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Study to Document Treatment Patterns and to Evaluate Leuprolide and Alternative Therapeutic Approaches to the Treatments of Advanced Prostate Cancer

Sponsor
Abbott (Industry)
Overall Status
Completed
CT.gov ID
NCT01081873
Collaborator
(none)
2,717
Enrollment
135
Locations
78
Duration (Months)
20.1
Patients Per Site
0.3
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: leuprolide (Lucrin/Lucrin-Tri-depot)

Study Design

Study Type:
Observational
Actual Enrollment :
2717 participants
Observational Model:
Case-Only
Time Perspective:
Prospective
Official Title:
A Post-Marketing Observational Study to Document Treatment Patterns and to Evaluate Leuprolide and Alternative Therapeutic Approaches to the Treatment of Advanced Prostate Cancer
Study Start Date :
Jun 1, 2004
Actual Primary Completion Date :
Dec 1, 2010
Actual Study Completion Date :
Dec 1, 2010

Arms and Interventions

Arm Intervention/Treatment
Advanced prostate cancer participants

Participants with advanced prostate cancer treated with Lucrin /Lucrin- Tri-depot (leuprolide) or any other treatment within local reimbursement guidelines.

Drug: leuprolide (Lucrin/Lucrin-Tri-depot)
Subcutaneous or intramuscular administration for all participants
Other Names:
  • Lucrin
  • Lucrin-Tri-depot

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Effectiveness Parameter for Staging of Prostate Cancer: Metastases at Each Visit [time 0 (Baseline), month 3, and every 3 months until disease progression or up to 24 months, whichever came first]

      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.

    2. Effectiveness Parameter for Screening or Recurrence of Prostate Cancer: Mean Prostate-specific Antigen (PSA) at Each Visit [time 0 (Baseline), month 3, and every 3 months until disease progression or up to 24 months, whichever came first]

      The mean PSA in ng/mL to screen and assess for the recurrence of prostate cancer at each visit is presented.

    3. Effectiveness Parameter: the Number of Participants With a Complete or Partial Response, Stable Disease, or Progressive Disease Following Treatment at Each Visit [month 3, and every 3 months until disease progression or up to 24 months, whichever came first]

      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.

    4. 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 [time 0 (Baseline), month 3, and every 3 months thereafter until disease progression or up to 24 months, whichever came first]

      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.

    5. 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. [time 0 (Baseline), month 3, and every 3 months until disease progression or up to 24 months, whichever came first]

      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).

    Secondary Outcome Measures

    1. Safety Parameter: Number of Participants Reporting Serious Adverse Events (SAEs) [Baseline to disease progression or 24 months, whichever came first]

      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.

    2. Epidemiological Data: Mean Weight [at time 0 (Baseline)]

      The mean weight of all participants at baseline is provided.

    3. Epidemiological Data: Mean Age [at time 0 (Baseline)]

      The mean age of all participants at baseline is provided.

    4. Epidemiological Data: Race [at time 0 (Baseline)]

      The number of participants by race at baseline is presented.

    5. 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. [at time 0 (Baseline)]

      Among those participants with a positive biopsy at baseline, the number of participants with adenocarcinoma tissue or other tissue type is summarized.

    6. Epidemiological Data: PSA at Baseline [at time 0 (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.

    7. Epidemiological Data: Tumor Staging (Positive or Negative) Via a Rectal Examination, Prostate Biopsy, Echograph, or Magnetic Resonance Imaging (MRI) Test. [at time 0 (Baseline)]

      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.

    8. Epidemiological Data: the Number of Participants With Tumor Stages T0, T1, T2, T3, and T4. [at time 0 (Baseline)]

      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.

    9. Epidemiological Data: Node Staging - the Number of Participants With a Positive or Negative Computerized Tomography (CT) Scan or Magnetic Resonance Imaging (MRI) Test [at time 0 (Baseline)]

      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.

    10. Epidemiological Data: Node Staging - the Number of Participants With a N0 or N1 Stage at Baseline. [at time 0 (Baseline)]

      N0: tumor cells absent from regional lymph nodes. N1: regional lymph node metastasis present.

    11. Epidemiological Data: Bone Scan at Baseline [at time 0 (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.

    12. Epidemiological Data: Metastasis Staging (M0 or M1) at Baseline [at time 0 (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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    Male
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Patients with advanced prostate cancer who have been prescribed Lucrin/ Lucrin-Tri-depot or any other treatment with local reimbursement guidelines; Patients willing to consent to data being collected and provided to Abbott Laboratories.
    Exclusion Criteria:
    • Contraindications according to the Summary of Product Characteristics (SPC).

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Site Reference ID/Investigator# 31196 Aartselaar Belgium B-2630
    2 Site Reference ID/Investigator# 31237 Afsnee Belgium B-9051
    3 Site Reference ID/Investigator# 31121 Alken Belgium B-3570
    4 Site Reference ID/Investigator# 31170 Antwerpen Belgium B-2018
    5 Site Reference ID/Investigator# 31194 Antwerpen Belgium B-2018
    6 Site Reference ID/Investigator# 4872 Antwerp Belgium B-2020
    7 Site Reference ID/Investigator# 31186 Antwerp Belgium B-2050
    8 Site Reference ID/Investigator# 31141 Arlon Belgium B-6700
    9 Site Reference ID/Investigator# 31199 Arlon Belgium B-6700
    10 Site Reference ID/Investigator# 31247 Ath Belgium B-7804
    11 Site Reference ID/Investigator# 31190 Baulers Belgium B-1401
    12 Site Reference ID/Investigator# 31210 Beerse Belgium B-2340
    13 Site Reference ID/Investigator# 31171 Berchem Belgium B-2600
    14 Site Reference ID/Investigator# 31137 Berlaar Belgium B-2590
    15 Site Reference ID/Investigator# 31204 Beveren Belgium B-8800
    16 Site Reference ID/Investigator# 31184 Boutersem Belgium B-3370
    17 Site Reference ID/Investigator# 31205 Braine-Le-Chateau Belgium B-1440
    18 Site Reference ID/Investigator# 31217 Brasschaat Belgium B-2930
    19 Site Reference ID/Investigator# 31133 Bruges Belgium B-8310
    20 Site Reference ID/Investigator# 31135 Bruges Belgium B-8310
    21 Site Reference ID/Investigator# 31134 Brugge Belgium B-8310
    22 Site Reference ID/Investigator# 31233 Brussels Belgium B-1000
    23 Site Reference ID/Investigator# 31252 Brussels Belgium B-1160
    24 Site Reference ID/Investigator# 31232 Brussels Belgium B-1200
    25 Site Reference ID/Investigator# 31161 Bruxelles Belgium B-1020
    26 Site Reference ID/Investigator# 31223 Bruxelles Belgium B-1030
    27 Site Reference ID/Investigator# 31152 Bruxelles Belgium B-1050
    28 Site Reference ID/Investigator# 31251 Bruxelles Belgium B-1081
    29 Site Reference ID/Investigator# 31178 Bruxelles Belgium B-1083
    30 Site Reference ID/Investigator# 31236 Bruxelles Belgium B-1090
    31 Site Reference ID/Investigator# 31117 Bruxelles Belgium B-1180
    32 Site Reference ID/Investigator# 31203 Bruxelles Belgium B-1180
    33 Site Reference ID/Investigator# 31200 Bruxelles Belgium B-1853
    34 Site Reference ID/Investigator# 31129 Court St. Etienne Belgium B-1490
    35 Site Reference ID/Investigator# 31244 Cuesmes Belgium B-7033
    36 Site Reference ID/Investigator# 31208 Damme Belgium B-8340
    37 Site Reference ID/Investigator# 31155 Dendermonde Belgium B-9200
    38 Site Reference ID/Investigator# 31197 Dendermonde Belgium B-9200
    39 Site Reference ID/Investigator# 31189 Diest Belgium B-3290
    40 Site Reference ID/Investigator# 31126 Dilbeek Belgium B-1700
    41 Site Reference ID/Investigator# 31116 Dworp Belgium B-1653
    42 Site Reference ID/Investigator# 31160 Dworp Belgium B-1653
    43 Site Reference ID/Investigator# 31179 Elingen Belgium B-1671
    44 Site Reference ID/Investigator# 31249 Embourg Belgium B-4053
    45 Site Reference ID/Investigator# 31166 Erpent Belgium B-5101
    46 Site Reference ID/Investigator# 31192 Esneux Belgium B-4130
    47 Site Reference ID/Investigator# 31188 Falmagne Belgium B-5500
    48 Site Reference ID/Investigator# 31195 Feluy Belgium B-7181
    49 Site Reference ID/Investigator# 31250 Floreffe Belgium B-5150
    50 Site Reference ID/Investigator# 31173 Genk-Waterschei Belgium B-3600
    51 Site Reference ID/Investigator# 31183 Genk Belgium B-3600
    52 Site Reference ID/Investigator# 31228 Gent Belgium B-9000
    53 Site Reference ID/Investigator# 46502 Gent Belgium B-9000
    54 Site Reference ID/Investigator# 31132 Gouy-Les-Pietons Belgium B-6181
    55 Site Reference ID/Investigator# 31124 Halle Belgium B-1500
    56 Site Reference ID/Investigator# 31191 Hamme Belgium B-9220
    57 Site Reference ID/Investigator# 31234 Hasselt Belgium B-3510
    58 Site Reference ID/Investigator# 31227 Heusy Belgium B-4802
    59 Site Reference ID/Investigator# 31212 Hofstade Belgium B-1981
    60 Site Reference ID/Investigator# 31143 Hove Belgium B-2540
    61 Site Reference ID/Investigator# 31226 Huy Belgium B-4500
    62 Site Reference ID/Investigator# 31119 Izegem Belgium B-8870
    63 Site Reference ID/Investigator# 31181 Izegem Belgium B-8870
    64 Site Reference ID/Investigator# 31149 Knokke Belgium B-8300
    65 Site Reference ID/Investigator# 31177 Koksijde Belgium B-8670
    66 Site Reference ID/Investigator# 31253 Kortrijk Belgium B-8500
    67 Site Reference ID/Investigator# 31130 Lasne Belgium B-1380
    68 Site Reference ID/Investigator# 31159 Lennik Belgium B-1750
    69 Site Reference ID/Investigator# 31123 Leper Belgium B-8900
    70 Site Reference ID/Investigator# 31241 Leper Belgium B-8900
    71 Site Reference ID/Investigator# 31255 Lesves Belgium B-1380
    72 Site Reference ID/Investigator# 31259 Leuven Belgium 3000
    73 Site Reference ID/Investigator# 31219 Libramont Belgium B-6800
    74 Site Reference ID/Investigator# 31128 Liege Belgium B-4000
    75 Site Reference ID/Investigator# 31144 Liege Belgium B-4000
    76 Site Reference ID/Investigator# 31185 Liege Belgium B-4000
    77 Site Reference ID/Investigator# 31207 Liege Belgium B-4000
    78 Site Reference ID/Investigator# 31245 Liege Belgium B-4000
    79 Site Reference ID/Investigator# 31224 Lier Belgium B2400
    80 Site Reference ID/Investigator# 31243 Lommel Belgium B-3920
    81 Site Reference ID/Investigator# 31225 Marcinelle Belgium B-6001
    82 Site Reference ID/Investigator# 31139 Marcq Belgium B-7850
    83 Site Reference ID/Investigator# 31206 Mol Belgium B-2400
    84 Site Reference ID/Investigator# 31153 Mons Belgium B-7000
    85 Site Reference ID/Investigator# 31257 Mons Belgium B-7000
    86 Site Reference ID/Investigator# 31140 Mont-sur-Marchienne Belgium B-6032
    87 Site Reference ID/Investigator# 31222 Mortsel Belgium B2640
    88 Site Reference ID/Investigator# 31164 Namur Belgium B-5000
    89 Site Reference ID/Investigator# 31258 Nivelles Belgium B-1400
    90 Site Reference ID/Investigator# 31218 Oordegem Belgium B-9340
    91 Site Reference ID/Investigator# 31214 Oostende Belgium B-8400
    92 Site Reference ID/Investigator# 31242 Oostende Belgium B-8400
    93 Site Reference ID/Investigator# 31156 Oosterzele Belgium B-9860
    94 Site Reference ID/Investigator# 31131 Ottignies Belgium B-1340
    95 Site Reference ID/Investigator# 31163 Oudenaarde Belgium B-9700
    96 Site Reference ID/Investigator# 31125 Overijse Belgium B-3090
    97 Site Reference ID/Investigator# 31198 Pollinkhove Belgium B-8647
    98 Site Reference ID/Investigator# 31229 Ragnies Belgium B-6532
    99 Site Reference ID/Investigator# 31138 Rijmenam Belgium B-2820
    100 Site Reference ID/Investigator# 31122 Roeselare Belgium B-8800
    101 Site Reference ID/Investigator# 31174 Roeslare Belgium B-8800
    102 Site Reference ID/Investigator# 31136 Rotselaar Belgium B-3110
    103 Site Reference ID/Investigator# 31180 Rumbeke Belgium B-8800
    104 Site Reference ID/Investigator# 31147 S. Gravenwezel Belgium B-2970
    105 Site Reference ID/Investigator# 31215 Saint Ghislain Belgium B-7330
    106 Site Reference ID/Investigator# 31176 Saintes Belgium B-1480
    107 Site Reference ID/Investigator# 31168 Schilde Belgium B-2970
    108 Site Reference ID/Investigator# 31220 Schoten Belgium B-2900
    109 Site Reference ID/Investigator# 31238 Schoten Belgium B-2900
    110 Site Reference ID/Investigator# 31142 Seneffe Belgium B-7180
    111 Site Reference ID/Investigator# 31158 Seraing Belgium B-4100
    112 Site Reference ID/Investigator# 31246 Silly Belgium B-7830
    113 Site Reference ID/Investigator# 31240 Sint Niklaas Belgium B-9100
    114 Site Reference ID/Investigator# 31120 Sint Truiden Belgium B-3800
    115 Site Reference ID/Investigator# 31230 Sint-Genesius-Rode Belgium B-1640
    116 Site Reference ID/Investigator# 31213 Sirault Belgium B-7332
    117 Site Reference ID/Investigator# 31150 St Denis Belgium B-7034
    118 Site Reference ID/Investigator# 31157 St. Truiden Belgium B-3800
    119 Site Reference ID/Investigator# 31182 Tielt Belgium B-8700
    120 Site Reference ID/Investigator# 31248 Tilff Belgium B-4130
    121 Site Reference ID/Investigator# 31151 Tournai Belgium B-7500
    122 Site Reference ID/Investigator# 31146 Tremelo Belgium B-3120
    123 Site Reference ID/Investigator# 31254 Uccle Belgium B-1180
    124 Site Reference ID/Investigator# 31256 Uccle Belgium B-1180
    125 Site Reference ID/Investigator# 31165 Veerle Belgium B-2431
    126 Site Reference ID/Investigator# 31193 Villers-Saint-Simeon Belgium B-4453
    127 Site Reference ID/Investigator# 31175 Wanze Belgium B-4520
    128 Site Reference ID/Investigator# 31145 Waregem Belgium B-8790
    129 Site Reference ID/Investigator# 31202 Wilrijk Belgium B-2610
    130 Site Reference ID/Investigator# 31201 Woluwe St Pierre Belgium B-1150
    131 Site Reference ID/Investigator# 31216 Xhendelesse Belgium B-4652
    132 Site Reference ID/Investigator# 31221 Bascharage Luxembourg L-4918
    133 Site Reference ID/Investigator# 31172 Esch-sur-Alzette Luxembourg L-4243
    134 Site Reference ID/Investigator# 31162 Ettelbruck Luxembourg L-9002
    135 Site Reference ID/Investigator# 31231 Luxembourg Luxembourg L-2540

    Sponsors and Collaborators

    • Abbott

    Investigators

    • Study Director: Simonne Lens, Abbott

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Abbott
    ClinicalTrials.gov Identifier:
    NCT01081873
    Other Study ID Numbers:
    • PMOS-BELG-04-001
    First Posted:
    Mar 5, 2010
    Last Update Posted:
    Oct 31, 2012
    Last Verified:
    Oct 1, 2012
    Keywords provided by Abbott
    Multicenter study
    Additional relevant MeSH terms:
    Prostatic Neoplasms
    Leuprolide

    Study Results

    Participant Flow

    Recruitment Details
    Pre-assignment Detail
    Arm/Group Title Advanced Prostate Cancer Participants
    Arm/Group Description 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.
    Period Title: Overall Study
    STARTED 2714
    COMPLETED 2416
    NOT COMPLETED 298

    Baseline Characteristics

    Arm/Group Title Advanced Prostate Cancer Participants
    Arm/Group Description 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.
    Overall Participants 2714
    Age (years) [Median (Full Range) ]
    Median (Full Range) [years]
    76.18
    Age (years) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [years]
    75.39
    (7.92)
    Sex: Female, Male (Count of Participants)
    Female
    0
    0%
    Male
    2714
    100%

    Outcome Measures

    1. Primary Outcome
    Title Effectiveness Parameter for Staging of Prostate Cancer: Metastases at Each Visit
    Description 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 Frame time 0 (Baseline), month 3, and every 3 months until disease progression or up to 24 months, whichever came first

    Outcome Measure Data

    Analysis Population Description
    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.
    Arm/Group Title Advanced Prostate Cancer Participants at Baseline Advanced Prostate Cancer Participants at Month 3 Advanced Prostate Cancer Participants at Month 6 Advanced Prostate Cancer Participants at Month 9 Advanced Prostate Cancer Participants at Month 12 Advanced Prostate Cancer Participants at Month 15 Advanced Prostate Cancer Participants at Month 18 Advanced Prostate Cancer Participants at Month 21 Advanced Prostate Cancer Participants at Month 24 Advanced Prostate Cancer Participants - Last Available Record
    Arm/Group Description 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 baseline. 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 3. 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. 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. 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 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. 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. 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. 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. 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.
    Measure Participants 1262 119 73 56 109 54 64 52 310 1411
    Absent
    782
    28.8%
    59
    NaN
    45
    NaN
    28
    NaN
    74
    NaN
    33
    NaN
    44
    NaN
    29
    NaN
    188
    NaN
    870
    NaN
    Local tumor
    64
    2.4%
    10
    NaN
    3
    NaN
    3
    NaN
    2
    NaN
    1
    NaN
    0
    NaN
    3
    NaN
    10
    NaN
    64
    NaN
    Single metastases
    108
    4%
    8
    NaN
    3
    NaN
    2
    NaN
    3
    NaN
    2
    NaN
    3
    NaN
    2
    NaN
    15
    NaN
    100
    NaN
    Multiple metastases in 1 organ
    233
    8.6%
    27
    NaN
    18
    NaN
    13
    NaN
    18
    NaN
    13
    NaN
    10
    NaN
    13
    NaN
    63
    NaN
    268
    NaN
    Multiple metastases in multiple organs
    75
    2.8%
    15
    NaN
    4
    NaN
    10
    NaN
    12
    NaN
    5
    NaN
    7
    NaN
    5
    NaN
    34
    NaN
    109
    NaN
    2. Primary Outcome
    Title Effectiveness Parameter for Screening or Recurrence of Prostate Cancer: Mean Prostate-specific Antigen (PSA) at Each Visit
    Description The mean PSA in ng/mL to screen and assess for the recurrence of prostate cancer at each visit is presented.
    Time Frame time 0 (Baseline), month 3, and every 3 months until disease progression or up to 24 months, whichever came first

    Outcome Measure Data

    Analysis Population Description
    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.
    Arm/Group Title Advanced Prostate Cancer Participants at Baseline Advanced Prostate Cancer Participants at Month 3 Advanced Prostate Cancer Participants at Month 6 Advanced Prostate Cancer Participants at Month 9 Advanced Prostate Cancer Participants at Month 12 Advanced Prostate Cancer Participants at Month 15 Advanced Prostate Cancer Participants at Month 18 Advanced Prostate Cancer Participants at Month 21 Advanced Prostate Cancer Participants at Month 24 Advanced Prostate Cancer Participants - Last Available Record
    Arm/Group Description 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 baseline. 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 3. 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. 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. 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 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. 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. 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. 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. 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.
    Measure Participants 2532 944 787 595 978 493 612 401 1661 2595
    Mean (Standard Deviation) [ng/mL]
    62.16
    (282.64)
    12.95
    (88.03)
    6.23
    (34.27)
    8.01
    (43.28)
    8.41
    (52.84)
    8.88
    (44.66)
    9.57
    (57.42)
    23.02
    (141.92)
    15.29
    (129.06)
    30.32
    (183.21)
    3. Primary Outcome
    Title Effectiveness Parameter: the Number of Participants With a Complete or Partial Response, Stable Disease, or Progressive Disease Following Treatment at Each Visit
    Description 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.
    Time Frame month 3, and every 3 months until disease progression or up to 24 months, whichever came first

    Outcome Measure Data

    Analysis Population Description
    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.
    Arm/Group Title Advanced Prostate Cancer Participants at Month 3 Advanced Prostate Cancer Participants at Month 6 Advanced Prostate Cancer Participants at Month 9 Advanced Prostate Cancer Participants at Month 12 Advanced Prostate Cancer Participants at Month 15 Advanced Prostate Cancer Participants at Month 18 Advanced Prostate Cancer Participants at Month 21 Advanced Prostate Cancer Participants at Month 24 Advanced Prostate Cancer Participants - Last Available Record
    Arm/Group Description 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 3. 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. 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. 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 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. 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. 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. 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. 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.
    Measure Participants 1038 853 670 1031 565 679 475 1764 2210
    Complete response
    525
    19.3%
    496
    NaN
    402
    NaN
    668
    NaN
    347
    NaN
    401
    NaN
    276
    NaN
    1181
    NaN
    1420
    NaN
    Partial response
    379
    14%
    231
    NaN
    139
    NaN
    181
    NaN
    97
    NaN
    98
    NaN
    59
    NaN
    199
    NaN
    284
    NaN
    Stable disease
    97
    3.6%
    89
    NaN
    83
    NaN
    97
    NaN
    69
    NaN
    102
    NaN
    73
    NaN
    200
    NaN
    224
    NaN
    Progressive disease
    37
    1.4%
    37
    NaN
    46
    NaN
    85
    NaN
    52
    NaN
    78
    NaN
    67
    NaN
    184
    NaN
    282
    NaN
    4. Primary Outcome
    Title 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
    Description 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 Frame time 0 (Baseline), month 3, and every 3 months thereafter until disease progression or up to 24 months, whichever came first

    Outcome Measure Data

    Analysis Population Description
    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.
    Arm/Group Title Advanced Prostate Cancer Participants at Baseline Advanced Prostate Cancer Participants at Month 3 Advanced Prostate Cancer Participants at Month 6 Advanced Prostate Cancer Participants at Month 9 Advanced Prostate Cancer Participants at Month 12 Advanced Prostate Cancer Participants at Month 15 Advanced Prostate Cancer Participants at Month 18 Advanced Prostate Cancer Participants at Month 21 Advanced Prostate Cancer Participants at Month 24 Advanced Prostate Cancer Participants - Last Available Record
    Arm/Group Description 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 baseline. 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 3. 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. 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. 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 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. 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. 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. 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. 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.
    Measure Participants 2128 941 752 604 881 509 593 426 1495 2365
    > 10 years
    395
    14.6%
    132
    NaN
    100
    NaN
    91
    NaN
    113
    NaN
    75
    NaN
    82
    NaN
    66
    NaN
    206
    NaN
    331
    NaN
    5 - 10 years
    1041
    38.4%
    476
    NaN
    402
    NaN
    320
    NaN
    479
    NaN
    276
    NaN
    309
    NaN
    225
    NaN
    805
    NaN
    1173
    NaN
    1 - 5 years
    663
    24.4%
    312
    NaN
    237
    NaN
    180
    NaN
    268
    NaN
    140
    NaN
    182
    NaN
    117
    NaN
    420
    NaN
    735
    NaN
    6 - 12 months
    26
    1%
    15
    NaN
    10
    NaN
    11
    NaN
    18
    NaN
    15
    NaN
    13
    NaN
    12
    NaN
    48
    NaN
    93
    NaN
    < 6 months
    3
    0.1%
    6
    NaN
    3
    NaN
    2
    NaN
    3
    NaN
    3
    NaN
    7
    NaN
    6
    NaN
    16
    NaN
    33
    NaN
    5. Primary Outcome
    Title 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.
    Description 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 Frame time 0 (Baseline), month 3, and every 3 months until disease progression or up to 24 months, whichever came first

    Outcome Measure Data

    Analysis Population Description
    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.
    Arm/Group Title Advanced Prostate Cancer Participants at Baseline Advanced Prostate Cancer Participants at Month 3 Advanced Prostate Cancer Participants at Month 6 Advanced Prostate Cancer Participants at Month 9 Advanced Prostate Cancer Participants at Month 12 Advanced Prostate Cancer Participants at Month 15 Advanced Prostate Cancer Participants at Month 18 Advanced Prostate Cancer Participants at Month 21 Advanced Prostate Cancer Participants at Month 24 Advanced Prostate Cancer Participants - Use at Any Visit
    Arm/Group Description 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 baseline. 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 3. 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. 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. 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 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. 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. 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. 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. 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.
    Measure Participants 2714 1134 907 715 1082 611 717 513 1954 2714
    Any Lucrin or Lucrin Tridepot used at each visit
    2028
    74.7%
    1011
    NaN
    817
    NaN
    640
    NaN
    969
    NaN
    540
    NaN
    629
    NaN
    450
    NaN
    1628
    NaN
    2384
    NaN
    Any LHRH agonist treatments used at each visit
    2034
    74.9%
    1015
    NaN
    821
    NaN
    643
    NaN
    973
    NaN
    545
    NaN
    636
    NaN
    452
    NaN
    1635
    NaN
    2392
    NaN
    Any anti-androgen treatments used at each visit
    841
    31%
    388
    NaN
    303
    NaN
    243
    NaN
    397
    NaN
    223
    NaN
    261
    NaN
    182
    NaN
    603
    NaN
    1021
    NaN
    Other drug treatments used at each visit
    31
    1.1%
    22
    NaN
    21
    NaN
    24
    NaN
    31
    NaN
    27
    NaN
    24
    NaN
    23
    NaN
    57
    NaN
    86
    NaN
    Any surgery performed any time up to the visit
    244
    9%
    145
    NaN
    103
    NaN
    97
    NaN
    127
    NaN
    92
    NaN
    94
    NaN
    80
    NaN
    192
    NaN
    281
    NaN
    External radiation performed any time up to visit
    129
    4.8%
    84
    NaN
    76
    NaN
    73
    NaN
    79
    NaN
    43
    NaN
    56
    NaN
    33
    NaN
    133
    NaN
    228
    NaN
    Brachytherapy performed any time up to the visit
    13
    0.5%
    10
    NaN
    10
    NaN
    11
    NaN
    10
    NaN
    9
    NaN
    9
    NaN
    8
    NaN
    21
    NaN
    26
    NaN
    6. Secondary Outcome
    Title Safety Parameter: Number of Participants Reporting Serious Adverse Events (SAEs)
    Description 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.
    Time Frame Baseline to disease progression or 24 months, whichever came first

    Outcome Measure Data

    Analysis Population Description
    Analysis was performed on the full analysis set consisting of all patients for whom at least baseline data were recorded.
    Arm/Group Title Advanced Prostate Cancer Participants
    Arm/Group Description 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.
    Measure Participants 2714
    Number [participants]
    121
    4.5%
    7. Secondary Outcome
    Title Epidemiological Data: Mean Weight
    Description The mean weight of all participants at baseline is provided.
    Time Frame at time 0 (Baseline)

    Outcome Measure Data

    Analysis Population Description
    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.
    Arm/Group Title Advanced Prostate Cancer Participants
    Arm/Group Description 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.
    Measure Participants 2714
    Mean (Standard Deviation) [kg]
    77.36
    (10.48)
    8. Secondary Outcome
    Title Epidemiological Data: Mean Age
    Description The mean age of all participants at baseline is provided.
    Time Frame at time 0 (Baseline)

    Outcome Measure Data

    Analysis Population Description
    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.
    Arm/Group Title Advanced Prostate Cancer Participants
    Arm/Group Description 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.
    Measure Participants 2714
    Mean (Standard Deviation) [years]
    75.39
    (7.92)
    9. Secondary Outcome
    Title Epidemiological Data: Race
    Description The number of participants by race at baseline is presented.
    Time Frame at time 0 (Baseline)

    Outcome Measure Data

    Analysis Population Description
    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.
    Arm/Group Title Advanced Prostate Cancer Participants
    Arm/Group Description 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.
    Measure Participants 2217
    Black
    59
    2.2%
    Caucasian
    2154
    79.4%
    Other
    4
    0.1%
    10. Secondary Outcome
    Title 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.
    Description Among those participants with a positive biopsy at baseline, the number of participants with adenocarcinoma tissue or other tissue type is summarized.
    Time Frame at time 0 (Baseline)

    Outcome Measure Data

    Analysis Population Description
    Analysis was performed on the full analysis set (all patients for whom at least baseline data were recorded) and all available data.
    Arm/Group Title Advanced Prostate Cancer Participants at Baseline
    Arm/Group Description Participants with advanced prostate cancer treated with Lucrin /Lucrin- Tri-depot (leuprolide) or any other treatment with local reimbursement guidelines that had a tissue type recorded at Baseline.
    Measure Participants 2279
    Adenocarcinoma
    2269
    83.6%
    Other
    9
    0.3%
    Not done
    1
    0%
    11. Secondary Outcome
    Title Epidemiological Data: PSA at Baseline
    Description 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.
    Time Frame at time 0 (Baseline)

    Outcome Measure Data

    Analysis Population Description
    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.
    Arm/Group Title Advanced Prostate Cancer Participants
    Arm/Group Description 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.
    Measure Participants 2532
    Median (Full Range) [ng/mL]
    13.66
    12. Secondary Outcome
    Title Epidemiological Data: Tumor Staging (Positive or Negative) Via a Rectal Examination, Prostate Biopsy, Echograph, or Magnetic Resonance Imaging (MRI) Test.
    Description 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.
    Time Frame at time 0 (Baseline)

    Outcome Measure Data

    Analysis Population Description
    Analysis was performed on the full analysis set (all patients for whom at least baseline data were recorded) and all available data.
    Arm/Group Title Advanced Prostate Cancer Participants - Rectal Examination Advanced Prostate Cancer Participants - Prostate Biopsy Advanced Prostate Cancer Participants - Echograph Advanced Prostate Cancer Participants - MRI
    Arm/Group Description 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 rectal examination. 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 a prostate biopsy. 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 an echograph (hyperechogenic zones). 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.
    Measure Participants 2484 2364 2252 187
    Positive at baseline
    2045
    75.4%
    2355
    NaN
    1806
    NaN
    102
    NaN
    Negative at baseline
    439
    16.2%
    9
    NaN
    446
    NaN
    85
    NaN
    13. Secondary Outcome
    Title Epidemiological Data: the Number of Participants With Tumor Stages T0, T1, T2, T3, and T4.
    Description 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.
    Time Frame at time 0 (Baseline)

    Outcome Measure Data

    Analysis Population Description
    Analysis was performed on the full analysis set (all patients for whom at least baseline data were recorded) and all available data.
    Arm/Group Title Advanced Prostate Cancer Participants
    Arm/Group Description 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.
    Measure Participants 2302
    T0 stage
    30
    1.1%
    T1 stage
    223
    8.2%
    T2 stage
    614
    22.6%
    T3 stage
    1215
    44.8%
    T4 stage
    220
    8.1%
    14. Secondary Outcome
    Title Epidemiological Data: Node Staging - the Number of Participants With a Positive or Negative Computerized Tomography (CT) Scan or Magnetic Resonance Imaging (MRI) Test
    Description 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.
    Time Frame at time 0 (Baseline)

    Outcome Measure Data

    Analysis Population Description
    Analysis was performed on the full analysis set (all patients for whom at least baseline data were recorded) and all available data.
    Arm/Group Title Advanced Prostate Cancer Participants
    Arm/Group Description 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.
    Measure Participants 1586
    Positive at baseline
    374
    13.8%
    Negative at baseline
    1212
    44.7%
    15. Secondary Outcome
    Title Epidemiological Data: Node Staging - the Number of Participants With a N0 or N1 Stage at Baseline.
    Description N0: tumor cells absent from regional lymph nodes. N1: regional lymph node metastasis present.
    Time Frame at time 0 (Baseline)

    Outcome Measure Data

    Analysis Population Description
    Analysis was performed on the full analysis set (all patients for whom at least baseline data were recorded) and all available data.
    Arm/Group Title Advanced Prostate Cancer Participants
    Arm/Group Description 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.
    Measure Participants 1656
    N0 stage
    1296
    47.8%
    N1 stage
    360
    13.3%
    16. Secondary Outcome
    Title Epidemiological Data: Bone Scan at Baseline
    Description 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.
    Time Frame at time 0 (Baseline)

    Outcome Measure Data

    Analysis Population Description
    Analysis was performed on the full analysis set (all patients for whom at least baseline data were recorded) and all available data.
    Arm/Group Title Advanced Prostate Cancer Participants
    Arm/Group Description 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.
    Measure Participants 1850
    Positive at baseline
    497
    18.3%
    Negative at baseline
    1353
    49.9%
    17. Secondary Outcome
    Title Epidemiological Data: Metastasis Staging (M0 or M1) at Baseline
    Description 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.
    Time Frame at time 0 (Baseline)

    Outcome Measure Data

    Analysis Population Description
    Analysis was performed on the full analysis set (all patients for whom at least baseline data were recorded) and all available data.
    Arm/Group Title Advanced Prostate Cancer Participants
    Arm/Group Description 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.
    Measure Participants 1874
    M0 stage
    1373
    50.6%
    M1 stage
    501
    18.5%

    Adverse Events

    Time Frame All adverse events that occurred during the course of the study were reported and followed to a satisfactory conclusion.
    Adverse Event Reporting Description
    Arm/Group Title Advanced Prostate Cancer Participants
    Arm/Group Description 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.
    All Cause Mortality
    Advanced Prostate Cancer Participants
    Affected / at Risk (%) # Events
    Total / (NaN)
    Serious Adverse Events
    Advanced Prostate Cancer Participants
    Affected / at Risk (%) # Events
    Total 121/2714 (4.5%)
    Blood and lymphatic system disorders
    Anaemia 1/2714 (0%)
    Neutropenia 1/2714 (0%)
    Cardiac disorders
    Acute myocardial infarction 1/2714 (0%)
    Aortic valve stenosis 1/2714 (0%)
    Atrial fibrillation 1/2714 (0%)
    Cardiac arrest 4/2714 (0.1%)
    Cardiac disorder 1/2714 (0%)
    Cardiac failure 10/2714 (0.4%)
    Cardiac failure chronic 1/2714 (0%)
    Cardio-respiratory arrest 1/2714 (0%)
    Cardiogenic shock 1/2714 (0%)
    Cardiomyopathy 1/2714 (0%)
    Cardiopulmonary failure 2/2714 (0.1%)
    Cardiovascular disorder 2/2714 (0.1%)
    Myocardial infarction 7/2714 (0.3%)
    Ventricular tachycardia 1/2714 (0%)
    Gastrointestinal disorders
    Abdominal discomfort 1/2714 (0%)
    Dysphagia 1/2714 (0%)
    Enterovesical fistula 1/2714 (0%)
    Large intestine perforation 1/2714 (0%)
    Peritonitis 1/2714 (0%)
    General disorders
    Death 8/2714 (0.3%)
    Disease progression 7/2714 (0.3%)
    Fatigue 1/2714 (0%)
    General physical health deterioration 4/2714 (0.1%)
    Multi-organ failure 2/2714 (0.1%)
    Terminal state 2/2714 (0.1%)
    Therapeutic response decreased 1/2714 (0%)
    Hepatobiliary disorders
    Cholecystitis acute 1/2714 (0%)
    Hepatic failure 1/2714 (0%)
    Infections and infestations
    Bronchitis 2/2714 (0.1%)
    Bronchopneumonia 1/2714 (0%)
    Lung infection 2/2714 (0.1%)
    Pneumonia 5/2714 (0.2%)
    Pulmonary sepsis 1/2714 (0%)
    Sepsis 4/2714 (0.1%)
    Superinfection 1/2714 (0%)
    Injury, poisoning and procedural complications
    Accident 1/2714 (0%)
    Subdural haematoma 1/2714 (0%)
    Investigations
    Cardiac enzymes increased 1/2714 (0%)
    Prostatic specific antigen abnormal 1/2714 (0%)
    Metabolism and nutrition disorders
    Cachexia 2/2714 (0.1%)
    Decreased appetite 2/2714 (0.1%)
    Dehydration 1/2714 (0%)
    Diabetes mellitus 1/2714 (0%)
    Diet refusal 1/2714 (0%)
    Hypoglycaemia 1/2714 (0%)
    Lactic acidosis 1/2714 (0%)
    Musculoskeletal and connective tissue disorders
    Bone disorder 1/2714 (0%)
    Muscular weakness 1/2714 (0%)
    Pathological fracture 1/2714 (0%)
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Bladder cancer 1/2714 (0%)
    Breast cancer male 2/2714 (0.1%)
    Colon cancer 1/2714 (0%)
    Lung neoplasm 2/2714 (0.1%)
    Lung neoplasm malignant 3/2714 (0.1%)
    Metastases to bladder 1/2714 (0%)
    Metastases to bone 11/2714 (0.4%)
    Metastases to central nervous system 1/2714 (0%)
    Metastases to liver 5/2714 (0.2%)
    Metastases to lung 3/2714 (0.1%)
    Metastases to lymph nodes 3/2714 (0.1%)
    Metastasis 5/2714 (0.2%)
    Metastatic neoplasm 1/2714 (0%)
    Neoplasm malignant 2/2714 (0.1%)
    Pancreatic carcinoma 2/2714 (0.1%)
    Prostate cancer 24/2714 (0.9%)
    Prostate cancer metastatic 5/2714 (0.2%)
    Rectal cancer 1/2714 (0%)
    Small cell carcinoma 1/2714 (0%)
    Ureteral neoplasm 1/2714 (0%)
    Nervous system disorders
    Cerebral haemorrhage 1/2714 (0%)
    Cerebrovascular accident 1/2714 (0%)
    Coma 2/2714 (0.1%)
    Dementia 1/2714 (0%)
    Dementia Alzheimer's type 1/2714 (0%)
    Depressed level of consciousness 1/2714 (0%)
    Haemorrhagic stroke 1/2714 (0%)
    Headache 1/2714 (0%)
    Parkinson's disease 1/2714 (0%)
    Thrombotic stroke 1/2714 (0%)
    Transient ischaemic attack 1/2714 (0%)
    Psychiatric disorders
    Depression 1/2714 (0%)
    Renal and urinary disorders
    Anuria 1/2714 (0%)
    Azotaemia 1/2714 (0%)
    Dysuria 1/2714 (0%)
    Hydronephrosis 1/2714 (0%)
    Renal failure 2/2714 (0.1%)
    Renal failure acute 1/2714 (0%)
    Respiratory, thoracic and mediastinal disorders
    Acute respiratory failure 1/2714 (0%)
    Chronic obstructive pulmonary disease 2/2714 (0.1%)
    Emphysema 2/2714 (0.1%)
    Hypercapnia 1/2714 (0%)
    Hyperventilation 1/2714 (0%)
    Hypoxia 1/2714 (0%)
    Pulmonary embolism 2/2714 (0.1%)
    Pulmonary oedema 1/2714 (0%)
    Respiratory acidosis 1/2714 (0%)
    Respiratory arrest 1/2714 (0%)
    Respiratory failure 4/2714 (0.1%)
    Surgical and medical procedures
    Bladder catheterisation 1/2714 (0%)
    Cardiac operation 1/2714 (0%)
    Vascular disorders
    Angiopathy 1/2714 (0%)
    Embolism 1/2714 (0%)
    Infarction 1/2714 (0%)
    Thrombophlebitis 1/2714 (0%)
    Other (Not Including Serious) Adverse Events
    Advanced Prostate Cancer Participants
    Affected / at Risk (%) # Events
    Total 8/2714 (0.3%)
    Congenital, familial and genetic disorders
    Porphyria non-acute 1/2714 (0%) 1
    General disorders
    Fatigue 1/2714 (0%) 1
    Musculoskeletal and connective tissue disorders
    Osteopenia 1/2714 (0%) 1
    Nervous system disorders
    Syncope 1/2714 (0%) 1
    Renal and urinary disorders
    Urinary retention 1/2714 (0%) 1
    Reproductive system and breast disorders
    Gynaecomastia 1/2714 (0%) 1
    Vascular disorders
    Hot flush 2/2714 (0.1%) 2

    Limitations/Caveats

    [Not Specified]

    More Information

    Certain Agreements

    Principal Investigators are NOT employed by the organization sponsoring the study.

    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.

    Results Point of Contact

    Name/Title Global Medical Services
    Organization Abbott
    Phone 800-633-9110
    Email
    Responsible Party:
    Abbott
    ClinicalTrials.gov Identifier:
    NCT01081873
    Other Study ID Numbers:
    • PMOS-BELG-04-001
    First Posted:
    Mar 5, 2010
    Last Update Posted:
    Oct 31, 2012
    Last Verified:
    Oct 1, 2012