Clinical trial NCT01081873: Study to Document Treatment Patterns and to Evaluate Leuprolide and Alternative Therapeutic Approaches to the Treatments of Advanced Prostate Cancer
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 type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Prostatic Neoplasm
Keywords: Multicenter study
Lead sponsor: Abbott
Sponsor class: INDUSTRY
First posted: 2010-03-05
Enrollment: 2717
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Urologists

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.


Eligibility 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).

Primary outcomes:
measure: Effectiveness Parameter for Staging of Prostate Cancer: Metastases at Each Visit
timeFrame: time 0 (Baseline), month 3, and every 3 months until disease progression or up to 24 months, whichever came first
measure: Effectiveness Parameter for Screening or Recurrence of Prostate Cancer: Mean Prostate-specific Antigen (PSA) at Each Visit
timeFrame: time 0 (Baseline), month 3, and every 3 months until disease progression or up to 24 months, whichever came first
measure: Effectiveness Parameter: the Number of Participants With a Complete or Partial Response, Stable Disease, or Progressive Disease Following Treatment at Each Visit
timeFrame: month 3, and every 3 months until disease progression or up to 24 months, whichever came first
measure: 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
timeFrame: time 0 (Baseline), month 3, and every 3 months thereafter until disease progression or up to 24 months, whichever came first
measure: 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.
timeFrame: time 0 (Baseline), month 3, and every 3 months until disease progression or up to 24 months, whichever came first
Secondary outcomes:
measure: Safety Parameter: Number of Participants Reporting Serious Adverse Events (SAEs)
timeFrame: Baseline to disease progression or 24 months, whichever came first
measure: Epidemiological Data: Mean Weight
timeFrame: at time 0 (Baseline)
measure: Epidemiological Data: Mean Age
timeFrame: at time 0 (Baseline)
measure: Epidemiological Data: Race
timeFrame: at time 0 (Baseline)
measure: 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.
timeFrame: at time 0 (Baseline)
measure: Epidemiological Data: PSA at Baseline
timeFrame: at time 0 (Baseline)
measure: Epidemiological Data: Tumor Staging (Positive or Negative) Via a Rectal Examination, Prostate Biopsy, Echograph, or Magnetic Resonance Imaging (MRI) Test.
timeFrame: at time 0 (Baseline)
measure: Epidemiological Data: the Number of Participants With Tumor Stages T0, T1, T2, T3, and T4.
timeFrame: at time 0 (Baseline)
measure: Epidemiological Data: Node Staging - the Number of Participants With a Positive or Negative Computerized Tomography (CT) Scan or Magnetic Resonance Imaging (MRI) Test
timeFrame: at time 0 (Baseline)
measure: Epidemiological Data: Node Staging - the Number of Participants With a N0 or N1 Stage at Baseline.
timeFrame: at time 0 (Baseline)
measure: Epidemiological Data: Bone Scan at Baseline
timeFrame: at time 0 (Baseline)
measure: Epidemiological Data: Metastasis Staging (M0 or M1) at Baseline
timeFrame: at time 0 (Baseline)
Other outcomes:
Locations:
city: Aartselaar
country: Belgium
facility: Site Reference ID/Investigator# 31196
city: Afsnee
country: Belgium
facility: Site Reference ID/Investigator# 31237
city: Alken
country: Belgium
facility: Site Reference ID/Investigator# 31121
city: Antwerpen
country: Belgium
facility: Site Reference ID/Investigator# 31170
city: Antwerpen
country: Belgium
facility: Site Reference ID/Investigator# 31194
city: Antwerp
country: Belgium
facility: Site Reference ID/Investigator# 4872
city: Antwerp
country: Belgium
facility: Site Reference ID/Investigator# 31186
city: Arlon
country: Belgium
facility: Site Reference ID/Investigator# 31141
city: Arlon
country: Belgium
facility: Site Reference ID/Investigator# 31199
city: Ath
country: Belgium
facility: Site Reference ID/Investigator# 31247
city: Baulers
country: Belgium
facility: Site Reference ID/Investigator# 31190
city: Beerse
country: Belgium
facility: Site Reference ID/Investigator# 31210
city: Berchem
country: Belgium
facility: Site Reference ID/Investigator# 31171
city: Berlaar
country: Belgium
facility: Site Reference ID/Investigator# 31137
city: Beveren
country: Belgium
facility: Site Reference ID/Investigator# 31204
city: Boutersem
country: Belgium
facility: Site Reference ID/Investigator# 31184
city: Braine-Le-Chateau
country: Belgium
facility: Site Reference ID/Investigator# 31205
city: Brasschaat
country: Belgium
facility: Site Reference ID/Investigator# 31217
city: Bruges
country: Belgium
facility: Site Reference ID/Investigator# 31133
city: Bruges
country: Belgium
facility: Site Reference ID/Investigator# 31135
city: Brugge
country: Belgium
facility: Site Reference ID/Investigator# 31134
city: Brussels
country: Belgium
facility: Site Reference ID/Investigator# 31233
city: Brussels
country: Belgium
facility: Site Reference ID/Investigator# 31252
city: Brussels
country: Belgium
facility: Site Reference ID/Investigator# 31232
city: Bruxelles
country: Belgium
facility: Site Reference ID/Investigator# 31161
city: Bruxelles
country: Belgium
facility: Site Reference ID/Investigator# 31223
city: Bruxelles
country: Belgium
facility: Site Reference ID/Investigator# 31152
city: Bruxelles
country: Belgium
facility: Site Reference ID/Investigator# 31251
city: Bruxelles
country: Belgium
facility: Site Reference ID/Investigator# 31178
city: Bruxelles
country: Belgium
facility: Site Reference ID/Investigator# 31236
city: Bruxelles
country: Belgium
facility: Site Reference ID/Investigator# 31117
city: Bruxelles
country: Belgium
facility: Site Reference ID/Investigator# 31203
city: Bruxelles
country: Belgium
facility: Site Reference ID/Investigator# 31200
city: Court St. Etienne
country: Belgium
facility: Site Reference ID/Investigator# 31129
city: Cuesmes
country: Belgium
facility: Site Reference ID/Investigator# 31244
city: Damme
country: Belgium
facility: Site Reference ID/Investigator# 31208
city: Dendermonde
country: Belgium
facility: Site Reference ID/Investigator# 31155
city: Dendermonde
country: Belgium
facility: Site Reference ID/Investigator# 31197
city: Diest
country: Belgium
facility: Site Reference ID/Investigator# 31189
city: Dilbeek
country: Belgium
facility: Site Reference ID/Investigator# 31126
city: Dworp
country: Belgium
facility: Site Reference ID/Investigator# 31116
city: Dworp
country: Belgium
facility: Site Reference ID/Investigator# 31160
city: Elingen
country: Belgium
facility: Site Reference ID/Investigator# 31179
city: Embourg
country: Belgium
facility: Site Reference ID/Investigator# 31249
city: Erpent
country: Belgium
facility: Site Reference ID/Investigator# 31166
city: Esneux
country: Belgium
facility: Site Reference ID/Investigator# 31192
city: Falmagne
country: Belgium
facility: Site Reference ID/Investigator# 31188
city: Feluy
country: Belgium
facility: Site Reference ID/Investigator# 31195
city: Floreffe
country: Belgium
facility: Site Reference ID/Investigator# 31250
city: Genk-Waterschei
country: Belgium
facility: Site Reference ID/Investigator# 31173
city: Genk
country: Belgium
facility: Site Reference ID/Investigator# 31183
city: Gent
country: Belgium
facility: Site Reference ID/Investigator# 31228
city: Gent
country: Belgium
facility: Site Reference ID/Investigator# 46502
city: Gouy-Les-Pietons
country: Belgium
facility: Site Reference ID/Investigator# 31132
city: Halle
country: Belgium
facility: Site Reference ID/Investigator# 31124
city: Hamme
country: Belgium
facility: Site Reference ID/Investigator# 31191
city: Hasselt
country: Belgium
facility: Site Reference ID/Investigator# 31234
city: Heusy
country: Belgium
facility: Site Reference ID/Investigator# 31227
city: Hofstade
country: Belgium
facility: Site Reference ID/Investigator# 31212
city: Hove
country: Belgium
facility: Site Reference ID/Investigator# 31143
city: Huy
country: Belgium
facility: Site Reference ID/Investigator# 31226
city: Izegem
country: Belgium
facility: Site Reference ID/Investigator# 31119
city: Izegem
country: Belgium
facility: Site Reference ID/Investigator# 31181
city: Knokke
country: Belgium
facility: Site Reference ID/Investigator# 31149
city: Koksijde
country: Belgium
facility: Site Reference ID/Investigator# 31177
city: Kortrijk
country: Belgium
facility: Site Reference ID/Investigator# 31253
city: Lasne
country: Belgium
facility: Site Reference ID/Investigator# 31130
city: Lennik
country: Belgium
facility: Site Reference ID/Investigator# 31159
city: Leper
country: Belgium
facility: Site Reference ID/Investigator# 31123
city: Leper
country: Belgium
facility: Site Reference ID/Investigator# 31241
city: Lesves
country: Belgium
facility: Site Reference ID/Investigator# 31255
city: Leuven
country: Belgium
facility: Site Reference ID/Investigator# 31259
city: Libramont
country: Belgium
facility: Site Reference ID/Investigator# 31219
city: Liege
country: Belgium
facility: Site Reference ID/Investigator# 31128
city: Liege
country: Belgium
facility: Site Reference ID/Investigator# 31144
city: Liege
country: Belgium
facility: Site Reference ID/Investigator# 31185
city: Liege
country: Belgium
facility: Site Reference ID/Investigator# 31207
city: Liege
country: Belgium
facility: Site Reference ID/Investigator# 31245
city: Lier
country: Belgium
facility: Site Reference ID/Investigator# 31224
city: Lommel
country: Belgium
facility: Site Reference ID/Investigator# 31243
city: Marcinelle
country: Belgium
facility: Site Reference ID/Investigator# 31225
city: Marcq
country: Belgium
facility: Site Reference ID/Investigator# 31139
city: Mol
country: Belgium
facility: Site Reference ID/Investigator# 31206
city: Mons
country: Belgium
facility: Site Reference ID/Investigator# 31153
city: Mons
country: Belgium
facility: Site Reference ID/Investigator# 31257
city: Mont-sur-Marchienne
country: Belgium
facility: Site Reference ID/Investigator# 31140
city: Mortsel
country: Belgium
facility: Site Reference ID/Investigator# 31222
city: Namur
country: Belgium
facility: Site Reference ID/Investigator# 31164
city: Nivelles
country: Belgium
facility: Site Reference ID/Investigator# 31258
city: Oordegem
country: Belgium
facility: Site Reference ID/Investigator# 31218
city: Oostende
country: Belgium
facility: Site Reference ID/Investigator# 31214
city: Oostende
country: Belgium
facility: Site Reference ID/Investigator# 31242
city: Oosterzele
country: Belgium
facility: Site Reference ID/Investigator# 31156
city: Ottignies
country: Belgium
facility: Site Reference ID/Investigator# 31131
city: Oudenaarde
country: Belgium
facility: Site Reference ID/Investigator# 31163
city: Overijse
country: Belgium
facility: Site Reference ID/Investigator# 31125
city: Pollinkhove
country: Belgium
facility: Site Reference ID/Investigator# 31198
city: Ragnies
country: Belgium
facility: Site Reference ID/Investigator# 31229
city: Rijmenam
country: Belgium
facility: Site Reference ID/Investigator# 31138
city: Roeselare
country: Belgium
facility: Site Reference ID/Investigator# 31122
city: Roeslare
country: Belgium
facility: Site Reference ID/Investigator# 31174
city: Rotselaar
country: Belgium
facility: Site Reference ID/Investigator# 31136
city: Rumbeke
country: Belgium
facility: Site Reference ID/Investigator# 31180
city: S. Gravenwezel
country: Belgium
facility: Site Reference ID/Investigator# 31147
city: Saint Ghislain
country: Belgium
facility: Site Reference ID/Investigator# 31215
city: Saintes
country: Belgium
facility: Site Reference ID/Investigator# 31176
city: Schilde
country: Belgium
facility: Site Reference ID/Investigator# 31168
city: Schoten
country: Belgium
facility: Site Reference ID/Investigator# 31220
city: Schoten
country: Belgium
facility: Site Reference ID/Investigator# 31238
city: Seneffe
country: Belgium
facility: Site Reference ID/Investigator# 31142
city: Seraing
country: Belgium
facility: Site Reference ID/Investigator# 31158
city: Silly
country: Belgium
facility: Site Reference ID/Investigator# 31246
city: Sint Niklaas
country: Belgium
facility: Site Reference ID/Investigator# 31240
city: Sint Truiden
country: Belgium
facility: Site Reference ID/Investigator# 31120
city: Sint-Genesius-Rode
country: Belgium
facility: Site Reference ID/Investigator# 31230
city: Sirault
country: Belgium
facility: Site Reference ID/Investigator# 31213
city: St Denis
country: Belgium
facility: Site Reference ID/Investigator# 31150
city: St. Truiden
country: Belgium
facility: Site Reference ID/Investigator# 31157
city: Tielt
country: Belgium
facility: Site Reference ID/Investigator# 31182
city: Tilff
country: Belgium
facility: Site Reference ID/Investigator# 31248
city: Tournai
country: Belgium
facility: Site Reference ID/Investigator# 31151
city: Tremelo
country: Belgium
facility: Site Reference ID/Investigator# 31146
city: Uccle
country: Belgium
facility: Site Reference ID/Investigator# 31254
city: Uccle
country: Belgium
facility: Site Reference ID/Investigator# 31256
city: Veerle
country: Belgium
facility: Site Reference ID/Investigator# 31165
city: Villers-Saint-Simeon
country: Belgium
facility: Site Reference ID/Investigator# 31193
city: Wanze
country: Belgium
facility: Site Reference ID/Investigator# 31175
city: Waregem
country: Belgium
facility: Site Reference ID/Investigator# 31145
city: Wilrijk
country: Belgium
facility: Site Reference ID/Investigator# 31202
city: Woluwe St Pierre
country: Belgium
facility: Site Reference ID/Investigator# 31201
city: Xhendelesse
country: Belgium
facility: Site Reference ID/Investigator# 31216
city: Bascharage
country: Luxembourg
facility: Site Reference ID/Investigator# 31221
city: Esch-sur-Alzette
country: Luxembourg
facility: Site Reference ID/Investigator# 31172
city: Ettelbruck
country: Luxembourg
facility: Site Reference ID/Investigator# 31162
city: Luxembourg
country: Luxembourg
facility: Site Reference ID/Investigator# 31231
Study officials:
affiliation: Abbott
name: Simonne Lens
role: STUDY_DIRECTOR
References: