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Lucrin® Depot Efficacy and Safety Monitoring Study in Patients With Advanced Prostate Cancer and Lower Urinary Tract Symptoms (LUTS) (LEMON)

This study has been completed.
Sponsor:
Collaborators:
Fraktal.com.pl
Med-net.pl
Information provided by (Responsible Party):
Abbott
ClinicalTrials.gov Identifier:
NCT01078545
First received: February 28, 2010
Last updated: January 12, 2012
Last verified: January 2012
History of Changes
Results First Received: November 29, 2011  
Study Type: Observational
Study Design: Observational Model: Case-Only;   Time Perspective: Prospective
Conditions: Advanced Prostate Cancer
Lower Urinary Tract Symptoms
Intervention: Drug: Leuprolide acetate Depot Susp. 11.25 mg (Poland), 3.75 mg (Ukraine)

  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
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Advanced PCa Patients With LUTS Treated With GnRH Analogue Patients with advanced prostate cancer (PCa) and lower urinary tract symptoms (LUTS) treated with GnRH analogue Lucrin Depot 11.25 mg (Lucrin Depot 3.75mg - in Ukraine)

Participant Flow:   Overall Study
    Advanced PCa Patients With LUTS Treated With GnRH Analogue  
STARTED     729  
Intent-to-treat Population     729  
Per Protocol Population     661  
COMPLETED     703  
NOT COMPLETED     26  
Lost to Follow-up                 13  
Physician Decision                 6  
Withdrawal by Subject                 3  
Death                 3  
Participant moved to another physician                 1  



  Baseline Characteristics
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Reporting Groups
  Description
Advanced PCa Patients With LUTS Treated With GnRH Analogue Patients with advanced prostate cancer (PCa) and lower urinary tract symptoms (LUTS) treated with GnRH analogue Lucrin Depot 11.25 mg (Lucrin Depot 3.75mg - in Ukraine)

Baseline Measures
    Advanced PCa Patients With LUTS Treated With GnRH Analogue  
Number of Participants  
[units: participants]
 		  729  
Age  
[units: years]
Mean ± Standard Deviation 		  71.2  ± 7.2  
Gender  
[units: participants]
 		 
Female     0  
Male     729  
Region of Enrollment  
[units: participants]
 		 
Poland     659  
Ukraine     70  
Age at diagnosis of prostate cancer [1]
[units: years]
Mean ± Standard Deviation 		  70.7  ± 7.1  
Prostate-Specific Antigen (PSA) concentration [2]
[units: ng/mL]
Mean ± Standard Deviation 		  55.8  ± 291.5  
Prostate cancer type  
[units: Participants]
 		 
Locally advanced     562  
Advanced with metastases     127  
Localized     39  
Lack of data     1  
Gleason score [3]
[units: participants]
 		 
2     1  
3     3  
4     35  
5     53  
6     151  
7     262  
8     167  
9     41  
10     13  
Lack of data     3  
[1] Age of participant when diagnosed with prostate cancer. Results based on 724 participants.
[2] The mean prostate-specific antigen (PSA) concentration at Baseline. Results based on 718 participants.
[3] The Gleason score classifies each participant's prostate cancer based on how the cells look under the microscope. Prostate cancers often have areas with different grades, so a grade is assigned to the 2 areas that make up most of the cancer. The Gleason score is the sum of these 2 grades, resulting in a number from 2 to 10. The higher the Gleason score the more likely it is that the cancer will grow faster and spread beyond the prostate.



  Outcome Measures
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1.  Primary:   The Change in the International Prostate Symptom Score (IPSS) From Baseline to Month 12. The IPSS Has a Range From 0 to 35.   [ Time Frame: Baseline to 12 months ]

Measure Type Primary
Measure Title The Change in the International Prostate Symptom Score (IPSS) From Baseline to Month 12. The IPSS Has a Range From 0 to 35.
Measure Description The International Prostate Symptom Score (IPSS) is used to assess the severity of lower urinary tract symptoms (LUTS) and to monitor disease progression. The IPSS is calculated from 7 questions regarding incomplete emptying, frequency, intermittency, urgency, weak stream, and straining [rated as 0 (not at all) to 5 (almost always)], as well as how many times on average a participant has to get up to urinate at night (0=none to 5=5 times or more). The total score is classified as follows: 0 to 7 = mildly symptomatic; 8 to 19 = moderately symptomatic; and 20 to 35 = severely symptomatic.
Time Frame Baseline to 12 months  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Analysis conducted in the intent-to-treat population.

Reporting Groups
  Description
Advanced PCa Patients With LUTS Treated With GnRH Analogue Patients with advanced prostate cancer (PCa) and lower urinary tract symptoms (LUTS) treated with GnRH analogue Lucrin Depot 11.25 mg (Lucrin Depot 3.75mg - in Ukraine)

Measured Values
    Advanced PCa Patients With LUTS Treated With GnRH Analogue  
Number of Participants Analyzed  
[units: participants]
 		  729  
The Change in the International Prostate Symptom Score (IPSS) From Baseline to Month 12. The IPSS Has a Range From 0 to 35.  
[units: units on a scale]
Mean ± Standard Deviation 		 
IPSS at Baseline (n=727)     17.8  ± 6.9  
IPSS at 12 months (n=699)     10.0  ± 5.0  

No statistical analysis provided for The Change in the International Prostate Symptom Score (IPSS) From Baseline to Month 12. The IPSS Has a Range From 0 to 35.



2.  Secondary:   The Change in the International Prostate Symptom Score (IPSS) From Baseline to 3, 6, 9, and 12 Months.   [ Time Frame: Baseline to 3, 6, 9, and 12 months. ]

Measure Type Secondary
Measure Title The Change in the International Prostate Symptom Score (IPSS) From Baseline to 3, 6, 9, and 12 Months.
Measure Description The International Prostate Symptom Score (IPSS) is used to assess the severity of lower urinary tract symptoms (LUTS) and to monitor disease progression. The IPSS is calculated from 7 questions regarding incomplete emptying, frequency, intermittency, urgency, weak stream, and straining [rated as 0 (not at all) to 5 (almost always)], as well as how many times on average a participant has to get up to urinate at night (0=none to 5=5 times or more). The total score is classified as follows: 0 to 7 = mildly symptomatic; 8 to 19 = moderately symptomatic; and 20 to 35 = severely symptomatic.
Time Frame Baseline to 3, 6, 9, and 12 months.  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Analysis conducted in the intent-to-treat population.

Reporting Groups
  Description
Advanced PCa Patients With LUTS Treated With GnRH Analogue Patients with advanced prostate cancer (PCa) and lower urinary tract symptoms (LUTS) treated with GnRH analogue Lucrin Depot 11.25 mg (Lucrin Depot 3.75mg - in Ukraine)

Measured Values
    Advanced PCa Patients With LUTS Treated With GnRH Analogue  
Number of Participants Analyzed  
[units: participants]
 		  729  
The Change in the International Prostate Symptom Score (IPSS) From Baseline to 3, 6, 9, and 12 Months.  
[units: units on a scale]
Mean ± Standard Deviation 		 
IPSS at Baseline (n=727)     17.8  ± 6.9  
IPSS at month 3 (n=724)     14.0  ± 5.6  
IPSS at month 6 (n=717)     12.3  ± 5.1  
IPSS at month 9 (n=702)     10.9  ± 4.9  
IPSS at month 12 (n=699)     10.0  ± 5.0  

No statistical analysis provided for The Change in the International Prostate Symptom Score (IPSS) From Baseline to 3, 6, 9, and 12 Months.



3.  Secondary:   Percentage of Patients at Baseline With One of the Symptoms Connected With Prostate Cancer.   [ Time Frame: Baseline ]

Measure Type Secondary
Measure Title Percentage of Patients at Baseline With One of the Symptoms Connected With Prostate Cancer.
Measure Description Percentage of participants at baseline with one of the following symptoms connected with prostate cancer: hematospermia (blood in the sperm), lower abdominal pain, urine incontinence, erectile dysfunction, crotch pain, anal pain or bleeding, lumbar/back pain, bone pain, spinal compression symptoms, peripheral lymph node enlargement, and lymphatic oedema of lower extremities. The intensity of each symptom was rated by the participant from 1 (minimum) to 7 (maximum). Zero indicates that the symptom was not present.
Time Frame Baseline  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Analysis conducted in the intent-to-treat population.

Reporting Groups
  Description
Advanced PCa Patients With LUTS Treated With GnRH Analogue Patients with advanced prostate cancer (PCa) and lower urinary tract symptoms (LUTS) treated with GnRH analogue Lucrin Depot 11.25 mg (Lucrin Depot 3.75mg - in Ukraine)

Measured Values
    Advanced PCa Patients With LUTS Treated With GnRH Analogue  
Number of Participants Analyzed  
[units: participants]
 		  729  
Percentage of Patients at Baseline With One of the Symptoms Connected With Prostate Cancer.  
[units: Percentage of participants]
 		 
Hematospermia     3  
Lower abdominal pain     31  
Urine incontinence     13  
Erectile dysfunction     62  
Crotch pain     24  
Anal pain or bleeding     2  
Lumbar/back pain     15  
Bone pain     17  
Spinal compression symptoms     1  
Peripheral lymph node enlargement     2  
Lymphatic oedema of the lower extremities     6  

No statistical analysis provided for Percentage of Patients at Baseline With One of the Symptoms Connected With Prostate Cancer.



4.  Secondary:   Changes in the Intensity of Symptoms Connected With Prostate Cancer From Baseline to Month 3, 6, 9, and 12.   [ Time Frame: Baseline to 3, 6, 9, and 12 months. ]

Measure Type Secondary
Measure Title Changes in the Intensity of Symptoms Connected With Prostate Cancer From Baseline to Month 3, 6, 9, and 12.
Measure Description Changes in the intensity of the following symptoms connected with prostate cancer: hematospermia (blood in the sperm), lower abdominal pain, urine incontinence, erectile dysfunction, crotch pain, anal pain or bleeding, lumbar/back pain, bone pain, spinal compression symptoms, peripheral lymph node enlargement, and lymphatic oedema of lower extremities. The intensity of each symptom was rated by the participant from 1 (minimum) to 7 (maximum). Zero indicates that the symptom was not present.
Time Frame Baseline to 3, 6, 9, and 12 months.  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Analysis conducted in the intent-to-treat population.

Reporting Groups
  Description
Advanced PCa Patients With LUTS Treated With GnRH Analogue Patients with advanced prostate cancer (PCa) and lower urinary tract symptoms (LUTS) treated with GnRH analogue Lucrin Depot 11.25 mg (Lucrin Depot 3.75mg - in Ukraine)

Measured Values
    Advanced PCa Patients With LUTS Treated With GnRH Analogue  
Number of Participants Analyzed  
[units: participants]
 		  729  
Changes in the Intensity of Symptoms Connected With Prostate Cancer From Baseline to Month 3, 6, 9, and 12.  
[units: Units on a scale]
Median ( Full Range ) 		 
Hematospermia (Baseline; n=729)     0  
  ( 0 to 5 )  
>Month 3 (n=726)     0  
  ( 0 to 4 )  
>Month 6 (n=719)     0  
  ( 0 to 4 )  
>Month 9 (n=704)     0  
  ( 0 to 5 )  
>Month 12 (n=703)     0  
  ( 0 to 3 )  
Lower abdominal pain (Baseline; n=729)     0  
  ( 0 to 7 )  
>Month 3 (n=726)     0  
  ( 0 to 7 )  
>Month 6 (n=719)     0  
  ( 0 to 6 )  
>Month 9 (n=704)     0  
  ( 0 to 6 )  
>Month 12 (n=703)     0  
  ( 0 to 7 )  
Urinary incontinence (Baseline; n=729)     0  
  ( 0 to 7 )  
>Month 3 (n=726)     0  
  ( 0 to 7 )  
>Month 6 (n=719)     0  
  ( 0 to 7 )  
>Month 9 (n=704)     0  
  ( 0 to 7 )  
>Month 12 (n=703)     0  
  ( 0 to 7 )  
Erectile dysfunction (Baseline; n=729)     4  
  ( 0 to 7 )  
>Month 3 (n=726)     5  
  ( 0 to 7 )  
>Month 6 (n=719)     5  
  ( 0 to 7 )  
>Month 9 (n=704)     6  
  ( 0 to 7 )  
>Month 12 (n=703)     6  
  ( 0 to 7 )  
Crotch pain (Baseline; n=729)     0  
  ( 0 to 7 )  
>Month 3 (n=726)     0  
  ( 0 to 7 )  
>Month 6 (n=719)     0  
  ( 0 to 7 )  
>Month 9 (n=704)     0  
  ( 0 to 7 )  
>Month 12 (n=703)     0  
  ( 0 to 7 )  
Anal pain or bleeding (Baseline; n=729)     0  
  ( 0 to 7 )  
>Month 3 (n=726)     0  
  ( 0 to 7 )  
>Month 6 (n=719)     0  
  ( 0 to 4 )  
>Month 9 (n=704)     0  
  ( 0 to 4 )  
>Month 12 (n=703)     0  
  ( 0 to 3 )  
Lumbar/back pain (Baseline n=729)     0  
  ( 0 to 7 )  
>Month 3 (n=726)     0  
  ( 0 to 5 )  
>Month 6 (n=719)     0  
  ( 0 to 6 )  
>Month 9 (n=704)     0  
  ( 0 to 6 )  
>Month 12 (n=703)     0  
  ( 0 to 6 )  
Bone pain (Baseline; n=729)     0  
  ( 0 to 7 )  
>Month 3 (n=726)     0  
  ( 0 to 7 )  
>Month 6 (n=719)     0  
  ( 0 to 7 )  
>Month 9 (n=704)     0  
  ( 0 to 7 )  
>Month 12 (n=703)     0  
  ( 0 to 7 )  
Spinal compression symptoms (Baseline; n=729)     0  
  ( 0 to 5 )  
>Month 3 (n=726)     0  
  ( 0 to 5 )  
>Month 6 (n=719)     0  
  ( 0 to 4 )  
>Month 9 (n=704)     0  
  ( 0 to 5 )  
>Month 12 (n=703)     0  
  ( 0 to 5 )  
Periph. lymph node enlargement (Baseline; n=729)     0  
  ( 0 to 7 )  
>Month 3 (n=726)     0  
  ( 0 to 7 )  
>Month 6 (n=719)     0  
  ( 0 to 6 )  
>Month 9 (n=704)     0  
  ( 0 to 6 )  
>Month 12 (n=703)     0  
  ( 0 to 6 )  
Lymphatic oedema, lower extrem. (Baseline; n=729)     0  
  ( 0 to 6 )  
>Month 3 (n=726)     0  
  ( 0 to 6 )  
>Month 6 (n=719)     0  
  ( 0 to 5 )  
>Month 9 (n=704)     0  
  ( 0 to 6 )  
>Month 12 (n=703)     0  
  ( 0 to 5 )  

No statistical analysis provided for Changes in the Intensity of Symptoms Connected With Prostate Cancer From Baseline to Month 3, 6, 9, and 12.



5.  Secondary:   Reported Adverse Events/Serious Adverse Events   [ Time Frame: Baseline to 12 months ]

Measure Type Secondary
Measure Title Reported Adverse Events/Serious Adverse Events
Measure Description Adverse events (AEs) were collected during the course of the study from the first visit (Baseline) through the last visit (12 months). The number of participants experiencing a non-serious or serious adverse event or both types of events are summarized. See the Reported Adverse Event section for details.
Time Frame Baseline to 12 months  
Safety Issue Yes  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Analysis conducted in the intent-to-treat population.

Reporting Groups
  Description
Advanced PCa Patients With LUTS Treated With GnRH Analogue Patients with advanced prostate cancer (PCa) and lower urinary tract symptoms (LUTS) treated with GnRH analogue Lucrin Depot 11.25 mg (Lucrin Depot 3.75mg - in Ukraine)

Measured Values
    Advanced PCa Patients With LUTS Treated With GnRH Analogue  
Number of Participants Analyzed  
[units: participants]
 		  729  
Reported Adverse Events/Serious Adverse Events  
[units: Participants]
 		 
Experienced a serious AE     5  
Experienced a non-serious AE     3  
Experienced both a serious AE and non-serious AE     1  

No statistical analysis provided for Reported Adverse Events/Serious Adverse Events




  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
No text entered.  


Results Point of Contact:  
Name/Title: Global Medical Services
Organization: Abbott
phone: 1-800-633-9110


No publications provided


Responsible Party: Abbott
ClinicalTrials.gov Identifier: NCT01078545     History of Changes
Other Study ID Numbers: P10-612
Study First Received: February 28, 2010
Results First Received: November 29, 2011
Last Updated: January 12, 2012
Health Authority: Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Ukraine: Ministry of Health