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
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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 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 ]

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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. ]

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3. Secondary:

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

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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. ]

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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 ]

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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:

	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.
	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.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed. Restriction Description: Abbott requests that any investigator or institution that plans on presenting/publishing results disclosure, provide written notification of their request 60 days prior to their presentation/publication. Abbott requests that no presentation/publication will be instituted until 12 months after a study is completed, or after the first presentation/publication whichever occurs first. A delay may be proposed of a presentation/publication if Abbott needs to secure patent or proprietary protection

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: 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

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