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Document treatment patterns and evaluate LUCRIN / LUCRIN-TRIDEPOT® (Leuprolide) and alternative therapeutic approaches to the treatment of advanced prostate cancer during normal clinical practice and in accordance with the terms of the Belgian marketing authorization and reimbursement conditions.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Advanced prostate cancer participants | Participants with advanced prostate cancer treated with Lucrin /Lucrin- Tri-depot (leuprolide) or any other treatment within local reimbursement guidelines. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| leuprolide (Lucrin/Lucrin-Tri-depot) | Drug | Subcutaneous or intramuscular administration for all participants |
|
| Measure | Description | Time Frame |
|---|---|---|
| Effectiveness Parameter for Staging of Prostate Cancer: Metastases at Each Visit | The number of participants with metastases that are absent, local tumor, single metastases, multiple metastases in 1 organ, and multiple metastases in multiple organs at each visit is summarized. | time 0 (Baseline), month 3, and every 3 months until disease progression or up to 24 months, whichever came first |
| Effectiveness Parameter for Screening or Recurrence of Prostate Cancer: Mean Prostate-specific Antigen (PSA) at Each Visit | The mean PSA in ng/mL to screen and assess for the recurrence of prostate cancer at each visit is presented. | time 0 (Baseline), month 3, and every 3 months until disease progression or up to 24 months, whichever came first |
| Effectiveness Parameter: the Number of Participants With a Complete or Partial Response, Stable Disease, or Progressive Disease Following Treatment at Each Visit | Response to treatment is summarized by the number of participants at each visit with a complete or partial response, stable disease, or progressive disease. Disease status determination was not predefined, but was based on the judgement of each Investigator. | month 3, and every 3 months until disease progression or up to 24 months, whichever came first |
| Effectiveness Parameter for Prognosis: the Number of Participants With a Survival Prognosis of > 10 Years, 5 - 10 Years, 1 - 5 Years, 6 - 12 Months, and < 6 Months | The prognosis for participants is summarized for each visit by the number of participants at each visit with a survival prognosis of 10 years, 5 - 10 years, 1 - 5 years, 6 - 12 months, and < 6 months. Methods for determining survival prognosis were not prespecified, but were based on the judgement of each Investigator. | time 0 (Baseline), month 3, and every 3 months thereafter until disease progression or up to 24 months, whichever came first |
| Measure | Description | Time Frame |
|---|---|---|
| Safety Parameter: Number of Participants Reporting Serious Adverse Events (SAEs) | The number of participants experiencing a serious adverse event during the course of the study is summarized. See the Reported Adverse Event section for details. | Baseline to disease progression or 24 months, whichever came first |
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Inclusion Criteria:
Exclusion Criteria:
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Urologists
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| Name | Affiliation | Role |
|---|---|---|
| Simonne Lens | Abbott | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Site Reference ID/Investigator# 31147 | 's-Gravenwezel | B-2970 | Belgium | |||
| Site Reference ID/Investigator# 31196 |
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| ID | Title | Description |
|---|---|---|
| FG000 | Advanced Prostate Cancer Participants | Participants with advanced prostate cancer treated with Lucrin /Lucrin- Tri-depot (leuprolide) or any other treatment with local reimbursement guidelines. No Baseline data was available for 3 patients who were thus excluded from all analyses. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Treatment Patterns for Prostate Cancer Treatments: Number of Participants at Each Visit Who Took Lucrin/Lucrin Tridepot, Luteinizing Hormone-releasing Hormone (LHRH) Agonists, Anti-androgens, or Other Drug Treatments, or Who Had Surgery or Radiotherapy. |
Prostate cancer treatment for all participants is summarized by the number of participants at each visit who took any Lucrin/Lucrin Tridepot, LHRH agonist, anti-androgens, or other drug treatments, or who had any type of surgery or radiotherapy (external radiation or brachytherapy). |
| time 0 (Baseline), month 3, and every 3 months until disease progression or up to 24 months, whichever came first |
| Epidemiological Data: Mean Weight |
The mean weight of all participants at baseline is provided. |
| at time 0 (Baseline) |
| Epidemiological Data: Mean Age | The mean age of all participants at baseline is provided. | at time 0 (Baseline) |
| Epidemiological Data: Race | The number of participants by race at baseline is presented. | at time 0 (Baseline) |
| Epidemiological Data: Tumor Staging - Among Participants With a Positive Biopsy, the Number of Participants With Adenocarcinoma Tissue or Other Tissues Recorded for the Positive Biopsy. | Among those participants with a positive biopsy at baseline, the number of participants with adenocarcinoma tissue or other tissue type is summarized. | at time 0 (Baseline) |
| Epidemiological Data: PSA at Baseline | The median, minimum, and maximum PSA values in ng/mL at baseline are provided. The mean PSA at baseline is reported in the Primary Outcome Measure section above. | at time 0 (Baseline) |
| Epidemiological Data: Tumor Staging (Positive or Negative) Via a Rectal Examination, Prostate Biopsy, Echograph, or Magnetic Resonance Imaging (MRI) Test. | The number of participants at baseline who were positive or negative for tumors via a rectal examination, prostate biopsy, echograph of the hyperechogenic zones, or MRI are provided. | at time 0 (Baseline) |
| Epidemiological Data: the Number of Participants With Tumor Stages T0, T1, T2, T3, and T4. | The number of participants with tumor stages T0, T1, T2, T3, and T4 as reported by the physician or pathologist is summarized. T0: no evidence of primary tumor. T1: histologic tumor confined to prostate; clinically unapparent tumor, undetectable by digital rectal examination or by ultrasound. T2: tumor is confined to prostrate and can be detected by digital rectal examination. T3: tumor extends through the prostate capsule but has not spread to other organs. T4: tumor has invaded adjacent structures/organs other than seminal vesicles. | at time 0 (Baseline) |
| Epidemiological Data: Node Staging - the Number of Participants With a Positive or Negative Computerized Tomography (CT) Scan or Magnetic Resonance Imaging (MRI) Test | In this case, a CT or MRI is considered positive when lymph nodes are detectable. A CT or MRI is considered negative when lymph nodes are not detectable. | at time 0 (Baseline) |
| Epidemiological Data: Node Staging - the Number of Participants With a N0 or N1 Stage at Baseline. | N0: tumor cells absent from regional lymph nodes. N1: regional lymph node metastasis present. | at time 0 (Baseline) |
| Epidemiological Data: Bone Scan at Baseline | The number of participants at baseline with a positive or negative bone scan was summarized. Determination of bone scan status was based on the interpretation of the Investigator or radiologist. | at time 0 (Baseline) |
| Epidemiological Data: Metastasis Staging (M0 or M1) at Baseline | The number of participants at baseline reported to be in metastasis stage M0 or M1 is summarized. M0: no distant metastasis. M1: metastasis to distant organs beyond regional lymph nodes. | at time 0 (Baseline) |
| Aartselaar |
| B-2630 |
| Belgium |
| Site Reference ID/Investigator# 31237 | Afsnee | B-9051 | Belgium |
| Site Reference ID/Investigator# 31121 | Alken | B-3570 | Belgium |
| Site Reference ID/Investigator# 31170 | Antwerp | B-2018 | Belgium |
| Site Reference ID/Investigator# 31194 | Antwerp | B-2018 | Belgium |
| Site Reference ID/Investigator# 4872 | Antwerp | B-2020 | Belgium |
| Site Reference ID/Investigator# 31186 | Antwerp | B-2050 | Belgium |
| Site Reference ID/Investigator# 31141 | Arlon | B-6700 | Belgium |
| Site Reference ID/Investigator# 31199 | Arlon | B-6700 | Belgium |
| Site Reference ID/Investigator# 31247 | Ath | B-7804 | Belgium |
| Site Reference ID/Investigator# 31190 | Baulers | B-1401 | Belgium |
| Site Reference ID/Investigator# 31210 | Beerse | B-2340 | Belgium |
| Site Reference ID/Investigator# 31171 | Berchem | B-2600 | Belgium |
| Site Reference ID/Investigator# 31137 | Berlaar | B-2590 | Belgium |
| Site Reference ID/Investigator# 31204 | Beveren | B-8800 | Belgium |
| Site Reference ID/Investigator# 31184 | Boutersem | B-3370 | Belgium |
| Site Reference ID/Investigator# 31205 | Braine-le-Château | B-1440 | Belgium |
| Site Reference ID/Investigator# 31217 | Brasschaat | B-2930 | Belgium |
| Site Reference ID/Investigator# 31133 | Bruges | B-8310 | Belgium |
| Site Reference ID/Investigator# 31134 | Bruges | B-8310 | Belgium |
| Site Reference ID/Investigator# 31135 | Bruges | B-8310 | Belgium |
| Site Reference ID/Investigator# 31233 | Brussels | B-1000 | Belgium |
| Site Reference ID/Investigator# 31161 | Brussels | B-1020 | Belgium |
| Site Reference ID/Investigator# 31223 | Brussels | B-1030 | Belgium |
| Site Reference ID/Investigator# 31152 | Brussels | B-1050 | Belgium |
| Site Reference ID/Investigator# 31251 | Brussels | B-1081 | Belgium |
| Site Reference ID/Investigator# 31178 | Brussels | B-1083 | Belgium |
| Site Reference ID/Investigator# 31236 | Brussels | B-1090 | Belgium |
| Site Reference ID/Investigator# 31252 | Brussels | B-1160 | Belgium |
| Site Reference ID/Investigator# 31117 | Brussels | B-1180 | Belgium |
| Site Reference ID/Investigator# 31203 | Brussels | B-1180 | Belgium |
| Site Reference ID/Investigator# 31232 | Brussels | B-1200 | Belgium |
| Site Reference ID/Investigator# 31200 | Brussels | B-1853 | Belgium |
| Site Reference ID/Investigator# 31129 | Court-Saint-Étienne | B-1490 | Belgium |
| Site Reference ID/Investigator# 31244 | Cuesmes | B-7033 | Belgium |
| Site Reference ID/Investigator# 31208 | Damme | B-8340 | Belgium |
| Site Reference ID/Investigator# 31155 | Dendermonde | B-9200 | Belgium |
| Site Reference ID/Investigator# 31197 | Dendermonde | B-9200 | Belgium |
| Site Reference ID/Investigator# 31189 | Diest | B-3290 | Belgium |
| Site Reference ID/Investigator# 31126 | Dilbeek | B-1700 | Belgium |
| Site Reference ID/Investigator# 31116 | Dworp | B-1653 | Belgium |
| Site Reference ID/Investigator# 31160 | Dworp | B-1653 | Belgium |
| Site Reference ID/Investigator# 31179 | Elingen | B-1671 | Belgium |
| Site Reference ID/Investigator# 31249 | Embourg | B-4053 | Belgium |
| Site Reference ID/Investigator# 31166 | Erpent | B-5101 | Belgium |
| Site Reference ID/Investigator# 31192 | Esneux | B-4130 | Belgium |
| Site Reference ID/Investigator# 31188 | Falmagne | B-5500 | Belgium |
| Site Reference ID/Investigator# 31195 | Feluy | B-7181 | Belgium |
| Site Reference ID/Investigator# 31250 | Floreffe | B-5150 | Belgium |
| Site Reference ID/Investigator# 31183 | Genk | B-3600 | Belgium |
| Site Reference ID/Investigator# 31173 | Genk-Waterschei | B-3600 | Belgium |
| Site Reference ID/Investigator# 31228 | Ghent | B-9000 | Belgium |
| Site Reference ID/Investigator# 46502 | Ghent | B-9000 | Belgium |
| Site Reference ID/Investigator# 31132 | Gouy-Les-Pietons | B-6181 | Belgium |
| Site Reference ID/Investigator# 31124 | Halle | B-1500 | Belgium |
| Site Reference ID/Investigator# 31191 | Hamme | B-9220 | Belgium |
| Site Reference ID/Investigator# 31234 | Hasselt | B-3510 | Belgium |
| Site Reference ID/Investigator# 31227 | Heusy | B-4802 | Belgium |
| Site Reference ID/Investigator# 31212 | Hofstade | B-1981 | Belgium |
| Site Reference ID/Investigator# 31143 | Hove | B-2540 | Belgium |
| Site Reference ID/Investigator# 31226 | Huy | B-4500 | Belgium |
| Site Reference ID/Investigator# 31119 | Izegem | B-8870 | Belgium |
| Site Reference ID/Investigator# 31181 | Izegem | B-8870 | Belgium |
| Site Reference ID/Investigator# 31149 | Knokke | B-8300 | Belgium |
| Site Reference ID/Investigator# 31177 | Koksijde | B-8670 | Belgium |
| Site Reference ID/Investigator# 31253 | Kortrijk | B-8500 | Belgium |
| Site Reference ID/Investigator# 31130 | Lasne | B-1380 | Belgium |
| Site Reference ID/Investigator# 31159 | Lennik | B-1750 | Belgium |
| Site Reference ID/Investigator# 31123 | Leper | B-8900 | Belgium |
| Site Reference ID/Investigator# 31241 | Leper | B-8900 | Belgium |
| Site Reference ID/Investigator# 31255 | Lesves | B-1380 | Belgium |
| Site Reference ID/Investigator# 31259 | Leuven | 3000 | Belgium |
| Site Reference ID/Investigator# 31219 | Libramont | B-6800 | Belgium |
| Site Reference ID/Investigator# 31224 | Lier | B2400 | Belgium |
| Site Reference ID/Investigator# 31128 | Liège | B-4000 | Belgium |
| Site Reference ID/Investigator# 31144 | Liège | B-4000 | Belgium |
| Site Reference ID/Investigator# 31185 | Liège | B-4000 | Belgium |
| Site Reference ID/Investigator# 31207 | Liège | B-4000 | Belgium |
| Site Reference ID/Investigator# 31245 | Liège | B-4000 | Belgium |
| Site Reference ID/Investigator# 31243 | Lommel | B-3920 | Belgium |
| Site Reference ID/Investigator# 31225 | Marcinelle | B-6001 | Belgium |
| Site Reference ID/Investigator# 31139 | Mark | B-7850 | Belgium |
| Site Reference ID/Investigator# 31206 | Mol | B-2400 | Belgium |
| Site Reference ID/Investigator# 31153 | Mons | B-7000 | Belgium |
| Site Reference ID/Investigator# 31257 | Mons | B-7000 | Belgium |
| Site Reference ID/Investigator# 31140 | Mont-sur-Marchienne | B-6032 | Belgium |
| Site Reference ID/Investigator# 31222 | Mortsel | B2640 | Belgium |
| Site Reference ID/Investigator# 31164 | Namur | B-5000 | Belgium |
| Site Reference ID/Investigator# 31258 | Nivelles | B-1400 | Belgium |
| Site Reference ID/Investigator# 31218 | Oordegem | B-9340 | Belgium |
| Site Reference ID/Investigator# 31156 | Oosterzele | B-9860 | Belgium |
| Site Reference ID/Investigator# 31214 | Ostend | B-8400 | Belgium |
| Site Reference ID/Investigator# 31242 | Ostend | B-8400 | Belgium |
| Site Reference ID/Investigator# 31131 | Ottignies | B-1340 | Belgium |
| Site Reference ID/Investigator# 31163 | Oudenaarde | B-9700 | Belgium |
| Site Reference ID/Investigator# 31125 | Overijse | B-3090 | Belgium |
| Site Reference ID/Investigator# 31198 | Pollinkhove | B-8647 | Belgium |
| Site Reference ID/Investigator# 31229 | Ragnies | B-6532 | Belgium |
| Site Reference ID/Investigator# 31138 | Rijmenam | B-2820 | Belgium |
| Site Reference ID/Investigator# 31122 | Roeselare | B-8800 | Belgium |
| Site Reference ID/Investigator# 31174 | Roeslare | B-8800 | Belgium |
| Site Reference ID/Investigator# 31136 | Rotselaar | B-3110 | Belgium |
| Site Reference ID/Investigator# 31180 | Rumbeke | B-8800 | Belgium |
| Site Reference ID/Investigator# 31157 | Saint Truiden | B-3800 | Belgium |
| Site Reference ID/Investigator# 31150 | Saint-Denis | B-7034 | Belgium |
| Site Reference ID/Investigator# 31215 | Saint-Ghislain | B-7330 | Belgium |
| Site Reference ID/Investigator# 31176 | Saintes | B-1480 | Belgium |
| Site Reference ID/Investigator# 31168 | Schilde | B-2970 | Belgium |
| Site Reference ID/Investigator# 31220 | Schoten | B-2900 | Belgium |
| Site Reference ID/Investigator# 31238 | Schoten | B-2900 | Belgium |
| Site Reference ID/Investigator# 31142 | Seneffe | B-7180 | Belgium |
| Site Reference ID/Investigator# 31158 | Seraing | B-4100 | Belgium |
| Site Reference ID/Investigator# 31246 | Silly | B-7830 | Belgium |
| Site Reference ID/Investigator# 31230 | Sint-Genesius-Rode | B-1640 | Belgium |
| Site Reference ID/Investigator# 31240 | Sint-Niklaas | B-9100 | Belgium |
| Site Reference ID/Investigator# 31120 | Sint-Truiden | B-3800 | Belgium |
| Site Reference ID/Investigator# 31213 | Sirault | B-7332 | Belgium |
| Site Reference ID/Investigator# 31182 | Tielt | B-8700 | Belgium |
| Site Reference ID/Investigator# 31248 | Tilff | B-4130 | Belgium |
| Site Reference ID/Investigator# 31151 | Tournai | B-7500 | Belgium |
| Site Reference ID/Investigator# 31146 | Tremelo | B-3120 | Belgium |
| Site Reference ID/Investigator# 31254 | Uccle | B-1180 | Belgium |
| Site Reference ID/Investigator# 31256 | Uccle | B-1180 | Belgium |
| Site Reference ID/Investigator# 31165 | Veerle | B-2431 | Belgium |
| Site Reference ID/Investigator# 31193 | Villers-Saint-Siméon | B-4453 | Belgium |
| Site Reference ID/Investigator# 31175 | Wanze | B-4520 | Belgium |
| Site Reference ID/Investigator# 31145 | Waregem | B-8790 | Belgium |
| Site Reference ID/Investigator# 31202 | Wilrijk | B-2610 | Belgium |
| Site Reference ID/Investigator# 31201 | Woluwe-Saint-Pierre - Sint-Pieters-Woluwe | B-1150 | Belgium |
| Site Reference ID/Investigator# 31216 | Xhendelesse | B-4652 | Belgium |
| Site Reference ID/Investigator# 31221 | Bascharage | L-4918 | Luxembourg |
| Site Reference ID/Investigator# 31172 | Esch-sur-Alzette | L-4243 | Luxembourg |
| Site Reference ID/Investigator# 31162 | Ettelbruck | L-9002 | Luxembourg |
| Site Reference ID/Investigator# 31231 | Luxembourg | L-2540 | Luxembourg |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Advanced Prostate Cancer Participants | Participants with advanced prostate cancer treated with Lucrin /Lucrin- Tri-depot (leuprolide) or any other treatment with local reimbursement guidelines. No Baseline data was available for 3 patients who were thus excluded from all analyses. Age was available for 2,691 patients only; age was missing for 23 patients who were thus not included in the age results. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age Continuous | Median | Full Range | years |
| |||||||||||||||||
| Age Continuous | Mean | Standard Deviation | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | 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 | Effectiveness Parameter for Staging of Prostate Cancer: Metastases at Each Visit | The number of participants with metastases that are absent, local tumor, single metastases, multiple metastases in 1 organ, and multiple metastases in multiple organs at each visit is summarized. | Analysis was performed on the full analysis set (all patients for whom at least baseline data were recorded) and all available data at each visit. | Posted | Number | participants | time 0 (Baseline), month 3, and every 3 months until disease progression or up to 24 months, whichever came first |
|
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| Primary | Effectiveness Parameter for Screening or Recurrence of Prostate Cancer: Mean Prostate-specific Antigen (PSA) at Each Visit | The mean PSA in ng/mL to screen and assess for the recurrence of prostate cancer at each visit is presented. | Analysis was performed on the full analysis set (all patients for whom at least baseline data were recorded) and all available data at each visit. | Posted | Mean | Standard Deviation | ng/mL | time 0 (Baseline), month 3, and every 3 months until disease progression or up to 24 months, whichever came first |
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| Primary | Effectiveness Parameter: the Number of Participants With a Complete or Partial Response, Stable Disease, or Progressive Disease Following Treatment at Each Visit | Response to treatment is summarized by the number of participants at each visit with a complete or partial response, stable disease, or progressive disease. Disease status determination was not predefined, but was based on the judgement of each Investigator. | Analysis was performed on the full analysis set (all patients for whom at least baseline data were recorded) and all available data at each visit. | Posted | Number | participants | month 3, and every 3 months until disease progression or up to 24 months, whichever came first |
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| Primary | Effectiveness Parameter for Prognosis: the Number of Participants With a Survival Prognosis of > 10 Years, 5 - 10 Years, 1 - 5 Years, 6 - 12 Months, and < 6 Months | The prognosis for participants is summarized for each visit by the number of participants at each visit with a survival prognosis of 10 years, 5 - 10 years, 1 - 5 years, 6 - 12 months, and < 6 months. Methods for determining survival prognosis were not prespecified, but were based on the judgement of each Investigator. | Analysis was performed on the full analysis set (all patients for whom at least baseline data were recorded) and all available data at each visit. | Posted | Number | participants | time 0 (Baseline), month 3, and every 3 months thereafter until disease progression or up to 24 months, whichever came first |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Primary | Treatment Patterns for Prostate Cancer Treatments: Number of Participants at Each Visit Who Took Lucrin/Lucrin Tridepot, Luteinizing Hormone-releasing Hormone (LHRH) Agonists, Anti-androgens, or Other Drug Treatments, or Who Had Surgery or Radiotherapy. | Prostate cancer treatment for all participants is summarized by the number of participants at each visit who took any Lucrin/Lucrin Tridepot, LHRH agonist, anti-androgens, or other drug treatments, or who had any type of surgery or radiotherapy (external radiation or brachytherapy). | Analysis was performed on the full analysis set (all patients for whom at least baseline data were recorded) and all available data at each visit. | Posted | Number | participants | time 0 (Baseline), month 3, and every 3 months until disease progression or up to 24 months, whichever came first |
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| Secondary | Safety Parameter: Number of Participants Reporting Serious Adverse Events (SAEs) | The number of participants experiencing a serious adverse event during the course of the study is summarized. See the Reported Adverse Event section for details. | Analysis was performed on the full analysis set consisting of all patients for whom at least baseline data were recorded. | Posted | Number | participants | Baseline to disease progression or 24 months, whichever came first |
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| Secondary | Epidemiological Data: Mean Weight | The mean weight of all participants at baseline is provided. | Analysis was performed on the full analysis set consisting of all patients for whom at least baseline data were recorded. Data for age was available for 2,691 patients and for weight for 2,116 patients. | Posted | Mean | Standard Deviation | kg | at time 0 (Baseline) |
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| Secondary | Epidemiological Data: Mean Age | The mean age of all participants at baseline is provided. | Analysis was performed on the full analysis set consisting of all patients for whom at least baseline data were recorded. Data for age was available for 2,691 patients and for weight for 2,116 patients. | Posted | Mean | Standard Deviation | years | at time 0 (Baseline) |
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| Secondary | Epidemiological Data: Race | The number of participants by race at baseline is presented. | Analysis was performed on the full analysis set consisting of all patients for whom at least baseline data were recorded. Data for race was available for 2,217 patients. | Posted | Number | participants | at time 0 (Baseline) |
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| Secondary | Epidemiological Data: Tumor Staging - Among Participants With a Positive Biopsy, the Number of Participants With Adenocarcinoma Tissue or Other Tissues Recorded for the Positive Biopsy. | Among those participants with a positive biopsy at baseline, the number of participants with adenocarcinoma tissue or other tissue type is summarized. | Analysis was performed on the full analysis set (all patients for whom at least baseline data were recorded) and all available data. | Posted | Number | participants | at time 0 (Baseline) |
|
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| Secondary | Epidemiological Data: PSA at Baseline | The median, minimum, and maximum PSA values in ng/mL at baseline are provided. The mean PSA at baseline is reported in the Primary Outcome Measure section above. | Analysis was performed on the full analysis set consisting of all patients for whom at least baseline data were recorded. Data for PSA at baseline was available for 2,532 patients. | Posted | Median | Full Range | ng/mL | at time 0 (Baseline) |
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| Secondary | Epidemiological Data: Tumor Staging (Positive or Negative) Via a Rectal Examination, Prostate Biopsy, Echograph, or Magnetic Resonance Imaging (MRI) Test. | The number of participants at baseline who were positive or negative for tumors via a rectal examination, prostate biopsy, echograph of the hyperechogenic zones, or MRI are provided. | Analysis was performed on the full analysis set (all patients for whom at least baseline data were recorded) and all available data. | Posted | Number | participants | at time 0 (Baseline) |
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| Secondary | Epidemiological Data: the Number of Participants With Tumor Stages T0, T1, T2, T3, and T4. | The number of participants with tumor stages T0, T1, T2, T3, and T4 as reported by the physician or pathologist is summarized. T0: no evidence of primary tumor. T1: histologic tumor confined to prostate; clinically unapparent tumor, undetectable by digital rectal examination or by ultrasound. T2: tumor is confined to prostrate and can be detected by digital rectal examination. T3: tumor extends through the prostate capsule but has not spread to other organs. T4: tumor has invaded adjacent structures/organs other than seminal vesicles. | Analysis was performed on the full analysis set (all patients for whom at least baseline data were recorded) and all available data. | Posted | Number | participants | at time 0 (Baseline) |
|
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| Secondary | Epidemiological Data: Node Staging - the Number of Participants With a Positive or Negative Computerized Tomography (CT) Scan or Magnetic Resonance Imaging (MRI) Test | In this case, a CT or MRI is considered positive when lymph nodes are detectable. A CT or MRI is considered negative when lymph nodes are not detectable. | Analysis was performed on the full analysis set (all patients for whom at least baseline data were recorded) and all available data. | Posted | Number | participants | at time 0 (Baseline) |
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| Secondary | Epidemiological Data: Node Staging - the Number of Participants With a N0 or N1 Stage at Baseline. | N0: tumor cells absent from regional lymph nodes. N1: regional lymph node metastasis present. | Analysis was performed on the full analysis set (all patients for whom at least baseline data were recorded) and all available data. | Posted | Number | participants | at time 0 (Baseline) |
|
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| Secondary | Epidemiological Data: Bone Scan at Baseline | The number of participants at baseline with a positive or negative bone scan was summarized. Determination of bone scan status was based on the interpretation of the Investigator or radiologist. | Analysis was performed on the full analysis set (all patients for whom at least baseline data were recorded) and all available data. | Posted | Number | participants | at time 0 (Baseline) |
|
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| Secondary | Epidemiological Data: Metastasis Staging (M0 or M1) at Baseline | The number of participants at baseline reported to be in metastasis stage M0 or M1 is summarized. M0: no distant metastasis. M1: metastasis to distant organs beyond regional lymph nodes. | Analysis was performed on the full analysis set (all patients for whom at least baseline data were recorded) and all available data. | Posted | Number | participants | at time 0 (Baseline) |
|
|
All adverse events that occurred during the course of the study were reported and followed to a satisfactory conclusion.
Not provided
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 | Advanced Prostate Cancer Participants | Participants with advanced prostate cancer treated with Lucrin /Lucrin- Tri-depot (leuprolide) or any other treatment with local reimbursement guidelines. No Baseline data was available for 3 patients who were thus excluded from all analyses. | 121 | 2,714 | 8 | 2,714 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA (14.0) | Non-systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA (14.0) | Non-systematic Assessment |
| |
| Acute myocardial infarction | Cardiac disorders | MedDRA (14.0) | Non-systematic Assessment |
| |
| Aortic valve stenosis | Cardiac disorders | MedDRA (14.0) | Non-systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA (14.0) | Non-systematic Assessment |
| |
| Cardiac arrest | Cardiac disorders | MedDRA (14.0) | Non-systematic Assessment |
| |
| Cardiac disorder | Cardiac disorders | MedDRA (14.0) | Non-systematic Assessment |
| |
| Cardiac failure | Cardiac disorders | MedDRA (14.0) | Non-systematic Assessment |
| |
| Cardiac failure chronic | Cardiac disorders | MedDRA (14.0) | Non-systematic Assessment |
| |
| Cardio-respiratory arrest | Cardiac disorders | MedDRA (14.0) | Non-systematic Assessment |
| |
| Cardiogenic shock | Cardiac disorders | MedDRA (14.0) | Non-systematic Assessment |
| |
| Cardiomyopathy | Cardiac disorders | MedDRA (14.0) | Non-systematic Assessment |
| |
| Cardiopulmonary failure | Cardiac disorders | MedDRA (14.0) | Non-systematic Assessment |
| |
| Cardiovascular disorder | Cardiac disorders | MedDRA (14.0) | Non-systematic Assessment |
| |
| Myocardial infarction | Cardiac disorders | MedDRA (14.0) | Non-systematic Assessment |
| |
| Ventricular tachycardia | Cardiac disorders | MedDRA (14.0) | Non-systematic Assessment |
| |
| Abdominal discomfort | Gastrointestinal disorders | MedDRA (14.0) | Non-systematic Assessment |
| |
| Dysphagia | Gastrointestinal disorders | MedDRA (14.0) | Non-systematic Assessment |
| |
| Enterovesical fistula | Gastrointestinal disorders | MedDRA (14.0) | Non-systematic Assessment |
| |
| Large intestine perforation | Gastrointestinal disorders | MedDRA (14.0) | Non-systematic Assessment |
| |
| Peritonitis | Gastrointestinal disorders | MedDRA (14.0) | Non-systematic Assessment |
| |
| Death | General disorders | MedDRA (14.0) | Non-systematic Assessment |
| |
| Disease progression | General disorders | MedDRA (14.0) | Non-systematic Assessment |
| |
| Fatigue | General disorders | MedDRA (14.0) | Non-systematic Assessment |
| |
| General physical health deterioration | General disorders | MedDRA (14.0) | Non-systematic Assessment |
| |
| Multi-organ failure | General disorders | MedDRA (14.0) | Non-systematic Assessment |
| |
| Terminal state | General disorders | MedDRA (14.0) | Non-systematic Assessment |
| |
| Therapeutic response decreased | General disorders | MedDRA (14.0) | Non-systematic Assessment |
| |
| Cholecystitis acute | Hepatobiliary disorders | MedDRA (14.0) | Non-systematic Assessment |
| |
| Hepatic failure | Hepatobiliary disorders | MedDRA (14.0) | Non-systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA (14.0) | Non-systematic Assessment |
| |
| Bronchopneumonia | Infections and infestations | MedDRA (14.0) | Non-systematic Assessment |
| |
| Lung infection | Infections and infestations | MedDRA (14.0) | Non-systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA (14.0) | Non-systematic Assessment |
| |
| Pulmonary sepsis | Infections and infestations | MedDRA (14.0) | Non-systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA (14.0) | Non-systematic Assessment |
| |
| Superinfection | Infections and infestations | MedDRA (14.0) | Non-systematic Assessment |
| |
| Accident | Injury, poisoning and procedural complications | MedDRA (14.0) | Non-systematic Assessment |
| |
| Subdural haematoma | Injury, poisoning and procedural complications | MedDRA (14.0) | Non-systematic Assessment |
| |
| Cardiac enzymes increased | Investigations | MedDRA (14.0) | Non-systematic Assessment |
| |
| Prostatic specific antigen abnormal | Investigations | MedDRA (14.0) | Non-systematic Assessment |
| |
| Cachexia | Metabolism and nutrition disorders | MedDRA (14.0) | Non-systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA (14.0) | Non-systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA (14.0) | Non-systematic Assessment |
| |
| Diabetes mellitus | Metabolism and nutrition disorders | MedDRA (14.0) | Non-systematic Assessment |
| |
| Diet refusal | Metabolism and nutrition disorders | MedDRA (14.0) | Non-systematic Assessment |
| |
| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA (14.0) | Non-systematic Assessment |
| |
| Lactic acidosis | Metabolism and nutrition disorders | MedDRA (14.0) | Non-systematic Assessment |
| |
| Bone disorder | Musculoskeletal and connective tissue disorders | MedDRA (14.0) | Non-systematic Assessment |
| |
| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA (14.0) | Non-systematic Assessment |
| |
| Pathological fracture | Musculoskeletal and connective tissue disorders | MedDRA (14.0) | Non-systematic Assessment |
| |
| Bladder cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (14.0) | Non-systematic Assessment |
| |
| Breast cancer male | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (14.0) | Non-systematic Assessment |
| |
| Colon cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (14.0) | Non-systematic Assessment |
| |
| Lung neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (14.0) | Non-systematic Assessment |
| |
| Lung neoplasm malignant | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (14.0) | Non-systematic Assessment |
| |
| Metastases to bladder | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (14.0) | Non-systematic Assessment |
| |
| Metastases to bone | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (14.0) | Non-systematic Assessment |
| |
| Metastases to central nervous system | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (14.0) | Non-systematic Assessment |
| |
| Metastases to liver | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (14.0) | Non-systematic Assessment |
| |
| Metastases to lung | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (14.0) | Non-systematic Assessment |
| |
| Metastases to lymph nodes | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (14.0) | Non-systematic Assessment |
| |
| Metastasis | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (14.0) | Non-systematic Assessment |
| |
| Metastatic neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (14.0) | Non-systematic Assessment |
| |
| Neoplasm malignant | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (14.0) | Non-systematic Assessment |
| |
| Pancreatic carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (14.0) | Non-systematic Assessment |
| |
| Prostate cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (14.0) | Non-systematic Assessment |
| |
| Prostate cancer metastatic | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (14.0) | Non-systematic Assessment |
| |
| Rectal cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (14.0) | Non-systematic Assessment |
| |
| Small cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (14.0) | Non-systematic Assessment |
| |
| Ureteral neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (14.0) | Non-systematic Assessment |
| |
| Cerebral haemorrhage | Nervous system disorders | MedDRA (14.0) | Non-systematic Assessment |
| |
| Cerebrovascular accident | Nervous system disorders | MedDRA (14.0) | Non-systematic Assessment |
| |
| Coma | Nervous system disorders | MedDRA (14.0) | Non-systematic Assessment |
| |
| Dementia | Nervous system disorders | MedDRA (14.0) | Non-systematic Assessment |
| |
| Dementia Alzheimer's type | Nervous system disorders | MedDRA (14.0) | Non-systematic Assessment |
| |
| Depressed level of consciousness | Nervous system disorders | MedDRA (14.0) | Non-systematic Assessment |
| |
| Haemorrhagic stroke | Nervous system disorders | MedDRA (14.0) | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA (14.0) | Non-systematic Assessment |
| |
| Parkinson's disease | Nervous system disorders | MedDRA (14.0) | Non-systematic Assessment |
| |
| Thrombotic stroke | Nervous system disorders | MedDRA (14.0) | Non-systematic Assessment |
| |
| Transient ischaemic attack | Nervous system disorders | MedDRA (14.0) | Non-systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA (14.0) | Non-systematic Assessment |
| |
| Anuria | Renal and urinary disorders | MedDRA (14.0) | Non-systematic Assessment |
| |
| Azotaemia | Renal and urinary disorders | MedDRA (14.0) | Non-systematic Assessment |
| |
| Dysuria | Renal and urinary disorders | MedDRA (14.0) | Non-systematic Assessment |
| |
| Hydronephrosis | Renal and urinary disorders | MedDRA (14.0) | Non-systematic Assessment |
| |
| Renal failure | Renal and urinary disorders | MedDRA (14.0) | Non-systematic Assessment |
| |
| Renal failure acute | Renal and urinary disorders | MedDRA (14.0) | Non-systematic Assessment |
| |
| Acute respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA (14.0) | Non-systematic Assessment |
| |
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA (14.0) | Non-systematic Assessment |
| |
| Emphysema | Respiratory, thoracic and mediastinal disorders | MedDRA (14.0) | Non-systematic Assessment |
| |
| Hypercapnia | Respiratory, thoracic and mediastinal disorders | MedDRA (14.0) | Non-systematic Assessment |
| |
| Hyperventilation | Respiratory, thoracic and mediastinal disorders | MedDRA (14.0) | Non-systematic Assessment |
| |
| Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA (14.0) | Non-systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA (14.0) | Non-systematic Assessment |
| |
| Pulmonary oedema | Respiratory, thoracic and mediastinal disorders | MedDRA (14.0) | Non-systematic Assessment |
| |
| Respiratory acidosis | Respiratory, thoracic and mediastinal disorders | MedDRA (14.0) | Non-systematic Assessment |
| |
| Respiratory arrest | Respiratory, thoracic and mediastinal disorders | MedDRA (14.0) | Non-systematic Assessment |
| |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA (14.0) | Non-systematic Assessment |
| |
| Bladder catheterisation | Surgical and medical procedures | MedDRA (14.0) | Non-systematic Assessment |
| |
| Cardiac operation | Surgical and medical procedures | MedDRA (14.0) | Non-systematic Assessment |
| |
| Angiopathy | Vascular disorders | MedDRA (14.0) | Non-systematic Assessment |
| |
| Embolism | Vascular disorders | MedDRA (14.0) | Non-systematic Assessment |
| |
| Infarction | Vascular disorders | MedDRA (14.0) | Non-systematic Assessment |
| |
| Thrombophlebitis | Vascular disorders | MedDRA (14.0) | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Porphyria non-acute | Congenital, familial and genetic disorders | MedDRA (14.0) | Non-systematic Assessment |
| |
| Fatigue | General disorders | MedDRA (14.0) | Non-systematic Assessment |
| |
| Osteopenia | Musculoskeletal and connective tissue disorders | MedDRA (14.0) | Non-systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA (14.0) | Non-systematic Assessment |
| |
| Urinary retention | Renal and urinary disorders | MedDRA (14.0) | Non-systematic Assessment |
| |
| Gynaecomastia | Reproductive system and breast disorders | MedDRA (14.0) | Non-systematic Assessment |
| |
| Hot flush | Vascular disorders | MedDRA (14.0) | Non-systematic Assessment |
|
Abbott 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. Abbott 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 Abbott needs to secure patent or proprietary protection.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Global Medical Services | 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 |
Not provided
Not provided
| ID | Term |
|---|---|
| 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
| Local tumor |
|
| Single metastases |
|
| Multiple metastases in 1 organ |
|
| Multiple metastases in multiple organs |
|
| OG003 | Advanced Prostate Cancer Participants at Month 9 | Participants with advanced prostate cancer treated with Lucrin /Lucrin- Tri-depot (leuprolide) or any other treatment with local reimbursement guidelines that had had a value recorded at Month 9. |
| OG004 | Advanced Prostate Cancer Participants at Month 12 | Participants with advanced prostate cancer treated with Lucrin /Lucrin- Tri-depot (leuprolide) or any other treatment with local reimbursement guidelines that had a value recorded at Month 12 |
| OG005 | Advanced Prostate Cancer Participants at Month 15 | Participants with advanced prostate cancer treated with Lucrin /Lucrin- Tri-depot (leuprolide) or any other treatment with local reimbursement guidelines that had a value recorded at Month 15. |
| OG006 | Advanced Prostate Cancer Participants at Month 18 | Participants with advanced prostate cancer treated with Lucrin /Lucrin- Tri-depot (leuprolide) or any other treatment with local reimbursement guidelines that had a value recorded at Month 18. |
| OG007 | Advanced Prostate Cancer Participants at Month 21 | Participants with advanced prostate cancer treated with Lucrin /Lucrin- Tri-depot (leuprolide) or any other treatment with local reimbursement guidelines that had a value recorded at Month 21. |
| OG008 | Advanced Prostate Cancer Participants at Month 24 | Participants with advanced prostate cancer treated with Lucrin /Lucrin- Tri-depot (leuprolide) or any other treatment with local reimbursement guidelines that had a value recorded at Month 24. |
| OG009 | Advanced Prostate Cancer Participants - Last Available Record | Participants with advanced prostate cancer treated with Lucrin /Lucrin- Tri-depot (leuprolide) or any other treatment with local reimbursement guidelines that had any final value recorded. |
|
|
Participants with advanced prostate cancer treated with Lucrin /Lucrin- Tri-depot (leuprolide) or any other treatment with local reimbursement guidelines that had had a value recorded at Month 9. |
| OG003 | Advanced Prostate Cancer Participants at Month 12 | Participants with advanced prostate cancer treated with Lucrin /Lucrin- Tri-depot (leuprolide) or any other treatment with local reimbursement guidelines that had a value recorded at Month 12 |
| OG004 | Advanced Prostate Cancer Participants at Month 15 | Participants with advanced prostate cancer treated with Lucrin /Lucrin- Tri-depot (leuprolide) or any other treatment with local reimbursement guidelines that had a value recorded at Month 15. |
| OG005 | Advanced Prostate Cancer Participants at Month 18 | Participants with advanced prostate cancer treated with Lucrin /Lucrin- Tri-depot (leuprolide) or any other treatment with local reimbursement guidelines that had a value recorded at Month 18. |
| OG006 | Advanced Prostate Cancer Participants at Month 21 | Participants with advanced prostate cancer treated with Lucrin /Lucrin- Tri-depot (leuprolide) or any other treatment with local reimbursement guidelines that had a value recorded at Month 21. |
| OG007 | Advanced Prostate Cancer Participants at Month 24 | Participants with advanced prostate cancer treated with Lucrin /Lucrin- Tri-depot (leuprolide) or any other treatment with local reimbursement guidelines that had a value recorded at Month 24. |
| OG008 | Advanced Prostate Cancer Participants - Last Available Record | Participants with advanced prostate cancer treated with Lucrin /Lucrin- Tri-depot (leuprolide) or any other treatment with local reimbursement guidelines that had any final value recorded. |
|
|
| Advanced Prostate Cancer Participants at Month 6 |
Participants with advanced prostate cancer treated with Lucrin /Lucrin- Tri-depot (leuprolide) or any other treatment with local reimbursement guidelines that had a value recorded at Month 6. |
| OG003 | Advanced Prostate Cancer Participants at Month 9 | Participants with advanced prostate cancer treated with Lucrin /Lucrin- Tri-depot (leuprolide) or any other treatment with local reimbursement guidelines that had had a value recorded at Month 9. |
| OG004 | Advanced Prostate Cancer Participants at Month 12 | Participants with advanced prostate cancer treated with Lucrin /Lucrin- Tri-depot (leuprolide) or any other treatment with local reimbursement guidelines that had a value recorded at Month 12 |
| OG005 | Advanced Prostate Cancer Participants at Month 15 | Participants with advanced prostate cancer treated with Lucrin /Lucrin- Tri-depot (leuprolide) or any other treatment with local reimbursement guidelines that had a value recorded at Month 15. |
| OG006 | Advanced Prostate Cancer Participants at Month 18 | Participants with advanced prostate cancer treated with Lucrin /Lucrin- Tri-depot (leuprolide) or any other treatment with local reimbursement guidelines that had a value recorded at Month 18. |
| OG007 | Advanced Prostate Cancer Participants at Month 21 | Participants with advanced prostate cancer treated with Lucrin /Lucrin- Tri-depot (leuprolide) or any other treatment with local reimbursement guidelines that had a value recorded at Month 21. |
| OG008 | Advanced Prostate Cancer Participants at Month 24 | Participants with advanced prostate cancer treated with Lucrin /Lucrin- Tri-depot (leuprolide) or any other treatment with local reimbursement guidelines that had a value recorded at Month 24. |
| OG009 | Advanced Prostate Cancer Participants - Last Available Record | Participants with advanced prostate cancer treated with Lucrin /Lucrin- Tri-depot (leuprolide) or any other treatment with local reimbursement guidelines that had any final value recorded. |
|
|
| Advanced Prostate Cancer Participants at Month 6 |
Participants with advanced prostate cancer treated with Lucrin /Lucrin- Tri-depot (leuprolide) or any other treatment with local reimbursement guidelines that had a value recorded at Month 6. |
| OG003 | Advanced Prostate Cancer Participants at Month 9 | Participants with advanced prostate cancer treated with Lucrin /Lucrin- Tri-depot (leuprolide) or any other treatment with local reimbursement guidelines that had had a value recorded at Month 9. |
| OG004 | Advanced Prostate Cancer Participants at Month 12 | Participants with advanced prostate cancer treated with Lucrin /Lucrin- Tri-depot (leuprolide) or any other treatment with local reimbursement guidelines that had a value recorded at Month 12 |
| OG005 | Advanced Prostate Cancer Participants at Month 15 | Participants with advanced prostate cancer treated with Lucrin /Lucrin- Tri-depot (leuprolide) or any other treatment with local reimbursement guidelines that had a value recorded at Month 15. |
| OG006 | Advanced Prostate Cancer Participants at Month 18 | Participants with advanced prostate cancer treated with Lucrin /Lucrin- Tri-depot (leuprolide) or any other treatment with local reimbursement guidelines that had a value recorded at Month 18. |
| OG007 | Advanced Prostate Cancer Participants at Month 21 | Participants with advanced prostate cancer treated with Lucrin /Lucrin- Tri-depot (leuprolide) or any other treatment with local reimbursement guidelines that had a value recorded at Month 21. |
| OG008 | Advanced Prostate Cancer Participants at Month 24 | Participants with advanced prostate cancer treated with Lucrin /Lucrin- Tri-depot (leuprolide) or any other treatment with local reimbursement guidelines that had a value recorded at Month 24. |
| OG009 | Advanced Prostate Cancer Participants - Use at Any Visit | Participants with advanced prostate cancer treated with Lucrin /Lucrin- Tri-depot (leuprolide) or any other treatment with local reimbursement guidelines that had used any of the treatments at any visit. |
|
|
|
|
|
|
|
|
| OG003 | Advanced Prostate Cancer Participants - MRI | Participants with advanced prostate cancer treated with Lucrin /Lucrin- Tri-depot (leuprolide) or any other treatment with local reimbursement guidelines who had tumor staging assessed via MRI. |
|
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|
|
|
|
|