Lucrin® Depot Efficacy and Safety Monitoring Study in Patients With Advanced Prostate Cancer and Lower Urinary Tract Symptoms (LUTS)
NCT ID: NCT01078545
Last Updated: 2012-01-16
Study Results
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View full resultsBasic Information
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COMPLETED
729 participants
OBSERVATIONAL
2008-09-30
2010-11-30
Brief Summary
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Detailed Description
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\- to assess the intensity of LUTS in Polish and Ukrainian patients with locally advanced and metastatic prostate cancer, previously untreated with hormonal therapy
Conditions
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Study Design
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CASE_ONLY
PROSPECTIVE
Study Groups
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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)
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.
Interventions
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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 Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* Physician or patient can stop treatment at any moment, if any indications or reasons exist.
50 Years
MALE
No
Sponsors
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Fraktal.com.pl
UNKNOWN
Med-net.pl
UNKNOWN
Abbott
INDUSTRY
Responsible Party
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Principal Investigators
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Jozef Haczynski, MD, PhD
Role: STUDY_DIRECTOR
Abbott Laboratories, Poland
Locations
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Site Reference ID/Investigator# 31076
Bełchatów, , Poland
Site Reference ID/Investigator# 31002
Bialystok, , Poland
Site Reference ID/Investigator# 30977
Bialystok, , Poland
Site Reference ID/Investigator# 31030
Bialystok, , Poland
Site Reference ID/Investigator# 31048
Bialystok, , Poland
Site Reference ID/Investigator# 31083
Bobrowniki, , Poland
Site Reference ID/Investigator# 31028
Bydgoszcz, , Poland
Site Reference ID/Investigator# 31014
Bytom, , Poland
Site Reference ID/Investigator# 31006
Bytom, , Poland
Site Reference ID/Investigator# 31018
Bytom, , Poland
Site Reference ID/Investigator# 31007
Ciechanów, , Poland
Site Reference ID/Investigator# 31004
Elblag, , Poland
Site Reference ID/Investigator# 31090
Elblag, , Poland
Site Reference ID/Investigator# 31044
Ełk, , Poland
Site Reference ID/Investigator# 30994
Florentynów, , Poland
Site Reference ID/Investigator# 9803
Gdansk, , Poland
Site Reference ID/Investigator# 31057
Gdansk, , Poland
Site Reference ID/Investigator# 31101
Gdansk, , Poland
Site Reference ID/Investigator# 31097
Gdansk, , Poland
Site Reference ID/Investigator# 30984
Gliwice, , Poland
Site Reference ID/Investigator# 30976
Gmina Brwinów, , Poland
Site Reference ID/Investigator# 31009
Gmina Poddębice, , Poland
Site Reference ID/Investigator# 31051
Imielnik Stary, , Poland
Site Reference ID/Investigator# 31023
Inowrocław, , Poland
Site Reference ID/Investigator# 31074
Inowrocław, , Poland
Site Reference ID/Investigator# 31032
Jankowo, , Poland
Site Reference ID/Investigator# 31067
Jarosławiec, , Poland
Site Reference ID/Investigator# 30995
Jastków, , Poland
Site Reference ID/Investigator# 31065
Jastrzębie Zdrój, , Poland
Site Reference ID/Investigator# 31031
Jastrzębie Zdrój, , Poland
Site Reference ID/Investigator# 31054
Jelenia Góra, , Poland
Site Reference ID/Investigator# 30997
Katowice, , Poland
Site Reference ID/Investigator# 31036
Katowice, , Poland
Site Reference ID/Investigator# 31055
Kielce, , Poland
Site Reference ID/Investigator# 30999
Kielce, , Poland
Site Reference ID/Investigator# 31102
Kluczbork, , Poland
Site Reference ID/Investigator# 31068
Kolbudy, , Poland
Site Reference ID/Investigator# 31020
Konin, , Poland
Site Reference ID/Investigator# 31019
Krakow, , Poland
Site Reference ID/Investigator# 31087
Krakow, , Poland
Site Reference ID/Investigator# 31050
Krakow, , Poland
Site Reference ID/Investigator# 31025
Krakow, , Poland
Site Reference ID/Investigator# 31043
Krakow, , Poland
Site Reference ID/Investigator# 31011
Krakow, , Poland
Site Reference ID/Investigator# 31061
Krakow, , Poland
Site Reference ID/Investigator# 31053
Krakow, , Poland
Site Reference ID/Investigator# 31029
Kurów, , Poland
Site Reference ID/Investigator# 31012
Legnica, , Poland
Site Reference ID/Investigator# 31040
Leszno, , Poland
Site Reference ID/Investigator# 31082
Lidzbark Warmiński, , Poland
Site Reference ID/Investigator# 31086
Lodz, , Poland
Site Reference ID/Investigator# 31052
Lodz, , Poland
Site Reference ID/Investigator# 31047
Lodz, , Poland
Site Reference ID/Investigator# 31089
Lodz, , Poland
Site Reference ID/Investigator# 31060
Lodz, , Poland
Site Reference ID/Investigator# 31049
Lublin, , Poland
Site Reference ID/Investigator# 31100
Lublin, , Poland
Site Reference ID/Investigator# 33278
Lublin, , Poland
Site Reference ID/Investigator# 31103
Lublin, , Poland
Site Reference ID/Investigator# 31104
Lublin, , Poland
Site Reference ID/Investigator# 30998
Lublin, , Poland
Site Reference ID/Investigator# 31056
Michałowice, , Poland
Site Reference ID/Investigator# 31001
Milcz, , Poland
Site Reference ID/Investigator# 31085
Nysa, , Poland
Site Reference ID/Investigator# 30993
Oborniki Śląskie, , Poland
Site Reference ID/Investigator# 30974
Olsztyn, , Poland
Site Reference ID/Investigator# 31080
Olsztyn, , Poland
Site Reference ID/Investigator# 30989
Opole, , Poland
Site Reference ID/Investigator# 30978
Opole, , Poland
Site Reference ID/Investigator# 30982
Opole, , Poland
Site Reference ID/Investigator# 31033
Opole, , Poland
Site Reference ID/Investigator# 31075
Opole, , Poland
Site Reference ID/Investigator# 31042
Ostrów Wielkopolski, , Poland
Site Reference ID/Investigator# 31000
Piotrkow Trybunalski, , Poland
Site Reference ID/Investigator# 31069
Piła, , Poland
Site Reference ID/Investigator# 31045
Poznan, , Poland
Site Reference ID/Investigator# 31088
Poznan, , Poland
Site Reference ID/Investigator# 31021
Poznan, , Poland
Site Reference ID/Investigator# 31058
Poznan, , Poland
Site Reference ID/Investigator# 31034
Poznan, , Poland
Site Reference ID/Investigator# 30985
Poznan, , Poland
Site Reference ID/Investigator# 30979
Puszczykowo, , Poland
Site Reference ID/Investigator# 31005
Puławy, , Poland
Site Reference ID/Investigator# 31064
Puławy, , Poland
Site Reference ID/Investigator# 31022
Pyskowice, , Poland
Site Reference ID/Investigator# 31013
Płock, , Poland
Site Reference ID/Investigator# 31016
Radlin, , Poland
Site Reference ID/Investigator# 31099
Radom, , Poland
Site Reference ID/Investigator# 31041
Rzeszów, , Poland
Site Reference ID/Investigator# 31024
Siedlce, , Poland
Site Reference ID/Investigator# 30988
Siemianowice Śląskie, , Poland
Site Reference ID/Investigator# 31063
Sieradz, , Poland
Site Reference ID/Investigator# 31015
Sosnowiec, , Poland
Site Reference ID/Investigator# 30983
Starachowice, , Poland
Site Reference ID/Investigator# 31084
Suwałki, , Poland
Site Reference ID/Investigator# 31092
Suwałki, , Poland
Site Reference ID/Investigator# 33277
Suwałki, , Poland
Site Reference ID/Investigator# 31008
Swarzędz, , Poland
Site Reference ID/Investigator# 30975
Szczecin, , Poland
Site Reference ID/Investigator# 31046
Szczecin, , Poland
Site Reference ID/Investigator# 30992
Szczecin, , Poland
Site Reference ID/Investigator# 31035
Szczecin, , Poland
Site Reference ID/Investigator# 31003
Świętochłowice, , Poland
Site Reference ID/Investigator# 31079
Tarnowskie Góry, , Poland
Site Reference ID/Investigator# 31071
Tarnów, , Poland
Site Reference ID/Investigator# 31091
Tarnów, , Poland
Site Reference ID/Investigator# 30980
Tomaszów Mazowiecki, , Poland
Site Reference ID/Investigator# 31059
Torun, , Poland
Site Reference ID/Investigator# 30987
Turek, , Poland
Site Reference ID/Investigator# 31066
Warsaw, , Poland
Site Reference ID/Investigator# 31037
Warsaw, , Poland
Site Reference ID/Investigator# 31105
Warsaw, , Poland
Site Reference ID/Investigator# 31106
Warsaw, , Poland
Site Reference ID/Investigator# 31093
Warsaw, , Poland
Site Reference ID/Investigator# 31094
Warsaw, , Poland
Site Reference ID/Investigator# 31095
Warsaw, , Poland
Site Reference ID/Investigator# 31081
Warsaw, , Poland
Site Reference ID/Investigator# 31078
Warsaw, , Poland
Site Reference ID/Investigator# 30986
Wieliczka, , Poland
Site Reference ID/Investigator# 31027
Wroclaw, , Poland
Site Reference ID/Investigator# 31038
Wroclaw, , Poland
Site Reference ID/Investigator# 31062
Wroclaw, , Poland
Site Reference ID/Investigator# 31070
Wroclaw, , Poland
Site Reference ID/Investigator# 31077
Wroclaw, , Poland
Site Reference ID/Investigator# 31072
Wroclaw, , Poland
Site Reference ID/Investigator# 31098
Zabrze, , Poland
Site Reference ID/Investigator# 30996
Zamość, , Poland
Site Reference ID/Investigator# 31073
Złotniki, , Poland
Site Reference ID/Investigator# 30981
Żory, , Poland
Site Reference ID/Investigator# 31010
Łask, , Poland
Site Reference ID/Investigator# 31096
Łazy, , Poland
Site Reference ID/Investigator# 31039
Łomża, , Poland
Site Reference ID/Investigator# 31108
Dnipro, , Ukraine
Site Reference ID/Investigator# 31109
Dnipro, , Ukraine
Site Reference ID/Investigator# 31111
Donetsk, , Ukraine
Site Reference ID/Investigator# 31112
Kharkiv, , Ukraine
Site Reference ID/Investigator# 31113
Kharkiv, , Ukraine
Site Reference ID/Investigator# 31114
Kharkiv, , Ukraine
Site Reference ID/Investigator# 31209
Kiev, , Ukraine
Site Reference ID/Investigator# 31110
Kiev, , Ukraine
Site Reference ID/Investigator# 21103
Kiev, , Ukraine
Site Reference ID/Investigator# 31107
Kiev, , Ukraine
Site Reference ID/Investigator# 31115
Simferopol, , Ukraine
Countries
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Other Identifiers
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P10-612
Identifier Type: -
Identifier Source: org_study_id
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