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

January 12, 2012 updated by: Abbott

Lucrin® Depot Efficacy and Safety Monitoring Study in Patients With Advanced Prostate Cancer and Lower Urinary Tract Symptoms. International, Multicenter Post-marketing Observational Study.

The purpose of the study is to determine the influence of GnRH (gonadotropin releasing hormone) analogue - Lucrin Depot 11.25 mg (Lucrin Depot 3.75mg - in Ukraine) administration on intensity of lower urinary tract symptoms (LUTS) in patients with diagnosed locally advanced and/or metastatic prostate cancer and LUTS.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The remaining target is:

- to assess the intensity of LUTS in Polish and Ukrainian patients with locally advanced and metastatic prostate cancer, previously untreated with hormonal therapy

Study Type

Observational

Enrollment (Actual)

729

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Poland
      • Belchatow, Poland, 97-400
        • Site Reference ID/Investigator# 31076
      • Bialystok, Poland, 11-300
        • Site Reference ID/Investigator# 31002
      • Bialystok, Poland, 15-027
        • Site Reference ID/Investigator# 30977
      • Bialystok, Poland, 15-161
        • Site Reference ID/Investigator# 31030
      • Bialystok, Poland, 15-201
        • Site Reference ID/Investigator# 31048
      • Bobrowniki, Poland, 42-583
        • Site Reference ID/Investigator# 31083
      • Brwinow, Poland, 05-840
        • Site Reference ID/Investigator# 30976
      • Bydgoszcz, Poland, 85-209
        • Site Reference ID/Investigator# 31028
      • Bytom, Poland, 41-902
        • Site Reference ID/Investigator# 31014
      • Bytom, Poland, 41-908
        • Site Reference ID/Investigator# 31006
      • Bytom, Poland, 41-933
        • Site Reference ID/Investigator# 31018
      • Ciechanow, Poland, 06-400
        • Site Reference ID/Investigator# 31007
      • Elblag, Poland, 82-300
        • Site Reference ID/Investigator# 31004
      • Elblag, Poland, 82-300
        • Site Reference ID/Investigator# 31090
      • Elk, Poland, 19-300
        • Site Reference ID/Investigator# 31044
      • Florentynow, Poland, 95-083
        • Site Reference ID/Investigator# 30994
      • Gdansk, Poland, 80-305
        • Site Reference ID/Investigator# 9803
      • Gdansk, Poland, 80-371
        • Site Reference ID/Investigator# 31057
      • Gdansk, Poland, 80-462
        • Site Reference ID/Investigator# 31101
      • Gdansk, Poland, 80-858
        • Site Reference ID/Investigator# 31097
      • Gliwice, Poland, 44-100
        • Site Reference ID/Investigator# 30984
      • Imielnik Stary, Poland, 95-010
        • Site Reference ID/Investigator# 31051
      • Inowroclaw, Poland, 88-100
        • Site Reference ID/Investigator# 31023
      • Inowroclaw, Poland, 88-100
        • Site Reference ID/Investigator# 31074
      • Jankowo, Poland, 80-180
        • Site Reference ID/Investigator# 31032
      • Jaroslawiec, Poland, 37-500
        • Site Reference ID/Investigator# 31067
      • Jastkow, Poland, 21-002
        • Site Reference ID/Investigator# 30995
      • Jastrzebie Zdroj, Poland, 44-330
        • Site Reference ID/Investigator# 31065
      • Jastrzebie Zdroj, Poland, 44-335
        • Site Reference ID/Investigator# 31031
      • Jelenia Gora, Poland, 58-500
        • Site Reference ID/Investigator# 31054
      • Katowice, Poland, 40-060
        • Site Reference ID/Investigator# 30997
      • Katowice, Poland, 40-683
        • Site Reference ID/Investigator# 31036
      • Kielce, Poland, 25-132
        • Site Reference ID/Investigator# 31055
      • Kielce, Poland, 25-372
        • Site Reference ID/Investigator# 30999
      • Kluczbork, Poland, 46-200
        • Site Reference ID/Investigator# 31102
      • Kolbudy, Poland, 83-83-050
        • Site Reference ID/Investigator# 31068
      • Konin, Poland, 62-510
        • Site Reference ID/Investigator# 31020
      • Krakow, Poland, 30-054
        • Site Reference ID/Investigator# 31019
      • Krakow, Poland, 30-082
        • Site Reference ID/Investigator# 31087
      • Krakow, Poland, 30-111
        • Site Reference ID/Investigator# 31050
      • Krakow, Poland, 31-153
        • Site Reference ID/Investigator# 31025
      • Krakow, Poland, 31-348
        • Site Reference ID/Investigator# 31043
      • Krakow, Poland, 31-467
        • Site Reference ID/Investigator# 31011
      • Krakow, Poland, 31-559
        • Site Reference ID/Investigator# 31061
      • Krakow, Poland
        • Site Reference ID/Investigator# 31053
      • Kurow, Poland, 24-170
        • Site Reference ID/Investigator# 31029
      • Lask, Poland, 98-100
        • Site Reference ID/Investigator# 31010
      • Lazy, Poland, 42-450
        • Site Reference ID/Investigator# 31096
      • Legnica, Poland, 59-220
        • Site Reference ID/Investigator# 31012
      • Leszno, Poland, 64-100
        • Site Reference ID/Investigator# 31040
      • Lidzbark Warminski, Poland, 11-100
        • Site Reference ID/Investigator# 31082
      • Lodz, Poland, 91-425
        • Site Reference ID/Investigator# 31086
      • Lodz, Poland, 91-502
        • Site Reference ID/Investigator# 31052
      • Lodz, Poland, 91-719
        • Site Reference ID/Investigator# 31047
      • Lodz, Poland, 93-513
        • Site Reference ID/Investigator# 31089
      • Lodz, Poland, 93-588
        • Site Reference ID/Investigator# 31060
      • Lomza, Poland, 18-400
        • Site Reference ID/Investigator# 31039
      • Lublin, Poland, 20-352
        • Site Reference ID/Investigator# 31049
      • Lublin, Poland, 20-468
        • Site Reference ID/Investigator# 31100
      • Lublin, Poland, 20-554
        • Site Reference ID/Investigator# 33278
      • Lublin, Poland, 20-718
        • Site Reference ID/Investigator# 31103
      • Lublin, Poland, 20-718
        • Site Reference ID/Investigator# 31104
      • Lublin, Poland, 20-827
        • Site Reference ID/Investigator# 30998
      • Michalowice Osiedle, Poland, 05-816
        • Site Reference ID/Investigator# 31056
      • Milcz, Poland, 56-300
        • Site Reference ID/Investigator# 31001
      • Nysa, Poland, 48-300
        • Site Reference ID/Investigator# 31085
      • Oborniki Slaskie, Poland, 55-120
        • Site Reference ID/Investigator# 30993
      • Olsztyn, Poland, 10-229
        • Site Reference ID/Investigator# 30974
      • Olsztyn, Poland, 10-950
        • Site Reference ID/Investigator# 31080
      • Opole, Poland, 45-002
        • Site Reference ID/Investigator# 30989
      • Opole, Poland, 45-007
        • Site Reference ID/Investigator# 30978
      • Opole, Poland, 45-061
        • Site Reference ID/Investigator# 30982
      • Opole, Poland, 45-367
        • Site Reference ID/Investigator# 31033
      • Opole, Poland, 45-367
        • Site Reference ID/Investigator# 31075
      • Ostrow Wielkopolski, Poland, 63-400
        • Site Reference ID/Investigator# 31042
      • Pila, Poland, 64-920
        • Site Reference ID/Investigator# 31069
      • Piotrkow Trybunalski, Poland, 97-300
        • Site Reference ID/Investigator# 31000
      • Plock, Poland, 09-409
        • Site Reference ID/Investigator# 31013
      • Poddebice, Poland, 99-200
        • Site Reference ID/Investigator# 31009
      • Poznan, Poland, 60-195
        • Site Reference ID/Investigator# 31045
      • Poznan, Poland, 60-232
        • Site Reference ID/Investigator# 31088
      • Poznan, Poland, 60-362
        • Site Reference ID/Investigator# 31021
      • Poznan, Poland, 60-409
        • Site Reference ID/Investigator# 31058
      • Poznan, Poland, 60-638
        • Site Reference ID/Investigator# 31034
      • Poznan, Poland, 60-835
        • Site Reference ID/Investigator# 30985
      • Pulawy, Poland, 24-100
        • Site Reference ID/Investigator# 31005
      • Pulawy, Poland, 24-100
        • Site Reference ID/Investigator# 31064
      • Puszczykowo, Poland, 62-041
        • Site Reference ID/Investigator# 30979
      • Pyskowice, Poland, 44-120
        • Site Reference ID/Investigator# 31022
      • Radlin, Poland, 44-310
        • Site Reference ID/Investigator# 31016
      • Radom, Poland, 26-610
        • Site Reference ID/Investigator# 31099
      • Rzeszow, Poland, 35-003
        • Site Reference ID/Investigator# 31041
      • Siedlce, Poland, 08-110
        • Site Reference ID/Investigator# 31024
      • Siemianowice Slaskie, Poland, 41-106
        • Site Reference ID/Investigator# 30988
      • Sieradz, Poland, 98-200
        • Site Reference ID/Investigator# 31063
      • Sosnowiec, Poland, 41-200
        • Site Reference ID/Investigator# 31015
      • Starachowice, Poland, 27-300
        • Site Reference ID/Investigator# 30983
      • Suwalki, Poland, 16-400
        • Site Reference ID/Investigator# 31084
      • Suwalki, Poland, 16-400
        • Site Reference ID/Investigator# 31092
      • Suwałki, Poland, 16-400
        • Site Reference ID/Investigator# 33277
      • Swarzedz, Poland, 62-020
        • Site Reference ID/Investigator# 31008
      • Swietochlowice, Poland, 41-608
        • Site Reference ID/Investigator# 31003
      • Szczecin, Poland, 70-123
        • Site Reference ID/Investigator# 30975
      • Szczecin, Poland, 71-050
        • Site Reference ID/Investigator# 31046
      • Szczecin, Poland, 71-126
        • Site Reference ID/Investigator# 30992
      • Szczecin, Poland, 71-132
        • Site Reference ID/Investigator# 31035
      • Tarnow, Poland, 33-100
        • Site Reference ID/Investigator# 31071
      • Tarnow, Poland, 33-100
        • Site Reference ID/Investigator# 31091
      • Tarnowskie Gory, Poland, 42-600
        • Site Reference ID/Investigator# 31079
      • Tomaszow Mazowiecki, Poland, 97-200
        • Site Reference ID/Investigator# 30980
      • Torun, Poland, 87-100
        • Site Reference ID/Investigator# 31059
      • Turek, Poland, 62-700
        • Site Reference ID/Investigator# 30987
      • Warsaw, Poland, 01-636
        • Site Reference ID/Investigator# 31066
      • Warsaw, Poland, 02-156
        • Site Reference ID/Investigator# 31037
      • Warsaw, Poland, 02-507
        • Site Reference ID/Investigator# 31105
      • Warsaw, Poland, 02-507
        • Site Reference ID/Investigator# 31106
      • Warsaw, Poland, 02-671
        • Site Reference ID/Investigator# 31093
      • Warsaw, Poland, 02-671
        • Site Reference ID/Investigator# 31094
      • Warsaw, Poland, 02-671
        • Site Reference ID/Investigator# 31095
      • Warsaw, Poland, 03-748
        • Site Reference ID/Investigator# 31081
      • Warsaw, Poland, 05-075
        • Site Reference ID/Investigator# 31078
      • Wieliczka, Poland, 32-020
        • Site Reference ID/Investigator# 30986
      • Wroclaw, Poland, 51-318
        • Site Reference ID/Investigator# 31027
      • Wroclaw, Poland, 51-318
        • Site Reference ID/Investigator# 31038
      • Wroclaw, Poland, 52-204
        • Site Reference ID/Investigator# 31062
      • Wroclaw, Poland, 53-008
        • Site Reference ID/Investigator# 31070
      • Wroclaw, Poland, 53-020
        • Site Reference ID/Investigator# 31077
      • Wroclaw, Poland, 53-301
        • Site Reference ID/Investigator# 31072
      • Zabrze, Poland, 41-800
        • Site Reference ID/Investigator# 31098
      • Zamosc, Poland, 22-400
        • Site Reference ID/Investigator# 30996
      • Zlotniki, Poland, 46-061
        • Site Reference ID/Investigator# 31073
      • Zory, Poland, 44-240
        • Site Reference ID/Investigator# 30981
  • Ukraine
      • Dnepropetrovsk, Ukraine, 49017
        • Site Reference ID/Investigator# 31108
      • Dnepropetrovsk, Ukraine, 49017
        • Site Reference ID/Investigator# 31109
      • Donetsk, Ukraine, 83000
        • Site Reference ID/Investigator# 31111
      • Kharkov, Ukraine, 61070
        • Site Reference ID/Investigator# 31112
      • Kharkov, Ukraine, 61070
        • Site Reference ID/Investigator# 31113
      • Kharkov, Ukraine, 61070
        • Site Reference ID/Investigator# 31114
      • Kiev, Ukraine, 01030
        • Site Reference ID/Investigator# 31209
      • Kiev, Ukraine, 03022
        • Site Reference ID/Investigator# 31110
      • Kiev, Ukraine, 04107
        • Site Reference ID/Investigator# 21103
      • Kiev, Ukraine, 04107
        • Site Reference ID/Investigator# 31107
      • Simferopol', Ukraine, 95017
        • Site Reference ID/Investigator# 31115

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Sampling Method

Non-Probability Sample

Study Population

Primary care clinic

Description

Inclusion Criteria:

  • Age > 50 years
  • Locally advanced (T3-T4) and/or metastatic (N+/M+) hormone-sensitive prostate cancer, confirmed by histological examination
  • Presence of lower urinary tract symptoms (LUTS)-IPSS >0
  • Treatment with Lucrin® Depot is the routine therapy in the patient. The decision as to Lucrin® Depot choice will not be associated with patient's participation in the study, but will result from the best medical knowledge and practice.
  • Until inclusion into PMOS the patient has not been treated with GnRH analogue.
  • The patient, before inclusion into the study, has not been treated by surgery (radical prostatectomy).

Exclusion Criteria:

  • Patients will not be included into the study if any contraindications to treatment with Lucrin® Depot exist, or if there are other treatment options which, according to the present medical knowledge, are potentially more beneficial for the patient.
  • Physician or patient can stop treatment at any moment, if any indications or reasons exist.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Adv. PCa patients with LUTS treated with GnRH analogue
Patients with advanced prostate cancer and lower urinary tract symptoms treated with GnRH analogue Lucrin Depot 11.25 mg (Lucrin Depot 3.75mg - in Ukraine)
Drug: Leuprolide acetate Depot Susp. 11.25 mg (Poland), 3.75 mg (Ukraine)
Leuprolide acetate 11.25 mg every 3 months sc or im, number of injections during the trial - 5 in Poland, Leuprolide acetate 3.75 mg every 1 month sc or im, number of injections during the trial - 12 in Ukraine.
Other Names:
  • Lupron Depot/Leuprolide acetate 11.25 mg
  • Lucrin Depot 11.25 mg
  • Lupron Depot/Leuprolide acetate 3.75 mg
  • Lucrin Depot 3.75 mg

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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.
Baseline to 12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
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.
Baseline to 3, 6, 9, and 12 months.
Percentage of Patients at Baseline With One of the Symptoms Connected With Prostate Cancer.
Time Frame: Baseline
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.
Baseline
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.
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.
Baseline to 3, 6, 9, and 12 months.
Reported Adverse Events/Serious Adverse Events
Time Frame: Baseline to 12 months
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.
Baseline to 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Abbott

Collaborators

Fraktal.com.pl
Med-net.pl

Investigators

  • Study Director: Jozef Haczynski, MD, PhD, Abbott Laboratories, Poland

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2008

Primary Completion (Actual)

November 1, 2010

Study Completion (Actual)

November 1, 2010

Study Registration Dates

First Submitted

February 28, 2010

First Submitted That Met QC Criteria

February 28, 2010

First Posted (Estimate)

March 2, 2010

Study Record Updates

Last Update Posted (Estimate)

January 16, 2012

Last Update Submitted That Met QC Criteria

January 12, 2012

Last Verified

January 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • P10-612

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Lower Urinary Tract Symptoms

Clinical Trials on Leuprolide acetate Depot Susp. 11.25 mg (Poland), 3.75 mg (Ukraine)

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Philippines

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe