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| Name | Class |
|---|---|
| Almedis | INDUSTRY |
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The objective of this study was to describe treatment patterns of leuprorelin over 2 years using an intermittent, adjuvant regimen in participants with advanced prostate cancer (PCa)
Participants started hormone treatment with Leuprorelin 3.75 mg once every 28 days, subcutaneously (SC) or intramuscularly (IM). Duration of induction therapy was at least 6 months (6-9 months) during which PSA and testosterone levels were measured every 3 months. When PSA decreased by greater than 90% from baseline (PSA less than 10 ng/ml) or became lower than 4.0 ng/ml (for 2 consecutive measurements made at least 2 weeks apart) the participants were included into intermittent hormone therapy regimen group (IAD). Participants with PSA decrease not achieved greater than 90% or less than or equal to 4.0 ng/ml were given either continuous hormone therapy (CAD) or chemotherapy.
Therapy was stopped if participants had PSA decrease greater than 90% from baseline or values less than 4.0 ng/ml after 6-9 months of continuous hormone therapy. PSA and testosterone were measured every 4 weeks. If PSA became greater than or equal to 10.0 ng/ml, hormone therapy was resumed until PSA was less than 4.0 ng/ml for 2 consecutive measurements made at least 2 weeks apart. Duration of hormonal therapy cycle was at least 3 months. Then intermittent treatment was performed according to a similar scheme. PSA and testosterone levels were determined every 12 weeks when hormone therapy was administered and every 4 weeks after it was stopped. The treatment was carried out for 2 years or until Hormone Refractory Prostate Cancer (HRPC) developed.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Advanced PCa | Participants with advanced PCa |
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| Measure | Description | Time Frame |
|---|---|---|
| Mean Duration of Leuprorelin Exposure | Total duration of leuprorelin Intermittent Androgen Deprivation (IAD) regimen was calculated as (Last dose date of Leuprorelin minus first dose date plus 1)/30.4. If the stop date of leuprorelin administration was missing then the date of last attended visit was used. Total duration may include gaps between the cycles. The data are reported as mean months +/- standard deviation. | 24 months |
| Mean Duration of Each Leuprorelin Cycle | Duration of each cycle of leuprorelin IAD regimen was calculated as (Date of last dose of cycle of leuprorelin minus start date of cycle plus 1)/30.4. The data are reported as mean months +/- standard deviation. | 24 months |
| Median Number of Leuprorelin Cycles | The Participants were on IAD regimen and the data are reported as number of cycles with full range. | 24 months |
| Percentage of Participants Who Discontinued From Leuprorelin Administration of IAD Regimen | The data are reported as percentage of participants. | 24 months |
| Number of Participants Who Switched to IAD Regimen by Visit | The data are reported as number of participants. | 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Who Progressed to Hormone Refractory Prostate Cancer (HRPC) | Progression to HRPC was defined as castrate serum testosterone less than 50 ng/dL or 1.7 nmol/L plus either; biochemical progression (three consecutive rises in prostate specific antigen (PSA) levels one week apart resulting in two 50 % increases over the nadir, with PSA greater than 2 ng/ml) or radiological progression (the appearance of two or more new bone lesions on bone scan or enlargement of a soft tissue lesion using Response Evaluation Criteria in Solid Tumors (RECIST). Data are reported as number of participants with HRPC. |
| Measure | Description | Time Frame |
|---|---|---|
| Duration of IAD Regimen Induction Phase | Time period between first injection of leuprorelin and stopping of treatment due to appropriate decrease of PSA as defined in the protocol. The data are reported as mean months +/- standard deviation. | At least 6-9 months after Baseline (enrollment) |
| Number of Participants Who Received IAD Regimen During the Study |
Inclusion Criteria:
Histologically confirmed advanced PCa meeting the following criteria:
Participants planned for administration of leuprorelin
World Health Organization status 0-1
Life expectancy at least 2 years
Exclusion Criteria:
Contraindications to administration of leuprorelin:
Hormone-refractory PCa
Presence of another malignant tumor (except skin cancer)
Previous administration of hormone therapy with gonadotropin-releasing hormone agonists or antiandrogens
Previous administration of radiotherapy or chemotherapy course within 1 month
Testosterone level less than or equal to 50 ng/dl (less than or equal to 1.7 mmol/l) at time of inclusion
Extremely high level of PSA (greater than or equal to 1000 ng/ml)
Other severe diseases in stage of decompensation
Other contraindications, that make the participant's participation impossible (by investigator judgment)
Previous enrollment in the present program
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Participants with advanced PCa
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| Name | Affiliation | Role |
|---|---|---|
| Andrey Strugovshchikov, MD | AbbVie | Study Director |
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| Label | URL |
|---|---|
| Related Info | View source |
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From 300 participants enrolled in the study, data of 17 participants from one of the sites were excluded from analysis because of the impossibility to contact the investigator for data clarification. Hence 283 participants were included in the analysis.
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| ID | Title | Description |
|---|---|---|
| FG000 | Advanced Prostate Cancer (PCa) | Participants with advanced PCa |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Baseline (enrollment), after 1 year, after 2 years, and 30 days from 2 year visit |
| Median Time to Progression of HRPC | Time to progression of HRPC was calculated as date of progression minus date of first dose of leuprorelin. The data are reported as median (full range). | Baseline (enrollment), after 1 year, after 2 years, and 30 days from 2 year visit |
| Median Time to Progression of HRPC in Participants Not Started on IAD Regimen | Time to progression of HRPC was calculated as date of progression minus date of first dose of leuprorelin. A Kaplan-Meier estimate of median time to progression to HRPC and 25% and 75% quartiles along with the 95% confidence interval for median were assessed. | Baseline (enrollment), after 1 year, after 2 years, and 30 days from 2 year visit |
| Median Survival Time | Time to survival was estimated as time from start of leuprorelin up to study completion/discontinuation from the study or date of death. The data are reported as median months with full range. | Baseline (enrollment), after 1 year, after 2 years, and 30 days from 2 year visit |
| Mean Duration of Treatment-off Time in IAD Regimen | Duration of each leuprorelin free period was calculated as (Date of first dose of leuprorelin [cycle N+1] minus last dose date [cycle N] minus 1)/30.4. If date of last dose of leuprorelin was before the date of study completion/discontinuation then the last leuprorelin free period was calculated as (Date of discontinuation/study completion minus last leuprorelin dose date)/30.4. The data are reported as mean months +/- standard deviation. | Baseline (enrollment), after 1 year, after 2 years, and 30 days from 2 year visit |
| Median Percentage of Time Off-treatment During 2 Years IAD Regimen | The total duration of leuprorelin free period was calculated as the sum of all leuprorelin free periods. The data are reported as median percentage of time off-treatment with full range. | Baseline (enrollment), after 1 year, after 2 years, and 30 days from 2 year visit |
The data are reported as number of participants. |
| 24 months |
| Number of Participants Who Continued to Take Leuprorelin in IAD Regimen by the End of the Study | The data are reported as number of participants. | 24 months |
| COMPLETED |
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| NOT COMPLETED |
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Data are of measurements collected from the safety analysis set, defined as all participants who signed an informed consent form and were administered at least one dose of Leuprorelin.
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| ID | Title | Description |
|---|---|---|
| BG000 | Advanced PCa | Participants with advanced PCa |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Other Pre-specified | Duration of IAD Regimen Induction Phase | Time period between first injection of leuprorelin and stopping of treatment due to appropriate decrease of PSA as defined in the protocol. The data are reported as mean months +/- standard deviation. | Data are of measurements collected from participants who started IAD. | Posted | Mean | Standard Deviation | Months | At least 6-9 months after Baseline (enrollment) |
|
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| ||||||||||||||||||||||||||||||||||
| Primary | Mean Duration of Leuprorelin Exposure | Total duration of leuprorelin Intermittent Androgen Deprivation (IAD) regimen was calculated as (Last dose date of Leuprorelin minus first dose date plus 1)/30.4. If the stop date of leuprorelin administration was missing then the date of last attended visit was used. Total duration may include gaps between the cycles. The data are reported as mean months +/- standard deviation. | Data are of measurements collected from the safety analysis set, defined as all participants who signed an informed consent form and were administered at least one dose of leuprorelin. | Posted | Mean | Standard Deviation | Months | 24 months |
|
| |||||||||||||||||||||||||||||||||||
| Primary | Mean Duration of Each Leuprorelin Cycle | Duration of each cycle of leuprorelin IAD regimen was calculated as (Date of last dose of cycle of leuprorelin minus start date of cycle plus 1)/30.4. The data are reported as mean months +/- standard deviation. | Data are of measurements collected from the safety analysis set, defined as all participants who signed an informed consent form and were administered at least one dose of leuprorelin. | Posted | Mean | Standard Deviation | Months | 24 months |
|
| |||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants Who Progressed to Hormone Refractory Prostate Cancer (HRPC) | Progression to HRPC was defined as castrate serum testosterone less than 50 ng/dL or 1.7 nmol/L plus either; biochemical progression (three consecutive rises in prostate specific antigen (PSA) levels one week apart resulting in two 50 % increases over the nadir, with PSA greater than 2 ng/ml) or radiological progression (the appearance of two or more new bone lesions on bone scan or enlargement of a soft tissue lesion using Response Evaluation Criteria in Solid Tumors (RECIST). Data are reported as number of participants with HRPC. | Data are of measurements collected from the full analysis set, defined as all participants who received at least one dose of leuprorelin, signed informed consent, did not violate any inclusion/exclusion criteria and attended at least one post-baseline visit. | Posted | Number | Participants | Baseline (enrollment), after 1 year, after 2 years, and 30 days from 2 year visit |
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| Primary | Median Number of Leuprorelin Cycles | The Participants were on IAD regimen and the data are reported as number of cycles with full range. | Data are of measurements collected from the safety analysis set, defined as all participants who signed an informed consent form and were administered at least one dose of leuprorelin. However, one participant started continuous hormone therapy and was not included in the analysis. | Posted | Median | Full Range | Cycles | 24 months |
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| Secondary | Median Time to Progression of HRPC | Time to progression of HRPC was calculated as date of progression minus date of first dose of leuprorelin. The data are reported as median (full range). | Data are of measurements collected from the full analysis set, defined as all participants who received at least one dose of leuprorelin, signed informed consent, did not violate any inclusion/exclusion criteria and attended at least one post-baseline visit. | Posted | Median | Full Range | Months | Baseline (enrollment), after 1 year, after 2 years, and 30 days from 2 year visit |
|
| |||||||||||||||||||||||||||||||||||
| Secondary | Median Time to Progression of HRPC in Participants Not Started on IAD Regimen | Time to progression of HRPC was calculated as date of progression minus date of first dose of leuprorelin. A Kaplan-Meier estimate of median time to progression to HRPC and 25% and 75% quartiles along with the 95% confidence interval for median were assessed. | Data are of measurements of participants who did not start on IAD regimen. | Posted | Median | 95% Confidence Interval | Months | Baseline (enrollment), after 1 year, after 2 years, and 30 days from 2 year visit |
|
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| Secondary | Median Survival Time | Time to survival was estimated as time from start of leuprorelin up to study completion/discontinuation from the study or date of death. The data are reported as median months with full range. | Participants who died while on study were used for analysis. | Posted | Median | Full Range | Months | Baseline (enrollment), after 1 year, after 2 years, and 30 days from 2 year visit |
|
| |||||||||||||||||||||||||||||||||||
| Other Pre-specified | Number of Participants Who Received IAD Regimen During the Study | The data are reported as number of participants. | Data are of measurements collected from participants who started IAD. | Posted | Number | Participants | 24 months |
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| Other Pre-specified | Number of Participants Who Continued to Take Leuprorelin in IAD Regimen by the End of the Study | The data are reported as number of participants. | Data are of measurements collected from participants who started IAD. | Posted | Number | Participants | 24 months |
|
| ||||||||||||||||||||||||||||||||||||
| Primary | Percentage of Participants Who Discontinued From Leuprorelin Administration of IAD Regimen | The data are reported as percentage of participants. | Data are of measurements collected from the safety analysis set, defined as all participants who signed an informed consent form and were administered at least one dose of leuprorelin. | Posted | Number | Percentage of participants | 24 months |
|
| ||||||||||||||||||||||||||||||||||||
| Secondary | Mean Duration of Treatment-off Time in IAD Regimen | Duration of each leuprorelin free period was calculated as (Date of first dose of leuprorelin [cycle N+1] minus last dose date [cycle N] minus 1)/30.4. If date of last dose of leuprorelin was before the date of study completion/discontinuation then the last leuprorelin free period was calculated as (Date of discontinuation/study completion minus last leuprorelin dose date)/30.4. The data are reported as mean months +/- standard deviation. | Data are of measurements collected from participants who started IAD. | Posted | Mean | Standard Deviation | Months | Baseline (enrollment), after 1 year, after 2 years, and 30 days from 2 year visit |
|
| |||||||||||||||||||||||||||||||||||
| Primary | Number of Participants Who Switched to IAD Regimen by Visit | The data are reported as number of participants. | Data are of measurements collected from the safety analysis set, defined as all participants who signed an informed consent form and were administered at least one dose of leuprorelin. | Posted | Number | Participants | 24 months |
|
| ||||||||||||||||||||||||||||||||||||
| Secondary | Median Percentage of Time Off-treatment During 2 Years IAD Regimen | The total duration of leuprorelin free period was calculated as the sum of all leuprorelin free periods. The data are reported as median percentage of time off-treatment with full range. | Data are of measurements collected from participants who started IAD. | Posted | Median | Full Range | Percentage of time off-treatment | Baseline (enrollment), after 1 year, after 2 years, and 30 days from 2 year visit |
|
|
From signing of informed consent up to 24 months of observation of treatment period and 30 days of follow up period
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Advanced PCa | Participants with advanced PCa | 13 | 283 | 73 | 283 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| DISEASE PROGRESSION | General disorders | MedDRA v 17 | Non-systematic Assessment |
| |
| CARDIAC DISORDER | Cardiac disorders | MedDRA v 17 | Non-systematic Assessment |
| |
| MYOCARDIAL INFARCTION | Cardiac disorders | MedDRA v 17 | Non-systematic Assessment |
| |
| PROSTATE CANCER | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v 17 | Non-systematic Assessment |
| |
| RENAL CANCER | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v 17 | Non-systematic Assessment |
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| CHOLECYSTITIS ACUTE | Hepatobiliary disorders | MedDRA v 17 | Non-systematic Assessment |
| |
| URINARY RETENTION | Renal and urinary disorders | MedDRA v 17 | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| NASOPHARYNGITIS | Infections and infestations | MedDRA v 17 | Non-systematic Assessment |
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| BRONCHITIS | Infections and infestations | MedDRA v 17 | Non-systematic Assessment |
| |
| PNEUMONIA | Infections and infestations | MedDRA v 17 | Non-systematic Assessment |
| |
| DISEASE PROGRESSION | General disorders | MedDRA v 17 | Non-systematic Assessment |
| |
| FATIGUE | General disorders | MedDRA v 17 | Non-systematic Assessment |
| |
| ASTHENIA | General disorders | MedDRA v 17 | Non-systematic Assessment |
| |
| OEDEMA | General disorders | MedDRA v 17 | Non-systematic Assessment |
| |
| HOT FLUSH | Vascular disorders | MedDRA v 17 | Non-systematic Assessment |
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| HYPERTENSION | Vascular disorders | MedDRA v 17 | Non-systematic Assessment |
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| GYNAECOMASTIA | Reproductive system and breast disorders | MedDRA v 17 | Non-systematic Assessment |
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| BREAST ENLARGEMENT | Reproductive system and breast disorders | MedDRA v 17 | Non-systematic Assessment |
| |
| ACQUIRED HYDROCELE | Reproductive system and breast disorders | MedDRA v 17 | Non-systematic Assessment |
| |
| ERECTILE DYSFUNCTION | Reproductive system and breast disorders | MedDRA v 17 | Non-systematic Assessment |
| |
| GASTRITIS | Gastrointestinal disorders | MedDRA v 17 | Non-systematic Assessment |
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| PEPTIC ULCER | Gastrointestinal disorders | MedDRA v 17 | Non-systematic Assessment |
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| GASTRIC ULCER | Gastrointestinal disorders | MedDRA v 17 | Non-systematic Assessment |
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| DERMATITIS | Skin and subcutaneous tissue disorders | MedDRA v 17 | Non-systematic Assessment |
| |
| DIABETES MELLITUS | Metabolism and nutrition disorders | MedDRA v 17 | Non-systematic Assessment |
| |
| COUGH | Respiratory, thoracic and mediastinal disorders | MedDRA v 17 | Non-systematic Assessment |
| |
| CARDIAC DISORDER | Cardiac disorders | MedDRA v 17 | Non-systematic Assessment |
| |
| MYOCARDIAL INFARCTION | Cardiac disorders | MedDRA v 17 | Non-systematic Assessment |
| |
| ARTHRITIS | Musculoskeletal and connective tissue disorders | MedDRA v 17 | Non-systematic Assessment |
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| ARTHROPATHY | Musculoskeletal and connective tissue disorders | MedDRA v 17 | Non-systematic Assessment |
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| PROSTATE CANCER | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v 17 | Non-systematic Assessment |
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| RENAL CANCER | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v 17 | Non-systematic Assessment |
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| CHOLECYSTITIS ACUTE | Hepatobiliary disorders | MedDRA v 17 | Non-systematic Assessment |
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| RIB FRACTURE | Injury, poisoning and procedural complications | MedDRA v 17 | Non-systematic Assessment |
| |
| DEPRESSION | Psychiatric disorders | MedDRA v 17 | Non-systematic Assessment |
| |
| URINARY RETENTION | Renal and urinary disorders | MedDRA v 17 | Non-systematic Assessment |
|
AbbVie requests that any investigator or institution that plans on presenting/publishing results disclosure, provide written notification of their request 60 days prior to their presentation/publication. AbbVie requests that no presentation/publication will be instituted until 12 months after a study is completed, or after the first presentation/publication whichever occurs first. A delay may be proposed of a presentation/publication if AbbVie needs to secure patent or proprietary protection.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Global Medical Services | AbbVie (prior sponsor, Abbott) | 800-633-9110 |
| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
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| Title | Denominators | Categories | ||||
|---|---|---|---|---|---|---|
| All Participants (N=4) |
| |||||
| Participants who started IAD (N=2) |
| |||||
| Participants who did not start IAD (N=2) |
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| Denominators |
|---|
| Categories |
|---|
| All participants |
| |||||
| Participants with no progression |
| |||||
| Participants with progression |
|
| Title |
|---|
| Denominators |
|---|
| Categories |
|---|
| All participants |
| |||||
| Participants with no progression (N=210) |
| |||||
| Participants with progression (N=33) |
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| Title | Denominators | Categories | ||||
|---|---|---|---|---|---|---|
| Overall Study |
| |||||
| Cycle 1 |
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| Cycle 2 (N=240) |
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| Cycle 3 (N=119) |
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| Cycle 4 (N=17) |
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| Cycle 5 (N=1) |
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| Title | Denominators | Categories | ||||
|---|---|---|---|---|---|---|
| Visit 2 After One Year (N=257) |
| |||||
| Visit 3 After Two Years (N=225) |
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