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

NCT01081873 | Completed Results

• 1 other identifier: PMOS-BELG-04-001
• Study Type: observational
• Target: 2,717
• Locations: 2 countries
• Sites: 135

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.

Conditions

Prostatic Neoplasm

Keywords

Multicenter study

Outcome Measures

Primary Outcomes (5)

• Effectiveness Parameter for Staging of Prostate Cancer: Metastases at Each Visit

  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

  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

  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

  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.

  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 Outcomes (12)

• Safety Parameter: Number of Participants Reporting Serious Adverse Events (SAEs)

  Baseline to disease progression or 24 months, whichever came first

• Epidemiological Data: Mean Weight

  at time 0 (Baseline)

• Epidemiological Data: Mean Age

  at time 0 (Baseline)

• Epidemiological Data: Race

  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.

  at time 0 (Baseline)

Study Arms (1)

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)

Interventions

leuprolide (Lucrin/Lucrin-Tri-depot) DRUG

Subcutaneous or intramuscular administration for all participants

Also known as: Lucrin, Lucrin-Tri-depot

Advanced prostate cancer participants

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Urologists

You may qualify if:

• 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.

You may not qualify if:

• Contraindications according to the Summary of Product Characteristics (SPC).

Sponsors & Collaborators

• Abbott: lead

Study Sites (135)

Site Reference ID/Investigator# 31147

's-Gravenwezel, B-2970, Belgium

Location

Site Reference ID/Investigator# 31196

Aartselaar, B-2630, Belgium

Location

Site Reference ID/Investigator# 31237

Afsnee, B-9051, Belgium

Location

Site Reference ID/Investigator# 31121

Alken, B-3570, Belgium

Location

Site Reference ID/Investigator# 31170

Antwerp, B-2018, Belgium

Location

Site Reference ID/Investigator# 31194

Antwerp, B-2018, Belgium

Location

Site Reference ID/Investigator# 4872

Antwerp, B-2020, Belgium

Location

Site Reference ID/Investigator# 31186

Antwerp, B-2050, Belgium

Location

Site Reference ID/Investigator# 31141

Arlon, B-6700, Belgium

Location

Site Reference ID/Investigator# 31199

Arlon, B-6700, Belgium

Location

Site Reference ID/Investigator# 31247

Ath, B-7804, Belgium

Location

Site Reference ID/Investigator# 31190

Baulers, B-1401, Belgium

Location

Site Reference ID/Investigator# 31210

Beerse, B-2340, Belgium

Location

Site Reference ID/Investigator# 31171

Berchem, B-2600, Belgium

Location

Site Reference ID/Investigator# 31137

Berlaar, B-2590, Belgium

Location

Site Reference ID/Investigator# 31204

Beveren, B-8800, Belgium

Location

Site Reference ID/Investigator# 31184

Boutersem, B-3370, Belgium

Location

Site Reference ID/Investigator# 31205

Braine-le-Château, B-1440, Belgium

Location

Site Reference ID/Investigator# 31217

Brasschaat, B-2930, Belgium

Location

Site Reference ID/Investigator# 31133

Bruges, B-8310, Belgium

Location

Site Reference ID/Investigator# 31134

Bruges, B-8310, Belgium

Location

Site Reference ID/Investigator# 31135

Bruges, B-8310, Belgium

Location

Site Reference ID/Investigator# 31233

Brussels, B-1000, Belgium

Location

Site Reference ID/Investigator# 31161

Brussels, B-1020, Belgium

Location

Site Reference ID/Investigator# 31223

Brussels, B-1030, Belgium

Location

Site Reference ID/Investigator# 31152

Brussels, B-1050, Belgium

Location

Site Reference ID/Investigator# 31251

Brussels, B-1081, Belgium

Location

Site Reference ID/Investigator# 31178

Brussels, B-1083, Belgium

Location

Site Reference ID/Investigator# 31236

Brussels, B-1090, Belgium

Location

Site Reference ID/Investigator# 31252

Brussels, B-1160, Belgium

Location

Site Reference ID/Investigator# 31117

Brussels, B-1180, Belgium

Location

Site Reference ID/Investigator# 31203

Brussels, B-1180, Belgium

Location

Site Reference ID/Investigator# 31232

Brussels, B-1200, Belgium

Location

Site Reference ID/Investigator# 31200

Brussels, B-1853, Belgium

Location

Site Reference ID/Investigator# 31129

Court-Saint-Étienne, B-1490, Belgium

Location

Site Reference ID/Investigator# 31244

Cuesmes, B-7033, Belgium

Location

Site Reference ID/Investigator# 31208

Damme, B-8340, Belgium

Location

Site Reference ID/Investigator# 31155

Dendermonde, B-9200, Belgium

Location

Site Reference ID/Investigator# 31197

Dendermonde, B-9200, Belgium

Location

Site Reference ID/Investigator# 31189

Diest, B-3290, Belgium

Location

Site Reference ID/Investigator# 31126

Dilbeek, B-1700, Belgium

Location

Site Reference ID/Investigator# 31116

Dworp, B-1653, Belgium

Location

Site Reference ID/Investigator# 31160

Dworp, B-1653, Belgium

Location

Site Reference ID/Investigator# 31179

Elingen, B-1671, Belgium

Location

Site Reference ID/Investigator# 31249

Embourg, B-4053, Belgium

Location

Site Reference ID/Investigator# 31166

Erpent, B-5101, Belgium

Location

Site Reference ID/Investigator# 31192

Esneux, B-4130, Belgium

Location

Site Reference ID/Investigator# 31188

Falmagne, B-5500, Belgium

Location

Site Reference ID/Investigator# 31195

Feluy, B-7181, Belgium

Location

Site Reference ID/Investigator# 31250

Floreffe, B-5150, Belgium

Location

Site Reference ID/Investigator# 31183

Genk, B-3600, Belgium

Location

Site Reference ID/Investigator# 31173

Genk-Waterschei, B-3600, Belgium

Location

Site Reference ID/Investigator# 31228

Ghent, B-9000, Belgium

Location

Site Reference ID/Investigator# 46502

Ghent, B-9000, Belgium

Location

Site Reference ID/Investigator# 31132

Gouy-Les-Pietons, B-6181, Belgium

Location

Site Reference ID/Investigator# 31124

Halle, B-1500, Belgium

Location

Site Reference ID/Investigator# 31191

Hamme, B-9220, Belgium

Location

Site Reference ID/Investigator# 31234

Hasselt, B-3510, Belgium

Location

Site Reference ID/Investigator# 31227

Heusy, B-4802, Belgium

Location

Site Reference ID/Investigator# 31212

Hofstade, B-1981, Belgium

Location

Site Reference ID/Investigator# 31143

Hove, B-2540, Belgium

Location

Site Reference ID/Investigator# 31226

Huy, B-4500, Belgium

Location

Site Reference ID/Investigator# 31119

Izegem, B-8870, Belgium

Location

Site Reference ID/Investigator# 31181

Izegem, B-8870, Belgium

Location

Site Reference ID/Investigator# 31149

Knokke, B-8300, Belgium

Location

Site Reference ID/Investigator# 31177

Koksijde, B-8670, Belgium

Location

Site Reference ID/Investigator# 31253

Kortrijk, B-8500, Belgium

Location

Site Reference ID/Investigator# 31130

Lasne, B-1380, Belgium

Location

Site Reference ID/Investigator# 31159

Lennik, B-1750, Belgium

Location

Site Reference ID/Investigator# 31123

Leper, B-8900, Belgium

Location

Site Reference ID/Investigator# 31241

Leper, B-8900, Belgium

Location

Site Reference ID/Investigator# 31255

Lesves, B-1380, Belgium

Location

Site Reference ID/Investigator# 31259

Leuven, 3000, Belgium

Location

Site Reference ID/Investigator# 31219

Libramont, B-6800, Belgium

Location

Site Reference ID/Investigator# 31224

Lier, B2400, Belgium

Location

Site Reference ID/Investigator# 31128

Liège, B-4000, Belgium

Location

Site Reference ID/Investigator# 31144

Liège, B-4000, Belgium

Location

Site Reference ID/Investigator# 31185

Liège, B-4000, Belgium

Location

Site Reference ID/Investigator# 31207

Liège, B-4000, Belgium

Location

Site Reference ID/Investigator# 31245

Liège, B-4000, Belgium

Location

Site Reference ID/Investigator# 31243

Lommel, B-3920, Belgium

Location

Site Reference ID/Investigator# 31225

Marcinelle, B-6001, Belgium

Location

Site Reference ID/Investigator# 31139

Mark, B-7850, Belgium

Location

Site Reference ID/Investigator# 31206

Mol, B-2400, Belgium

Location

Site Reference ID/Investigator# 31153

Mons, B-7000, Belgium

Location

Site Reference ID/Investigator# 31257

Mons, B-7000, Belgium

Location

Site Reference ID/Investigator# 31140

Mont-sur-Marchienne, B-6032, Belgium

Location

Site Reference ID/Investigator# 31222

Mortsel, B2640, Belgium

Location

Site Reference ID/Investigator# 31164

Namur, B-5000, Belgium

Location

Site Reference ID/Investigator# 31258

Nivelles, B-1400, Belgium

Location

Site Reference ID/Investigator# 31218

Oordegem, B-9340, Belgium

Location

Site Reference ID/Investigator# 31156

Oosterzele, B-9860, Belgium

Location

Site Reference ID/Investigator# 31214

Ostend, B-8400, Belgium

Location

Site Reference ID/Investigator# 31242

Ostend, B-8400, Belgium

Location

Site Reference ID/Investigator# 31131

Ottignies, B-1340, Belgium

Location

Site Reference ID/Investigator# 31163

Oudenaarde, B-9700, Belgium

Location

Site Reference ID/Investigator# 31125

Overijse, B-3090, Belgium

Location

Site Reference ID/Investigator# 31198

Pollinkhove, B-8647, Belgium

Location

Site Reference ID/Investigator# 31229

Ragnies, B-6532, Belgium

Location

Site Reference ID/Investigator# 31138

Rijmenam, B-2820, Belgium

Location

Site Reference ID/Investigator# 31122

Roeselare, B-8800, Belgium

Location

Site Reference ID/Investigator# 31174

Roeslare, B-8800, Belgium

Location

Site Reference ID/Investigator# 31136

Rotselaar, B-3110, Belgium

Location

Site Reference ID/Investigator# 31180

Rumbeke, B-8800, Belgium

Location

Site Reference ID/Investigator# 31157

Saint Truiden, B-3800, Belgium

Location

Site Reference ID/Investigator# 31150

Saint-Denis, B-7034, Belgium

Location

Site Reference ID/Investigator# 31215

Saint-Ghislain, B-7330, Belgium

Location

Site Reference ID/Investigator# 31176

Saintes, B-1480, Belgium

Location

Site Reference ID/Investigator# 31168

Schilde, B-2970, Belgium

Location

Site Reference ID/Investigator# 31220

Schoten, B-2900, Belgium

Location

Site Reference ID/Investigator# 31238

Schoten, B-2900, Belgium

Location

Site Reference ID/Investigator# 31142

Seneffe, B-7180, Belgium

Location

Site Reference ID/Investigator# 31158

Seraing, B-4100, Belgium

Location

Site Reference ID/Investigator# 31246

Silly, B-7830, Belgium

Location

Site Reference ID/Investigator# 31230

Sint-Genesius-Rode, B-1640, Belgium

Location

Site Reference ID/Investigator# 31240

Sint-Niklaas, B-9100, Belgium

Location

Site Reference ID/Investigator# 31120

Sint-Truiden, B-3800, Belgium

Location

Site Reference ID/Investigator# 31213

Sirault, B-7332, Belgium

Location

Site Reference ID/Investigator# 31182

Tielt, B-8700, Belgium

Location

Site Reference ID/Investigator# 31248

Tilff, B-4130, Belgium

Location

Site Reference ID/Investigator# 31151

Tournai, B-7500, Belgium

Location

Site Reference ID/Investigator# 31146

Tremelo, B-3120, Belgium

Location

Site Reference ID/Investigator# 31254

Uccle, B-1180, Belgium

Location

Site Reference ID/Investigator# 31256

Uccle, B-1180, Belgium

Location

Site Reference ID/Investigator# 31165

Veerle, B-2431, Belgium

Location

Site Reference ID/Investigator# 31193

Villers-Saint-Siméon, B-4453, Belgium

Location

Site Reference ID/Investigator# 31175

Wanze, B-4520, Belgium

Location

Site Reference ID/Investigator# 31145

Waregem, B-8790, Belgium

Location

Site Reference ID/Investigator# 31202

Wilrijk, B-2610, Belgium

Location

Site Reference ID/Investigator# 31201

Woluwe-Saint-Pierre - Sint-Pieters-Woluwe, B-1150, Belgium

Location

Site Reference ID/Investigator# 31216

Xhendelesse, B-4652, Belgium

Location

Site Reference ID/Investigator# 31221

Bascharage, L-4918, Luxembourg

Location

Site Reference ID/Investigator# 31172

Esch-sur-Alzette, L-4243, Luxembourg

Location

Site Reference ID/Investigator# 31162

Ettelbruck, L-9002, Luxembourg

Location

Site Reference ID/Investigator# 31231

Luxembourg, L-2540, Luxembourg

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Leuprolide

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Gonadotropin-Releasing Hormone; Pituitary Hormone-Releasing Hormones; Hypothalamic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Neuropeptides; Peptides; Amino Acids, Peptides, and Proteins; Oligopeptides; Nerve Tissue Proteins; Proteins

Results Point of Contact

• Title: Global Medical Services
• Organization: Abbott

800-633-9110

Study Officials

• Simonne Lens

  Abbott

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 27, 2010
• First Posted: March 5, 2010
• Study Start: June 1, 2004
• Primary Completion: December 1, 2010
• Study Completion: December 1, 2010
• Last Updated: October 31, 2012
• Results First Posted: March 26, 2012

Record last verified: 2012-10

Locations

BE (131); LU (4)