Study to Document Treatment Patterns and to Evaluate Leuprolide and Alternative Therapeutic Approaches to the Treatments of Advanced Prostate Cancer
- Registration Number
- NCT01081873
- Lead Sponsor
- Abbott
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 2717
- 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.
- Contraindications according to the Summary of Product Characteristics (SPC).
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Advanced prostate cancer participants leuprolide (Lucrin/Lucrin-Tri-depot) Participants with advanced prostate cancer treated with Lucrin /Lucrin- Tri-depot (leuprolide) or any other treatment within local reimbursement guidelines.
- Primary Outcome Measures
Name Time Method 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.
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.
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.
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.
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
Name Time Method 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.
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.
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.
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.
Epidemiological Data: Mean Weight at time 0 (Baseline) The mean weight of all participants at baseline is provided.
Epidemiological Data: Mean Age at time 0 (Baseline) The mean age of all participants at baseline is provided.
Epidemiological Data: Race at time 0 (Baseline) 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. 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.
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.
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.
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.
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.
Trial Locations
- Locations (135)
Site Reference ID/Investigator# 31203
🇧🇪Bruxelles, Belgium
Site Reference ID/Investigator# 31236
🇧🇪Bruxelles, Belgium
Site Reference ID/Investigator# 31200
🇧🇪Bruxelles, Belgium
Site Reference ID/Investigator# 31244
🇧🇪Cuesmes, Belgium
Site Reference ID/Investigator# 31197
🇧🇪Dendermonde, Belgium
Site Reference ID/Investigator# 31189
🇧🇪Diest, Belgium
Site Reference ID/Investigator# 31131
🇧🇪Ottignies, Belgium
Site Reference ID/Investigator# 31195
🇧🇪Feluy, Belgium
Site Reference ID/Investigator# 31250
🇧🇪Floreffe, Belgium
Site Reference ID/Investigator# 31198
🇧🇪Pollinkhove, Belgium
Site Reference ID/Investigator# 31257
🇧🇪Mons, Belgium
Site Reference ID/Investigator# 31174
🇧🇪Roeslare, Belgium
Site Reference ID/Investigator# 31125
🇧🇪Overijse, Belgium
Site Reference ID/Investigator# 31138
🇧🇪Rijmenam, Belgium
Site Reference ID/Investigator# 31158
🇧🇪Seraing, Belgium
Site Reference ID/Investigator# 31256
🇧🇪Uccle, Belgium
Site Reference ID/Investigator# 31202
🇧🇪Wilrijk, Belgium
Site Reference ID/Investigator# 31175
🇧🇪Wanze, Belgium
Site Reference ID/Investigator# 31201
🇧🇪Woluwe St Pierre, Belgium
Site Reference ID/Investigator# 31227
🇧🇪Heusy, Belgium
Site Reference ID/Investigator# 31119
🇧🇪Izegem, Belgium
Site Reference ID/Investigator# 31253
🇧🇪Kortrijk, Belgium
Site Reference ID/Investigator# 31255
🇧🇪Lesves, Belgium
Site Reference ID/Investigator# 31212
🇧🇪Hofstade, Belgium
Site Reference ID/Investigator# 31143
🇧🇪Hove, Belgium
Site Reference ID/Investigator# 31130
🇧🇪Lasne, Belgium
Site Reference ID/Investigator# 31159
🇧🇪Lennik, Belgium
Site Reference ID/Investigator# 31123
🇧🇪Leper, Belgium
Site Reference ID/Investigator# 31224
🇧🇪Lier, Belgium
Site Reference ID/Investigator# 31225
🇧🇪Marcinelle, Belgium
Site Reference ID/Investigator# 31241
🇧🇪Leper, Belgium
Site Reference ID/Investigator# 31219
🇧🇪Libramont, Belgium
Site Reference ID/Investigator# 31128
🇧🇪Liege, Belgium
Site Reference ID/Investigator# 31214
🇧🇪Oostende, Belgium
Site Reference ID/Investigator# 31163
🇧🇪Oudenaarde, Belgium
Site Reference ID/Investigator# 31144
🇧🇪Liege, Belgium
Site Reference ID/Investigator# 31245
🇧🇪Liege, Belgium
Site Reference ID/Investigator# 31222
🇧🇪Mortsel, Belgium
Site Reference ID/Investigator# 31164
🇧🇪Namur, Belgium
Site Reference ID/Investigator# 31242
🇧🇪Oostende, Belgium
Site Reference ID/Investigator# 31136
🇧🇪Rotselaar, Belgium
Site Reference ID/Investigator# 31196
🇧🇪Aartselaar, Belgium
Site Reference ID/Investigator# 4872
🇧🇪Antwerp, Belgium
Site Reference ID/Investigator# 31237
🇧🇪Afsnee, Belgium
Site Reference ID/Investigator# 31186
🇧🇪Antwerp, Belgium
Site Reference ID/Investigator# 31141
🇧🇪Arlon, Belgium
Site Reference ID/Investigator# 31194
🇧🇪Antwerpen, Belgium
Site Reference ID/Investigator# 31190
🇧🇪Baulers, Belgium
Site Reference ID/Investigator# 31137
🇧🇪Berlaar, Belgium
Site Reference ID/Investigator# 31184
🇧🇪Boutersem, Belgium
Site Reference ID/Investigator# 31204
🇧🇪Beveren, Belgium
Site Reference ID/Investigator# 31133
🇧🇪Bruges, Belgium
Site Reference ID/Investigator# 31135
🇧🇪Bruges, Belgium
Site Reference ID/Investigator# 31134
🇧🇪Brugge, Belgium
Site Reference ID/Investigator# 31252
🇧🇪Brussels, Belgium
Site Reference ID/Investigator# 31161
🇧🇪Bruxelles, Belgium
Site Reference ID/Investigator# 31223
🇧🇪Bruxelles, Belgium
Site Reference ID/Investigator# 31232
🇧🇪Brussels, Belgium
Site Reference ID/Investigator# 31251
🇧🇪Bruxelles, Belgium
Site Reference ID/Investigator# 31152
🇧🇪Bruxelles, Belgium
Site Reference ID/Investigator# 31178
🇧🇪Bruxelles, Belgium
Site Reference ID/Investigator# 31132
🇧🇪Gouy-Les-Pietons, Belgium
Site Reference ID/Investigator# 31179
🇧🇪Elingen, Belgium
Site Reference ID/Investigator# 31249
🇧🇪Embourg, Belgium
Site Reference ID/Investigator# 31156
🇧🇪Oosterzele, Belgium
Site Reference ID/Investigator# 31259
🇧🇪Leuven, Belgium
Site Reference ID/Investigator# 31140
🇧🇪Mont-sur-Marchienne, Belgium
Site Reference ID/Investigator# 31218
🇧🇪Oordegem, Belgium
Site Reference ID/Investigator# 31246
🇧🇪Silly, Belgium
Site Reference ID/Investigator# 31176
🇧🇪Saintes, Belgium
Site Reference ID/Investigator# 31168
🇧🇪Schilde, Belgium
Site Reference ID/Investigator# 31146
🇧🇪Tremelo, Belgium
Site Reference ID/Investigator# 31216
🇧🇪Xhendelesse, Belgium
Site Reference ID/Investigator# 31170
🇧🇪Antwerpen, Belgium
Site Reference ID/Investigator# 31199
🇧🇪Arlon, Belgium
Site Reference ID/Investigator# 31247
🇧🇪Ath, Belgium
Site Reference ID/Investigator# 31210
🇧🇪Beerse, Belgium
Site Reference ID/Investigator# 31171
🇧🇪Berchem, Belgium
Site Reference ID/Investigator# 31155
🇧🇪Dendermonde, Belgium
Site Reference ID/Investigator# 31234
🇧🇪Hasselt, Belgium
Site Reference ID/Investigator# 31177
🇧🇪Koksijde, Belgium
Site Reference ID/Investigator# 31185
🇧🇪Liege, Belgium
Site Reference ID/Investigator# 31207
🇧🇪Liege, Belgium
Site Reference ID/Investigator# 31238
🇧🇪Schoten, Belgium
Site Reference ID/Investigator# 31217
🇧🇪Brasschaat, Belgium
Site Reference ID/Investigator# 31129
🇧🇪Court St. Etienne, Belgium
Site Reference ID/Investigator# 31126
🇧🇪Dilbeek, Belgium
Site Reference ID/Investigator# 31166
🇧🇪Erpent, Belgium
Site Reference ID/Investigator# 31188
🇧🇪Falmagne, Belgium
Site Reference ID/Investigator# 31183
🇧🇪Genk, Belgium
Site Reference ID/Investigator# 46502
🇧🇪Gent, Belgium
Site Reference ID/Investigator# 31181
🇧🇪Izegem, Belgium
Site Reference ID/Investigator# 31121
🇧🇪Alken, Belgium
Site Reference ID/Investigator# 31191
🇧🇪Hamme, Belgium
Site Reference ID/Investigator# 31233
🇧🇪Brussels, Belgium
Site Reference ID/Investigator# 31192
🇧🇪Esneux, Belgium
Site Reference ID/Investigator# 31173
🇧🇪Genk-Waterschei, Belgium
Site Reference ID/Investigator# 31228
🇧🇪Gent, Belgium
Site Reference ID/Investigator# 31117
🇧🇪Bruxelles, Belgium
Site Reference ID/Investigator# 31160
🇧🇪Dworp, Belgium
Site Reference ID/Investigator# 31226
🇧🇪Huy, Belgium
Site Reference ID/Investigator# 31149
🇧🇪Knokke, Belgium
Site Reference ID/Investigator# 31243
🇧🇪Lommel, Belgium
Site Reference ID/Investigator# 31139
🇧🇪Marcq, Belgium
Site Reference ID/Investigator# 31157
🇧🇪St. Truiden, Belgium
Site Reference ID/Investigator# 31182
🇧🇪Tielt, Belgium
Site Reference ID/Investigator# 31221
🇱🇺Bascharage, Luxembourg
Site Reference ID/Investigator# 31205
🇧🇪Braine-Le-Chateau, Belgium
Site Reference ID/Investigator# 31208
🇧🇪Damme, Belgium
Site Reference ID/Investigator# 31116
🇧🇪Dworp, Belgium
Site Reference ID/Investigator# 31124
🇧🇪Halle, Belgium
Site Reference ID/Investigator# 31206
🇧🇪Mol, Belgium
Site Reference ID/Investigator# 31153
🇧🇪Mons, Belgium
Site Reference ID/Investigator# 31258
🇧🇪Nivelles, Belgium
Site Reference ID/Investigator# 31229
🇧🇪Ragnies, Belgium
Site Reference ID/Investigator# 31180
🇧🇪Rumbeke, Belgium
Site Reference ID/Investigator# 31220
🇧🇪Schoten, Belgium
Site Reference ID/Investigator# 31240
🇧🇪Sint Niklaas, Belgium
Site Reference ID/Investigator# 31151
🇧🇪Tournai, Belgium
Site Reference ID/Investigator# 31122
🇧🇪Roeselare, Belgium
Site Reference ID/Investigator# 31147
🇧🇪S. Gravenwezel, Belgium
Site Reference ID/Investigator# 31215
🇧🇪Saint Ghislain, Belgium
Site Reference ID/Investigator# 31193
🇧🇪Villers-Saint-Simeon, Belgium
Site Reference ID/Investigator# 31231
🇱🇺Luxembourg, Luxembourg
Site Reference ID/Investigator# 31142
🇧🇪Seneffe, Belgium
Site Reference ID/Investigator# 31213
🇧🇪Sirault, Belgium
Site Reference ID/Investigator# 31150
🇧🇪St Denis, Belgium
Site Reference ID/Investigator# 31248
🇧🇪Tilff, Belgium
Site Reference ID/Investigator# 31254
🇧🇪Uccle, Belgium
Site Reference ID/Investigator# 31172
🇱🇺Esch-sur-Alzette, Luxembourg
Site Reference ID/Investigator# 31120
🇧🇪Sint Truiden, Belgium
Site Reference ID/Investigator# 31230
🇧🇪Sint-Genesius-Rode, Belgium
Site Reference ID/Investigator# 31165
🇧🇪Veerle, Belgium
Site Reference ID/Investigator# 31162
🇱🇺Ettelbruck, Luxembourg
Site Reference ID/Investigator# 31145
🇧🇪Waregem, Belgium