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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
History of Changes
Results First Received: December 22, 2011  
Study Type: Observational
Study Design: Observational Model: Case-Only;   Time Perspective: Prospective
Condition: Prostatic Neoplasm
Intervention: Drug: leuprolide (Lucrin/Lucrin-Tri-depot)

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Advanced Prostate Cancer Participants Participants with advanced prostate cancer treated with Lucrin /Lucrin- Tri-depot (leuprolide) or any other treatment with local reimbursement guidelines. No Baseline data was available for 3 patients who were thus excluded from all analyses.

Participant Flow:   Overall Study
    Advanced Prostate Cancer Participants  
STARTED     2714 [1]
COMPLETED     2416  
NOT COMPLETED     298  
Death                 86  
Withdrawal by Subject                 10  
Lost to Follow-up                 142  
Progression of prostate cancer                 13  
Unknown                 47  
[1] 3 patients were excluded from this and all analyses due to no available data from Baseline.



  Baseline Characteristics
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Reporting Groups
  Description
Advanced Prostate Cancer Participants Participants with advanced prostate cancer treated with Lucrin /Lucrin- Tri-depot (leuprolide) or any other treatment with local reimbursement guidelines. No Baseline data was available for 3 patients who were thus excluded from all analyses. Age was available for 2,691 patients only; age was missing for 23 patients who were thus not included in the age results.

Baseline Measures
    Advanced Prostate Cancer Participants  
Number of Participants  
[units: participants]
 		  2714  
Age  
[units: years]
Median ( Full Range ) 		  76.18  
  ( 46.3 to 98.2 )  
Age  
[units: years]
Mean ± Standard Deviation 		  75.39  ± 7.92  
Gender  
[units: participants]
 		 
Female     0  
Male     2714  



  Outcome Measures
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1.  Primary:   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 ]
  Show Outcome Measure 1

2.  Primary:   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 ]
  Show Outcome Measure 2

3.  Primary:   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 ]
  Show Outcome Measure 3

4.  Primary:   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 ]
  Show Outcome Measure 4

5.  Primary:   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 ]
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6.  Secondary:   Safety Parameter: Number of Participants Reporting Serious Adverse Events (SAEs)   [ Time Frame: Baseline to disease progression or 24 months, whichever came first ]
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7.  Secondary:   Epidemiological Data: Mean Weight   [ Time Frame: at time 0 (Baseline) ]
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8.  Secondary:   Epidemiological Data: Mean Age   [ Time Frame: at time 0 (Baseline) ]
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9.  Secondary:   Epidemiological Data: Race   [ Time Frame: at time 0 (Baseline) ]
  Show Outcome Measure 9

10.  Secondary:   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) ]
  Show Outcome Measure 10

11.  Secondary:   Epidemiological Data: PSA at Baseline   [ Time Frame: at time 0 (Baseline) ]
  Show Outcome Measure 11

12.  Secondary:   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) ]
  Show Outcome Measure 12

13.  Secondary:   Epidemiological Data: the Number of Participants With Tumor Stages T0, T1, T2, T3, and T4.   [ Time Frame: at time 0 (Baseline) ]
  Show Outcome Measure 13

14.  Secondary:   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) ]
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15.  Secondary:   Epidemiological Data: Node Staging - the Number of Participants With a N0 or N1 Stage at Baseline.   [ Time Frame: at time 0 (Baseline) ]
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16.  Secondary:   Epidemiological Data: Bone Scan at Baseline   [ Time Frame: at time 0 (Baseline) ]
  Show Outcome Measure 16

17.  Secondary:   Epidemiological Data: Metastasis Staging (M0 or M1) at Baseline   [ Time Frame: at time 0 (Baseline) ]
  Show Outcome Measure 17


  Serious Adverse Events
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  Other Adverse Events
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Limitations and Caveats
Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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Results Point of Contact:  
Name/Title: Global Medical Services
Organization: Abbott
phone: 800-633-9110


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