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

October 26, 2012 updated by: Abbott

A Post-Marketing Observational Study to Document Treatment Patterns and to Evaluate Leuprolide and Alternative Therapeutic Approaches to the Treatment of Advanced Prostate Cancer

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

2717

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Aartselaar, Belgium, B-2630
        • Site Reference ID/Investigator# 31196
      • Afsnee, Belgium, B-9051
        • Site Reference ID/Investigator# 31237
      • Alken, Belgium, B-3570
        • Site Reference ID/Investigator# 31121
      • Antwerp, Belgium, B-2020
        • Site Reference ID/Investigator# 4872
      • Antwerp, Belgium, B-2050
        • Site Reference ID/Investigator# 31186
      • Antwerpen, Belgium, B-2018
        • Site Reference ID/Investigator# 31170
      • Antwerpen, Belgium, B-2018
        • Site Reference ID/Investigator# 31194
      • Arlon, Belgium, B-6700
        • Site Reference ID/Investigator# 31141
      • Arlon, Belgium, B-6700
        • Site Reference ID/Investigator# 31199
      • Ath, Belgium, B-7804
        • Site Reference ID/Investigator# 31247
      • Baulers, Belgium, B-1401
        • Site Reference ID/Investigator# 31190
      • Beerse, Belgium, B-2340
        • Site Reference ID/Investigator# 31210
      • Berchem, Belgium, B-2600
        • Site Reference ID/Investigator# 31171
      • Berlaar, Belgium, B-2590
        • Site Reference ID/Investigator# 31137
      • Beveren, Belgium, B-8800
        • Site Reference ID/Investigator# 31204
      • Boutersem, Belgium, B-3370
        • Site Reference ID/Investigator# 31184
      • Braine-Le-Chateau, Belgium, B-1440
        • Site Reference ID/Investigator# 31205
      • Brasschaat, Belgium, B-2930
        • Site Reference ID/Investigator# 31217
      • Bruges, Belgium, B-8310
        • Site Reference ID/Investigator# 31133
      • Bruges, Belgium, B-8310
        • Site Reference ID/Investigator# 31135
      • Brugge, Belgium, B-8310
        • Site Reference ID/Investigator# 31134
      • Brussels, Belgium, B-1000
        • Site Reference ID/Investigator# 31233
      • Brussels, Belgium, B-1160
        • Site Reference ID/Investigator# 31252
      • Brussels, Belgium, B-1200
        • Site Reference ID/Investigator# 31232
      • Bruxelles, Belgium, B-1020
        • Site Reference ID/Investigator# 31161
      • Bruxelles, Belgium, B-1030
        • Site Reference ID/Investigator# 31223
      • Bruxelles, Belgium, B-1050
        • Site Reference ID/Investigator# 31152
      • Bruxelles, Belgium, B-1081
        • Site Reference ID/Investigator# 31251
      • Bruxelles, Belgium, B-1083
        • Site Reference ID/Investigator# 31178
      • Bruxelles, Belgium, B-1090
        • Site Reference ID/Investigator# 31236
      • Bruxelles, Belgium, B-1180
        • Site Reference ID/Investigator# 31117
      • Bruxelles, Belgium, B-1180
        • Site Reference ID/Investigator# 31203
      • Bruxelles, Belgium, B-1853
        • Site Reference ID/Investigator# 31200
      • Court St. Etienne, Belgium, B-1490
        • Site Reference ID/Investigator# 31129
      • Cuesmes, Belgium, B-7033
        • Site Reference ID/Investigator# 31244
      • Damme, Belgium, B-8340
        • Site Reference ID/Investigator# 31208
      • Dendermonde, Belgium, B-9200
        • Site Reference ID/Investigator# 31155
      • Dendermonde, Belgium, B-9200
        • Site Reference ID/Investigator# 31197
      • Diest, Belgium, B-3290
        • Site Reference ID/Investigator# 31189
      • Dilbeek, Belgium, B-1700
        • Site Reference ID/Investigator# 31126
      • Dworp, Belgium, B-1653
        • Site Reference ID/Investigator# 31116
      • Dworp, Belgium, B-1653
        • Site Reference ID/Investigator# 31160
      • Elingen, Belgium, B-1671
        • Site Reference ID/Investigator# 31179
      • Embourg, Belgium, B-4053
        • Site Reference ID/Investigator# 31249
      • Erpent, Belgium, B-5101
        • Site Reference ID/Investigator# 31166
      • Esneux, Belgium, B-4130
        • Site Reference ID/Investigator# 31192
      • Falmagne, Belgium, B-5500
        • Site Reference ID/Investigator# 31188
      • Feluy, Belgium, B-7181
        • Site Reference ID/Investigator# 31195
      • Floreffe, Belgium, B-5150
        • Site Reference ID/Investigator# 31250
      • Genk, Belgium, B-3600
        • Site Reference ID/Investigator# 31183
      • Genk-Waterschei, Belgium, B-3600
        • Site Reference ID/Investigator# 31173
      • Gent, Belgium, B-9000
        • Site Reference ID/Investigator# 31228
      • Gent, Belgium, B-9000
        • Site Reference ID/Investigator# 46502
      • Gouy-Les-Pietons, Belgium, B-6181
        • Site Reference ID/Investigator# 31132
      • Halle, Belgium, B-1500
        • Site Reference ID/Investigator# 31124
      • Hamme, Belgium, B-9220
        • Site Reference ID/Investigator# 31191
      • Hasselt, Belgium, B-3510
        • Site Reference ID/Investigator# 31234
      • Heusy, Belgium, B-4802
        • Site Reference ID/Investigator# 31227
      • Hofstade, Belgium, B-1981
        • Site Reference ID/Investigator# 31212
      • Hove, Belgium, B-2540
        • Site Reference ID/Investigator# 31143
      • Huy, Belgium, B-4500
        • Site Reference ID/Investigator# 31226
      • Izegem, Belgium, B-8870
        • Site Reference ID/Investigator# 31119
      • Izegem, Belgium, B-8870
        • Site Reference ID/Investigator# 31181
      • Knokke, Belgium, B-8300
        • Site Reference ID/Investigator# 31149
      • Koksijde, Belgium, B-8670
        • Site Reference ID/Investigator# 31177
      • Kortrijk, Belgium, B-8500
        • Site Reference ID/Investigator# 31253
      • Lasne, Belgium, B-1380
        • Site Reference ID/Investigator# 31130
      • Lennik, Belgium, B-1750
        • Site Reference ID/Investigator# 31159
      • Leper, Belgium, B-8900
        • Site Reference ID/Investigator# 31123
      • Leper, Belgium, B-8900
        • Site Reference ID/Investigator# 31241
      • Lesves, Belgium, B-1380
        • Site Reference ID/Investigator# 31255
      • Leuven, Belgium, 3000
        • Site Reference ID/Investigator# 31259
      • Libramont, Belgium, B-6800
        • Site Reference ID/Investigator# 31219
      • Liege, Belgium, B-4000
        • Site Reference ID/Investigator# 31128
      • Liege, Belgium, B-4000
        • Site Reference ID/Investigator# 31144
      • Liege, Belgium, B-4000
        • Site Reference ID/Investigator# 31185
      • Liege, Belgium, B-4000
        • Site Reference ID/Investigator# 31207
      • Liege, Belgium, B-4000
        • Site Reference ID/Investigator# 31245
      • Lier, Belgium, B2400
        • Site Reference ID/Investigator# 31224
      • Lommel, Belgium, B-3920
        • Site Reference ID/Investigator# 31243
      • Marcinelle, Belgium, B-6001
        • Site Reference ID/Investigator# 31225
      • Marcq, Belgium, B-7850
        • Site Reference ID/Investigator# 31139
      • Mol, Belgium, B-2400
        • Site Reference ID/Investigator# 31206
      • Mons, Belgium, B-7000
        • Site Reference ID/Investigator# 31153
      • Mons, Belgium, B-7000
        • Site Reference ID/Investigator# 31257
      • Mont-sur-Marchienne, Belgium, B-6032
        • Site Reference ID/Investigator# 31140
      • Mortsel, Belgium, B2640
        • Site Reference ID/Investigator# 31222
      • Namur, Belgium, B-5000
        • Site Reference ID/Investigator# 31164
      • Nivelles, Belgium, B-1400
        • Site Reference ID/Investigator# 31258
      • Oordegem, Belgium, B-9340
        • Site Reference ID/Investigator# 31218
      • Oostende, Belgium, B-8400
        • Site Reference ID/Investigator# 31214
      • Oostende, Belgium, B-8400
        • Site Reference ID/Investigator# 31242
      • Oosterzele, Belgium, B-9860
        • Site Reference ID/Investigator# 31156
      • Ottignies, Belgium, B-1340
        • Site Reference ID/Investigator# 31131
      • Oudenaarde, Belgium, B-9700
        • Site Reference ID/Investigator# 31163
      • Overijse, Belgium, B-3090
        • Site Reference ID/Investigator# 31125
      • Pollinkhove, Belgium, B-8647
        • Site Reference ID/Investigator# 31198
      • Ragnies, Belgium, B-6532
        • Site Reference ID/Investigator# 31229
      • Rijmenam, Belgium, B-2820
        • Site Reference ID/Investigator# 31138
      • Roeselare, Belgium, B-8800
        • Site Reference ID/Investigator# 31122
      • Roeslare, Belgium, B-8800
        • Site Reference ID/Investigator# 31174
      • Rotselaar, Belgium, B-3110
        • Site Reference ID/Investigator# 31136
      • Rumbeke, Belgium, B-8800
        • Site Reference ID/Investigator# 31180
      • S. Gravenwezel, Belgium, B-2970
        • Site Reference ID/Investigator# 31147
      • Saint Ghislain, Belgium, B-7330
        • Site Reference ID/Investigator# 31215
      • Saintes, Belgium, B-1480
        • Site Reference ID/Investigator# 31176
      • Schilde, Belgium, B-2970
        • Site Reference ID/Investigator# 31168
      • Schoten, Belgium, B-2900
        • Site Reference ID/Investigator# 31220
      • Schoten, Belgium, B-2900
        • Site Reference ID/Investigator# 31238
      • Seneffe, Belgium, B-7180
        • Site Reference ID/Investigator# 31142
      • Seraing, Belgium, B-4100
        • Site Reference ID/Investigator# 31158
      • Silly, Belgium, B-7830
        • Site Reference ID/Investigator# 31246
      • Sint Niklaas, Belgium, B-9100
        • Site Reference ID/Investigator# 31240
      • Sint Truiden, Belgium, B-3800
        • Site Reference ID/Investigator# 31120
      • Sint-Genesius-Rode, Belgium, B-1640
        • Site Reference ID/Investigator# 31230
      • Sirault, Belgium, B-7332
        • Site Reference ID/Investigator# 31213
      • St Denis, Belgium, B-7034
        • Site Reference ID/Investigator# 31150
      • St. Truiden, Belgium, B-3800
        • Site Reference ID/Investigator# 31157
      • Tielt, Belgium, B-8700
        • Site Reference ID/Investigator# 31182
      • Tilff, Belgium, B-4130
        • Site Reference ID/Investigator# 31248
      • Tournai, Belgium, B-7500
        • Site Reference ID/Investigator# 31151
      • Tremelo, Belgium, B-3120
        • Site Reference ID/Investigator# 31146
      • Uccle, Belgium, B-1180
        • Site Reference ID/Investigator# 31254
      • Uccle, Belgium, B-1180
        • Site Reference ID/Investigator# 31256
      • Veerle, Belgium, B-2431
        • Site Reference ID/Investigator# 31165
      • Villers-Saint-Simeon, Belgium, B-4453
        • Site Reference ID/Investigator# 31193
      • Wanze, Belgium, B-4520
        • Site Reference ID/Investigator# 31175
      • Waregem, Belgium, B-8790
        • Site Reference ID/Investigator# 31145
      • Wilrijk, Belgium, B-2610
        • Site Reference ID/Investigator# 31202
      • Woluwe St Pierre, Belgium, B-1150
        • Site Reference ID/Investigator# 31201
      • Xhendelesse, Belgium, B-4652
        • Site Reference ID/Investigator# 31216
  • Luxembourg
      • Bascharage, Luxembourg, L-4918
        • Site Reference ID/Investigator# 31221
      • Esch-sur-Alzette, Luxembourg, L-4243
        • Site Reference ID/Investigator# 31172
      • Ettelbruck, Luxembourg, L-9002
        • Site Reference ID/Investigator# 31162
      • Luxembourg, Luxembourg, L-2540
        • Site Reference ID/Investigator# 31231

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Sampling Method

Non-Probability Sample

Study Population

Urologists

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Safety Parameter: Number of Participants Reporting Serious Adverse Events (SAEs)
Time Frame: 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.
Baseline to disease progression or 24 months, whichever came first
Epidemiological Data: Mean Weight
Time Frame: at time 0 (Baseline)
The mean weight of all participants at baseline is provided.
at time 0 (Baseline)
Epidemiological Data: Mean Age
Time Frame: at time 0 (Baseline)
The mean age of all participants at baseline is provided.
at time 0 (Baseline)
Epidemiological Data: Race
Time Frame: at time 0 (Baseline)
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.
Time Frame: 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.
at time 0 (Baseline)
Epidemiological Data: PSA at Baseline
Time Frame: 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.
at time 0 (Baseline)
Epidemiological Data: Tumor Staging (Positive or Negative) Via a Rectal Examination, Prostate Biopsy, Echograph, or Magnetic Resonance Imaging (MRI) Test.
Time Frame: 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.
at time 0 (Baseline)
Epidemiological Data: the Number of Participants With Tumor Stages T0, T1, T2, T3, and T4.
Time Frame: 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.
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
Time Frame: 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.
at time 0 (Baseline)
Epidemiological Data: Node Staging - the Number of Participants With a N0 or N1 Stage at Baseline.
Time Frame: at time 0 (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
Time Frame: 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.
at time 0 (Baseline)
Epidemiological Data: Metastasis Staging (M0 or M1) at Baseline
Time Frame: 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.
at time 0 (Baseline)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Abbott

Investigators

  • Study Director: Simonne Lens, Abbott

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2004

Primary Completion (ACTUAL)

December 1, 2010

Study Completion (ACTUAL)

December 1, 2010

Study Registration Dates

First Submitted

February 27, 2010

First Submitted That Met QC Criteria

March 4, 2010

First Posted (ESTIMATE)

March 5, 2010

Study Record Updates

Last Update Posted (ESTIMATE)

October 31, 2012

Last Update Submitted That Met QC Criteria

October 26, 2012

Last Verified

October 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PMOS-BELG-04-001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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