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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Abbott
ClinicalTrials.gov Identifier:
NCT01081873
First received: February 27, 2010
Last updated: October 26, 2012
Last verified: October 2012
  Purpose

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 Intervention
Prostatic Neoplasm
Drug: leuprolide (Lucrin/Lucrin-Tri-depot)

Study Type: Observational
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Abbott:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    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.

  • 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 ] [ Designated as safety issue: No ]
    The mean PSA in ng/mL to screen and assess for the recurrence of prostate cancer at each visit is presented.

  • 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 ] [ Designated as safety issue: No ]
    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.

  • 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 ] [ Designated as safety issue: No ]
    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.

  • 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 ] [ Designated as safety issue: No ]
    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:
  • Safety Parameter: Number of Participants Reporting Serious Adverse Events (SAEs) [ Time Frame: Baseline to disease progression or 24 months, whichever came first ] [ Designated as safety issue: Yes ]
    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.

  • Epidemiological Data: Mean Weight [ Time Frame: at time 0 (Baseline) ] [ Designated as safety issue: No ]
    The mean weight of all participants at baseline is provided.

  • Epidemiological Data: Mean Age [ Time Frame: at time 0 (Baseline) ] [ Designated as safety issue: No ]
    The mean age of all participants at baseline is provided.

  • Epidemiological Data: Race [ Time Frame: at time 0 (Baseline) ] [ Designated as safety issue: No ]
    The number of participants by race at baseline is presented.

  • 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) ] [ Designated as safety issue: No ]
    Among those participants with a positive biopsy at baseline, the number of participants with adenocarcinoma tissue or other tissue type is summarized.

  • Epidemiological Data: PSA at Baseline [ Time Frame: at time 0 (Baseline) ] [ Designated as safety issue: No ]
    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.

  • 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) ] [ Designated as safety issue: No ]
    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.

  • Epidemiological Data: the Number of Participants With Tumor Stages T0, T1, T2, T3, and T4. [ Time Frame: at time 0 (Baseline) ] [ Designated as safety issue: No ]
    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.

  • 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) ] [ Designated as safety issue: No ]
    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.

  • Epidemiological Data: Node Staging - the Number of Participants With a N0 or N1 Stage at Baseline. [ Time Frame: at time 0 (Baseline) ] [ Designated as safety issue: No ]
    N0: tumor cells absent from regional lymph nodes. N1: regional lymph node metastasis present.

  • Epidemiological Data: Bone Scan at Baseline [ Time Frame: at time 0 (Baseline) ] [ Designated as safety issue: No ]
    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.

  • Epidemiological Data: Metastasis Staging (M0 or M1) at Baseline [ Time Frame: at time 0 (Baseline) ] [ Designated as safety issue: No ]
    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.


Enrollment: 2717
Study Start Date: June 2004
Study Completion Date: December 2010
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Urologists

Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01081873

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

No publications provided

Responsible Party: Abbott
ClinicalTrials.gov Identifier: NCT01081873     History of Changes
Other Study ID Numbers: PMOS-BELG-04-001
Study First Received: February 27, 2010
Results First Received: December 22, 2011
Last Updated: October 26, 2012
Health Authority: Belgium: Institutional Review Board

Keywords provided by Abbott:
Multicenter study

Additional relevant MeSH terms:
Neoplasms
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Genital Diseases, Male
Prostatic Diseases
Leuprolide
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Fertility Agents, Female
Fertility Agents
Reproductive Control Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on July 20, 2014