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:
Abbott
Information provided by (Responsible Party):
Abbott
ClinicalTrials.gov Identifier:
NCT01081873
First received: February 27, 2010
Last updated: October 26, 2012
Last verified: October 2012
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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:
|
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01081873
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| 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 May 23, 2013