF) Index Score at EOT | MAF scale consists of 16-items to measure 4 dimensions of fatigue during past week: severity (Item 1-2), distress (Item 3), degree of interference in activities of daily living (Item 4-14), and timing (Item 15-16). Item 1-14 are scored on a numeric rating scale from 1 to 10, where higher score indicate more severity/distress/interference. Item 15-16 had multiple choice responses (4 responses each). Scale Index was calculated using Item 1-15, in following steps: 1) Item 15 score converted to 1-10 scale by multiplying the score with 2.5; 2) Average score was calculated from Item 4-14; 3) Finally scale index was calculated by adding Items 1, 2, 3 scores with average score from step 2 and converted score of Item 15 from step 1. Total MAF scale index score ranges 1 (no fatigue) to 50 (severe fatigue). | Baseline, EOT (up to Month 18) |
| Change From Baseline in Erectile Function Domain of International Index of Erectile Function (EF-IIEF) Total Score at EOT | EF-IIEF is a 6-item erectile function domain of IIEF. It consists of Question 1, 2, 3, 4, 5, and 15 of IIEF questionnaire. 5 questions are scored from 0 (no activity) to 5 (very high activity) and 1 question is scored from 1 (very low activity) to 5 (very high activity). Total EF-IIEF score ranges from 1 to 30, where higher score indicates high activity. | Baseline, EOT (up to Month 18) |
| From first administration of study treatment until 30 days after the last administration of study treatment |
| Diegem |
| Belgium |
| Sanofi-Aventis Administrative Office | Laval | Canada |
| Sanofi-Aventis Administrative Office | Prague | Czechia |
| Sanofi-Aventis Administrative Office | Frankfurt | Germany |
| Sanofi-Aventis Administrative Office | Vilnius | Lithuania |
| Sanofi-Aventis Administrative Office | Warsaw | Poland |
| Sanofi-Aventis Administrative Office | Bratislava | Slovakia |
| Sanofi-Aventis Administrative Office | Barcelona | Spain |
| FG001 |
| Leuprolide+Bicalutamide |
Participants received leuprolide 22.5 mg injection subcutaneously every 12 weeks up to 18 months and bicalutamide 50 mg tablet orally once daily for first 4 weeks of treatment. |
| Treated |
|
| Completed Study Treatment |
|
| Testosterone-Specific Evaluable |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
Safety population included all randomized participants who received at least part of one dose of any of the study drugs.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Docetaxel+Leuprolide+Bicalutamide | Participants received docetaxel 75 milligram per square meter (mg/m^2) intravenous infusion over 1 hour every 3 weeks up to 10 cycles (3 week cycle) along with leuprolide 22.5 mg injection subcutaneously every 12 weeks up to 18 months and bicalutamide 50 mg tablet orally once daily for first 4 weeks of treatment. |
| BG001 | Leuprolide+Bicalutamide | Participants received leuprolide 22.5 mg injection subcutaneously every 12 weeks up to 18 months and bicalutamide 50 mg tablet orally once daily for first 4 weeks of treatment. |
| 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 | Number | participants |
| ||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race/Ethnicity, Customized | Number | participants |
| ||||||||||||||||
| Body Surface Area (BSA) | BSA was calculated using the Dubois and Dubois formula: BSA (in square meter) = (weight^0.425* height^0.725)*0.007184; where weight is in kilogram (kg) and height is in centimeter (cm). Here "N" (number of participants analyzed) = 192, 198 for each treatment arm, respectively. | Mean | Standard Deviation | square meter (m^2) |
| ||||||||||||||
| Prior Radiation Therapy | Number | participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Median Progression-Free Survival (PFS) in Intent-to-treat (ITT) Population | PFS was the time from randomization to the date of first documented prostate specific antigen (PSA) progression, or radiographic progression, or death due to prostate cancer in the absence of previous documentation of disease progression, whichever occurred first. PSA progression was determined as: a) During treatment period: a 50 percent (%) increase from baseline, which was confirmed by a second value; b) During follow-up: detectable PSA (defined as PSA greater than or equal to 0.05 nanogram per millimeter [ng/mL]), which was confirmed by consecutive observation (not less than 2 weeks apart). Median PFS was estimated using the Kaplan-Meier method. | ITT population included all participants who were randomized, with study drug assignment designated according to randomization, regardless of whether participants received any study drug or a different drug from that to which they were randomized. | Posted | Median | 95% Confidence Interval | months | Randomization until PSA progression or radiographic progression or death due to prostate cancer, assessed up to Month 60 |
|
|
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Primary | Progression-Free Survival (PFS) Rate at Month 36 in ITT Population | PFS rate at Month 36 was defined as probability of being progression-free at Month 36. PFS rate was estimated using the Kaplan-Meier method. | ITT population. | Posted | Number | 95% Confidence Interval | percent chance of being progression-free | Month 36 |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Overall Survival (OS): Number of Participants Who Died (All Cause) | The OS was the time interval from the date of randomization to the date of death due to any cause. OS was to be analyzed using the Kaplan-Meier method. However, the analysis was not performed due to insufficient number of events. Reported is the number of participants who died from any cause. | ITT population. | Posted | Number | participants | Randomization until death due to any cause, assessed up to Month 60 |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Cancer-Specific Survival: Number of Participants Who Died (Cancer-Specific) | The cancer-specific survival was the time from the date of randomization to the date of death due to prostate cancer. Cancer-specific survival was to be analyzed using the Kaplan-Meier method. However, the analysis was not performed due to insufficient number of events. Reported is the number of participants who died from prostate cancer. | ITT population. | Posted | Number | participants | Randomization until death due to prostate cancer, assessed up to Month 60 |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Functional Assessment of Cancer Therapy-Prostate (FACT-P) Total Score at End of Treatment (EOT) | FACT-P is a 39-item participant questionnaire which assesses physical well-being (7 items), social/family well-being (7 items), emotional well-being (6 items), functional well-being (7 items), and additional prostate cancer specific concerns (12 items). All items are scored from 0 (not at all) to 4 (very much). The total FACT-P score ranges from 0-156, with higher scores representing a better quality of life with fewer symptoms. A score of 156 represents the best outcome. | ITT population. Here "N" (number of participants analyzed) signifies participants who were evaluable for this measure and "n" signifies participants evaluable at each time-point for each treatment arm, respectively. | Posted | Mean | Standard Deviation | units on a scale | Baseline, EOT (up to Month 18) |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Functional Assessment of Cancer Therapy-Prostate (FACT-P) Trial Outcome Index (TOI) Score at EOT | Physical well-being, functional well-being, and prostate cancer concerns sub-scales of the FACT-P questionnaire were combined to calculate TOI. Total TOI score ranges from 0 to 104, with higher scores representing a better quality of life with fewer symptoms. | ITT population. Here "N" (number of participants analyzed) signifies participants who were evaluable for this measure and "n" signifies participants evaluable at each time-point for each treatment arm, respectively. | Posted | Mean | Standard Deviation | units on a scale | Baseline, EOT (up to Month 18) |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Primary | Median Progression-Free Survival (PFS) in Testosterone Specific Evaluable Population | PFS was the time from randomization to the date of first documented PSA progression, or radiographic progression, or death due to prostate cancer in the absence of previous documentation of disease progression, whichever occurred first. Median PFS was estimated using the Kaplan-Meier method. | Testosterone-specific evaluable population included all participants who recovered testosterone to non-castrate levels (50 ng/mL) following the completion of treatment of leuprolide with at least 1 follow-up PSA assessment. | Posted | Median | 95% Confidence Interval | months | Randomization until PSA progression or radiographic progression or death due to prostate cancer, assessed up to Month 60 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Multidimensional Assessment of Fatigue (MAF) Index Score at EOT | MAF scale consists of 16-items to measure 4 dimensions of fatigue during past week: severity (Item 1-2), distress (Item 3), degree of interference in activities of daily living (Item 4-14), and timing (Item 15-16). Item 1-14 are scored on a numeric rating scale from 1 to 10, where higher score indicate more severity/distress/interference. Item 15-16 had multiple choice responses (4 responses each). Scale Index was calculated using Item 1-15, in following steps: 1) Item 15 score converted to 1-10 scale by multiplying the score with 2.5; 2) Average score was calculated from Item 4-14; 3) Finally scale index was calculated by adding Items 1, 2, 3 scores with average score from step 2 and converted score of Item 15 from step 1. Total MAF scale index score ranges 1 (no fatigue) to 50 (severe fatigue). | ITT population. Here "N" (number of participants analyzed) signifies participants who were evaluable for this measure and "n" signifies participants evaluable at each time-point for each treatment arm, respectively. | Posted | Mean | Standard Deviation | units on a scale | Baseline, EOT (up to Month 18) |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Primary | Progression-Free Survival (PFS) Rate at Month 36 in Testosterone Specific Evaluable Population | PFS rate at Month 36 was defined as probability of being progression-free at Month 36. PFS rate was estimated using the Kaplan-Meier method. | Testosterone-specific evaluable population included all participants who recovered testosterone to non-castrate levels (50 ng/mL) following completion of treatment of leuprolide with at least 1 follow-up PSA assessment. | Posted | Number | 95% Confidence Interval | percent chance of being progression-free | Month 36 |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Erectile Function Domain of International Index of Erectile Function (EF-IIEF) Total Score at EOT | EF-IIEF is a 6-item erectile function domain of IIEF. It consists of Question 1, 2, 3, 4, 5, and 15 of IIEF questionnaire. 5 questions are scored from 0 (no activity) to 5 (very high activity) and 1 question is scored from 1 (very low activity) to 5 (very high activity). Total EF-IIEF score ranges from 1 to 30, where higher score indicates high activity. | ITT population. Here "N" (number of participants analyzed) signifies participants who were evaluable for this measure and "n" signifies participants evaluable at each time-point for each treatment arm, respectively. | Posted | Mean | Standard Deviation | units on a scale | Baseline, EOT (up to Month 18) |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) | TEAE: any adverse event (AE) that occurred or worsened during the on-treatment period, which was the period from first administration of study treatment until 30 days after last administration of study treatment. AE: any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Serious AE: an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly, or medically important. Drug-related AEs were any untoward medical occurrences attributed to study drug in a participant who received study drug. National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 3.0 Grade 3 (severe) and Grade 4 (life threatening/disabling) TEAEs were also reported. | Safety population included all randomized participants who received at least part of one dose of any of the study drugs. | Posted | Number | participants | From first administration of study treatment until 30 days after the last administration of study treatment |
|
From signature of the informed consent form up to the last visit in the study
The analysis was performed on safety population, defined as all randomized participants who received at least part of one dose of any of the study drugs, and included all TEAEs that developed or worsened from first administration of study treatment until 30 days after last administration of study treatment.
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 | Docetaxel+Leuprolide+Bicalutamide | Participants received docetaxel 75 milligram per square meter (mg/m^2) intravenous infusion over 1 hour every 3 weeks up to 10 cycles (3 week cycle) along with leuprolide 22.5 mg injection subcutaneously every 12 weeks up to 18 months and bicalutamide 50 mg tablet orally once daily for first 4 weeks of treatment. | 49 | 196 | 185 | 196 | ||
| EG001 | Leuprolide+Bicalutamide | Participants received leuprolide 22.5 mg injection subcutaneously every 12 weeks up to 18 months and bicalutamide 50 mg tablet orally once daily for first 4 weeks of treatment. | 20 | 204 | 139 | 204 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| FEBRILE NEUTROPENIA | Blood and lymphatic system disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| NEUTROPENIA | Blood and lymphatic system disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| ANAEMIA | Blood and lymphatic system disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| LYMPHADENOPATHY | Blood and lymphatic system disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| ATRIAL FIBRILLATION | Cardiac disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| ACUTE MYOCARDIAL INFARCTION | Cardiac disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| ANGINA PECTORIS | Cardiac disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| AORTIC VALVE DISEASE | Cardiac disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| MYOCARDIAL INFARCTION | Cardiac disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| NODAL ARRHYTHMIA | Cardiac disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| MYOCARDIAL ISCHAEMIA | Cardiac disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| RETINAL DETACHMENT | Eye disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| ENTEROCOLITIS | Gastrointestinal disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| ENTEROVESICAL FISTULA | Gastrointestinal disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| GASTROOESOPHAGEAL REFLUX DISEASE | Gastrointestinal disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| HAEMATEMESIS | Gastrointestinal disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| HAEMATOCHEZIA | Gastrointestinal disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| INGUINAL HERNIA | Gastrointestinal disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| INTESTINAL PERFORATION | Gastrointestinal disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| PERITONITIS | Gastrointestinal disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| SMALL INTESTINAL OBSTRUCTION | Gastrointestinal disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| ABDOMINAL WALL HAEMATOMA | Gastrointestinal disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| COLITIS | Gastrointestinal disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| CHEST PAIN | General disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| GENERALISED OEDEMA | General disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| HERNIA | General disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| MUCOSAL INFLAMMATION | General disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| NON CARDIAC CHEST PAIN | General disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| PYREXIA | General disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| ANAPHYLACTOID REACTION | Immune system disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| PNEUMONIA | Infections and infestations | MedDRA 14.1 | Non-systematic Assessment |
| |
| DIVERTICULITIS | Infections and infestations | MedDRA 14.1 | Non-systematic Assessment |
| |
| GENITOURINARY TRACT INFECTION | Infections and infestations | MedDRA 14.1 | Non-systematic Assessment |
| |
| NEUTROPENIC INFECTION | Infections and infestations | MedDRA 14.1 | Non-systematic Assessment |
| |
| PERIDIVERTICULAR ABSCESS | Infections and infestations | MedDRA 14.1 | Non-systematic Assessment |
| |
| APPENDICITIS PERFORATED | Infections and infestations | MedDRA 14.1 | Non-systematic Assessment |
| |
| BACTERAEMIA | Infections and infestations | MedDRA 14.1 | Non-systematic Assessment |
| |
| CYSTITIS | Infections and infestations | MedDRA 14.1 | Non-systematic Assessment |
| |
| GROIN ABSCESS | Infections and infestations | MedDRA 14.1 | Non-systematic Assessment |
| |
| UROSEPSIS | Infections and infestations | MedDRA 14.1 | Non-systematic Assessment |
| |
| FEMUR FRACTURE | Injury, poisoning and procedural complications | MedDRA 14.1 | Non-systematic Assessment |
| |
| POST PROCEDURAL HAEMORRHAGE | Injury, poisoning and procedural complications | MedDRA 14.1 | Non-systematic Assessment |
| |
| JOINT DISLOCATION | Injury, poisoning and procedural complications | MedDRA 14.1 | Non-systematic Assessment |
| |
| ALANINE AMINOTRANSFERASE INCREASED | Investigations | MedDRA 14.1 | Non-systematic Assessment |
| |
| ASPARTATE AMINOTRANSFERASE INCREASED | Investigations | MedDRA 14.1 | Non-systematic Assessment |
| |
| DIABETES MELLITUS | Metabolism and nutrition disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| DEHYDRATION | Metabolism and nutrition disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| HYPERKALAEMIA | Metabolism and nutrition disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| TYPE 2 DIABETES MELLITUS | Metabolism and nutrition disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| ARTHRITIS | Musculoskeletal and connective tissue disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| SPINAL COLUMN STENOSIS | Musculoskeletal and connective tissue disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| SYNOVIAL CYST | Musculoskeletal and connective tissue disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| GASTRIC CANCER | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 14.1 | Non-systematic Assessment |
| |
| COLON CANCER | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 14.1 | Non-systematic Assessment |
| |
| DIZZINESS | Nervous system disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| LOSS OF CONSCIOUSNESS | Nervous system disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| MYASTHENIA GRAVIS | Nervous system disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| SCIATICA | Nervous system disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| SYNCOPE | Nervous system disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| BLADDER NECK OBSTRUCTION | Renal and urinary disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| HYDRONEPHROSIS | Renal and urinary disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| PULMONARY EMBOLISM | Respiratory, thoracic and mediastinal disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| PNEUMOMEDIASTINUM | Respiratory, thoracic and mediastinal disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| ILIAC ARTERY STENOSIS | Vascular disorders | MedDRA 14.1 | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| NEUTROPENIA | Blood and lymphatic system disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| ANAEMIA | Blood and lymphatic system disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| LACRIMATION INCREASED | Eye disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| DIARRHOEA | Gastrointestinal disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| NAUSEA | Gastrointestinal disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| CONSTIPATION | Gastrointestinal disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| STOMATITIS | Gastrointestinal disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| VOMITING | Gastrointestinal disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| DYSPEPSIA | Gastrointestinal disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| GASTROOESOPHAGEAL REFLUX DISEASE | Gastrointestinal disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| FATIGUE | General disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| OEDEMA PERIPHERAL | General disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| PYREXIA | General disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| ASTHENIA | General disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| NASOPHARYNGITIS | Infections and infestations | MedDRA 14.1 | Non-systematic Assessment |
| |
| UPPER RESPIRATORY TRACT INFECTION | Infections and infestations | MedDRA 14.1 | Non-systematic Assessment |
| |
| WEIGHT INCREASED | Investigations | MedDRA 14.1 | Non-systematic Assessment |
| |
| ALANINE AMINOTRANSFERASE INCREASED | Investigations | MedDRA 14.1 | Non-systematic Assessment |
| |
| WEIGHT DECREASED | Investigations | MedDRA 14.1 | Non-systematic Assessment |
| |
| DECREASED APPETITE | Metabolism and nutrition disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| HYPERGLYCAEMIA | Metabolism and nutrition disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| ARTHRALGIA | Musculoskeletal and connective tissue disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| PAIN IN EXTREMITY | Musculoskeletal and connective tissue disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| MYALGIA | Musculoskeletal and connective tissue disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| BACK PAIN | Musculoskeletal and connective tissue disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| BONE PAIN | Musculoskeletal and connective tissue disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| DYSGEUSIA | Nervous system disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| NEUROPATHY PERIPHERAL | Nervous system disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| PERIPHERAL SENSORY NEUROPATHY | Nervous system disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| HEADACHE | Nervous system disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| PARAESTHESIA | Nervous system disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| HYPOAESTHESIA | Nervous system disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| DIZZINESS | Nervous system disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| INSOMNIA | Psychiatric disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| POLLAKIURIA | Renal and urinary disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| URINARY INCONTINENCE | Renal and urinary disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| COUGH | Respiratory, thoracic and mediastinal disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| DYSPNOEA | Respiratory, thoracic and mediastinal disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| EPISTAXIS | Respiratory, thoracic and mediastinal disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| HICCUPS | Respiratory, thoracic and mediastinal disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| ALOPECIA | Skin and subcutaneous tissue disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| NAIL DISORDER | Skin and subcutaneous tissue disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| RASH | Skin and subcutaneous tissue disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| DRY SKIN | Skin and subcutaneous tissue disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| ERYTHEMA | Skin and subcutaneous tissue disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| HOT FLUSH | Vascular disorders | MedDRA 14.1 | Non-systematic Assessment |
| |
| HYPERTENSION | Vascular disorders | MedDRA 14.1 | Non-systematic Assessment |
|
The investigator shall provide the Steering Committee a copy of any manuscript, abstract or oral communication derived from the study for review and comment at least 30 days in advance of any submission. The Sponsor's representatives shall have the right to review and/or delay any publication or presentation to prevent disclosure of Sponsor's confidential information and preserve intellectual property rights.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Trial Transparency Team | Sanofi | Contact-Us@sanofi.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 |
|---|---|
| D000077143 | Docetaxel |
| D016729 | Leuprolide |
| C493311 | luprolide acetate gel depot |
| C053541 | bicalutamide |
| ID | Term |
|---|---|
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D004224 | Diterpenes |
| D013729 | Terpenes |
| 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
| Greater Than or Equal to (>=) 65 to < 75 Years |
|
| >= 75 Years |
|
| Male |
|
| Black |
|
| Asian/Oriental |
|
| Others |
|
| No |
| Superiority or Other |
|
|
|
| Participants |
|
|
|
|
| Units | Counts |
|---|
| Participants |
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Leuprolide+Bicalutamide |
Participants received leuprolide 22.5 mg injection subcutaneously every 12 weeks up to 18 months and bicalutamide 50 mg tablet orally once daily for first 4 weeks of treatment. |
|
|
| Participants |
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
| OG001 | Leuprolide+Bicalutamide | Participants received leuprolide 22.5 mg injection subcutaneously every 12 weeks up to 18 months and bicalutamide 50 mg tablet orally once daily for first 4 weeks of treatment. |
|
|