Clinical trial NCT01078545: Lucrin® Depot Efficacy and Safety Monitoring Study in Patients With Advanced Prostate Cancer and Lower Urinary Tract Symptoms (LUTS)
Official title: Lucrin® Depot Efficacy and Safety Monitoring Study in Patients With Advanced Prostate Cancer and Lower Urinary Tract Symptoms. International, Multicenter Post-marketing Observational Study.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Advanced Prostate Cancer
Lower Urinary Tract Symptoms
Keywords: Prostate cancer
Lower urinary tract symptoms
Hormonotherapy
LHRH analogue
Androgen deprivation therapy (ADT)
Lead sponsor: Abbott
Sponsor class: INDUSTRY
Collaborators: name: Fraktal.com.pl
name: Med-net.pl
First posted: 2010-03-02
Enrollment: 729
Sex: MALE
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Primary care clinic

Brief summary: 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.

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

Eligibility criteria: 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.

Primary outcomes:
measure: The Change in the International Prostate Symptom Score (IPSS) From Baseline to Month 12. The IPSS Has a Range From 0 to 35.
timeFrame: Baseline to 12 months
Secondary outcomes:
measure: The Change in the International Prostate Symptom Score (IPSS) From Baseline to 3, 6, 9, and 12 Months.
timeFrame: Baseline to 3, 6, 9, and 12 months.
measure: Percentage of Patients at Baseline With One of the Symptoms Connected With Prostate Cancer.
timeFrame: Baseline
measure: Changes in the Intensity of Symptoms Connected With Prostate Cancer From Baseline to Month 3, 6, 9, and 12.
timeFrame: Baseline to 3, 6, 9, and 12 months.
measure: Reported Adverse Events/Serious Adverse Events
timeFrame: Baseline to 12 months
Other outcomes:
Locations:
city: Belchatow
country: Poland
facility: Site Reference ID/Investigator# 31076
city: Bialystok
country: Poland
facility: Site Reference ID/Investigator# 31002
city: Bialystok
country: Poland
facility: Site Reference ID/Investigator# 30977
city: Bialystok
country: Poland
facility: Site Reference ID/Investigator# 31030
city: Bialystok
country: Poland
facility: Site Reference ID/Investigator# 31048
city: Bobrowniki
country: Poland
facility: Site Reference ID/Investigator# 31083
city: Brwinow
country: Poland
facility: Site Reference ID/Investigator# 30976
city: Bydgoszcz
country: Poland
facility: Site Reference ID/Investigator# 31028
city: Bytom
country: Poland
facility: Site Reference ID/Investigator# 31014
city: Bytom
country: Poland
facility: Site Reference ID/Investigator# 31006
city: Bytom
country: Poland
facility: Site Reference ID/Investigator# 31018
city: Ciechanow
country: Poland
facility: Site Reference ID/Investigator# 31007
city: Elblag
country: Poland
facility: Site Reference ID/Investigator# 31004
city: Elblag
country: Poland
facility: Site Reference ID/Investigator# 31090
city: Elk
country: Poland
facility: Site Reference ID/Investigator# 31044
city: Florentynow
country: Poland
facility: Site Reference ID/Investigator# 30994
city: Gdansk
country: Poland
facility: Site Reference ID/Investigator# 9803
city: Gdansk
country: Poland
facility: Site Reference ID/Investigator# 31057
city: Gdansk
country: Poland
facility: Site Reference ID/Investigator# 31101
city: Gdansk
country: Poland
facility: Site Reference ID/Investigator# 31097
city: Gliwice
country: Poland
facility: Site Reference ID/Investigator# 30984
city: Imielnik Stary
country: Poland
facility: Site Reference ID/Investigator# 31051
city: Inowroclaw
country: Poland
facility: Site Reference ID/Investigator# 31023
city: Inowroclaw
country: Poland
facility: Site Reference ID/Investigator# 31074
city: Jankowo
country: Poland
facility: Site Reference ID/Investigator# 31032
city: Jaroslawiec
country: Poland
facility: Site Reference ID/Investigator# 31067
city: Jastkow
country: Poland
facility: Site Reference ID/Investigator# 30995
city: Jastrzebie Zdroj
country: Poland
facility: Site Reference ID/Investigator# 31065
city: Jastrzebie Zdroj
country: Poland
facility: Site Reference ID/Investigator# 31031
city: Jelenia Gora
country: Poland
facility: Site Reference ID/Investigator# 31054
city: Katowice
country: Poland
facility: Site Reference ID/Investigator# 30997
city: Katowice
country: Poland
facility: Site Reference ID/Investigator# 31036
city: Kielce
country: Poland
facility: Site Reference ID/Investigator# 31055
city: Kielce
country: Poland
facility: Site Reference ID/Investigator# 30999
city: Kluczbork
country: Poland
facility: Site Reference ID/Investigator# 31102
city: Kolbudy
country: Poland
facility: Site Reference ID/Investigator# 31068
city: Konin
country: Poland
facility: Site Reference ID/Investigator# 31020
city: Krakow
country: Poland
facility: Site Reference ID/Investigator# 31019
city: Krakow
country: Poland
facility: Site Reference ID/Investigator# 31087
city: Krakow
country: Poland
facility: Site Reference ID/Investigator# 31050
city: Krakow
country: Poland
facility: Site Reference ID/Investigator# 31025
city: Krakow
country: Poland
facility: Site Reference ID/Investigator# 31043
city: Krakow
country: Poland
facility: Site Reference ID/Investigator# 31011
city: Krakow
country: Poland
facility: Site Reference ID/Investigator# 31061
city: Krakow
country: Poland
facility: Site Reference ID/Investigator# 31053
city: Kurow
country: Poland
facility: Site Reference ID/Investigator# 31029
city: Lask
country: Poland
facility: Site Reference ID/Investigator# 31010
city: Lazy
country: Poland
facility: Site Reference ID/Investigator# 31096
city: Legnica
country: Poland
facility: Site Reference ID/Investigator# 31012
city: Leszno
country: Poland
facility: Site Reference ID/Investigator# 31040
city: Lidzbark Warminski
country: Poland
facility: Site Reference ID/Investigator# 31082
city: Lodz
country: Poland
facility: Site Reference ID/Investigator# 31086
city: Lodz
country: Poland
facility: Site Reference ID/Investigator# 31052
city: Lodz
country: Poland
facility: Site Reference ID/Investigator# 31047
city: Lodz
country: Poland
facility: Site Reference ID/Investigator# 31089
city: Lodz
country: Poland
facility: Site Reference ID/Investigator# 31060
city: Lomza
country: Poland
facility: Site Reference ID/Investigator# 31039
city: Lublin
country: Poland
facility: Site Reference ID/Investigator# 31049
city: Lublin
country: Poland
facility: Site Reference ID/Investigator# 31100
city: Lublin
country: Poland
facility: Site Reference ID/Investigator# 33278
city: Lublin
country: Poland
facility: Site Reference ID/Investigator# 31103
city: Lublin
country: Poland
facility: Site Reference ID/Investigator# 31104
city: Lublin
country: Poland
facility: Site Reference ID/Investigator# 30998
city: Michalowice Osiedle
country: Poland
facility: Site Reference ID/Investigator# 31056
city: Milcz
country: Poland
facility: Site Reference ID/Investigator# 31001
city: Nysa
country: Poland
facility: Site Reference ID/Investigator# 31085
city: Oborniki Slaskie
country: Poland
facility: Site Reference ID/Investigator# 30993
city: Olsztyn
country: Poland
facility: Site Reference ID/Investigator# 30974
city: Olsztyn
country: Poland
facility: Site Reference ID/Investigator# 31080
city: Opole
country: Poland
facility: Site Reference ID/Investigator# 30989
city: Opole
country: Poland
facility: Site Reference ID/Investigator# 30978
city: Opole
country: Poland
facility: Site Reference ID/Investigator# 30982
city: Opole
country: Poland
facility: Site Reference ID/Investigator# 31033
city: Opole
country: Poland
facility: Site Reference ID/Investigator# 31075
city: Ostrow Wielkopolski
country: Poland
facility: Site Reference ID/Investigator# 31042
city: Pila
country: Poland
facility: Site Reference ID/Investigator# 31069
city: Piotrkow Trybunalski
country: Poland
facility: Site Reference ID/Investigator# 31000
city: Plock
country: Poland
facility: Site Reference ID/Investigator# 31013
city: Poddebice
country: Poland
facility: Site Reference ID/Investigator# 31009
city: Poznan
country: Poland
facility: Site Reference ID/Investigator# 31045
city: Poznan
country: Poland
facility: Site Reference ID/Investigator# 31088
city: Poznan
country: Poland
facility: Site Reference ID/Investigator# 31021
city: Poznan
country: Poland
facility: Site Reference ID/Investigator# 31058
city: Poznan
country: Poland
facility: Site Reference ID/Investigator# 31034
city: Poznan
country: Poland
facility: Site Reference ID/Investigator# 30985
city: Pulawy
country: Poland
facility: Site Reference ID/Investigator# 31005
city: Pulawy
country: Poland
facility: Site Reference ID/Investigator# 31064
city: Puszczykowo
country: Poland
facility: Site Reference ID/Investigator# 30979
city: Pyskowice
country: Poland
facility: Site Reference ID/Investigator# 31022
city: Radlin
country: Poland
facility: Site Reference ID/Investigator# 31016
city: Radom
country: Poland
facility: Site Reference ID/Investigator# 31099
city: Rzeszow
country: Poland
facility: Site Reference ID/Investigator# 31041
city: Siedlce
country: Poland
facility: Site Reference ID/Investigator# 31024
city: Siemianowice Slaskie
country: Poland
facility: Site Reference ID/Investigator# 30988
city: Sieradz
country: Poland
facility: Site Reference ID/Investigator# 31063
city: Sosnowiec
country: Poland
facility: Site Reference ID/Investigator# 31015
city: Starachowice
country: Poland
facility: Site Reference ID/Investigator# 30983
city: Suwalki
country: Poland
facility: Site Reference ID/Investigator# 31084
city: Suwalki
country: Poland
facility: Site Reference ID/Investigator# 31092
city: Suwałki
country: Poland
facility: Site Reference ID/Investigator# 33277
city: Swarzedz
country: Poland
facility: Site Reference ID/Investigator# 31008
city: Swietochlowice
country: Poland
facility: Site Reference ID/Investigator# 31003
city: Szczecin
country: Poland
facility: Site Reference ID/Investigator# 30975
city: Szczecin
country: Poland
facility: Site Reference ID/Investigator# 31046
city: Szczecin
country: Poland
facility: Site Reference ID/Investigator# 30992
city: Szczecin
country: Poland
facility: Site Reference ID/Investigator# 31035
city: Tarnowskie Gory
country: Poland
facility: Site Reference ID/Investigator# 31079
city: Tarnow
country: Poland
facility: Site Reference ID/Investigator# 31071
city: Tarnow
country: Poland
facility: Site Reference ID/Investigator# 31091
city: Tomaszow Mazowiecki
country: Poland
facility: Site Reference ID/Investigator# 30980
city: Torun
country: Poland
facility: Site Reference ID/Investigator# 31059
city: Turek
country: Poland
facility: Site Reference ID/Investigator# 30987
city: Warsaw
country: Poland
facility: Site Reference ID/Investigator# 31066
city: Warsaw
country: Poland
facility: Site Reference ID/Investigator# 31037
city: Warsaw
country: Poland
facility: Site Reference ID/Investigator# 31105
city: Warsaw
country: Poland
facility: Site Reference ID/Investigator# 31106
city: Warsaw
country: Poland
facility: Site Reference ID/Investigator# 31093
city: Warsaw
country: Poland
facility: Site Reference ID/Investigator# 31094
city: Warsaw
country: Poland
facility: Site Reference ID/Investigator# 31095
city: Warsaw
country: Poland
facility: Site Reference ID/Investigator# 31081
city: Warsaw
country: Poland
facility: Site Reference ID/Investigator# 31078
city: Wieliczka
country: Poland
facility: Site Reference ID/Investigator# 30986
city: Wroclaw
country: Poland
facility: Site Reference ID/Investigator# 31027
city: Wroclaw
country: Poland
facility: Site Reference ID/Investigator# 31038
city: Wroclaw
country: Poland
facility: Site Reference ID/Investigator# 31062
city: Wroclaw
country: Poland
facility: Site Reference ID/Investigator# 31070
city: Wroclaw
country: Poland
facility: Site Reference ID/Investigator# 31077
city: Wroclaw
country: Poland
facility: Site Reference ID/Investigator# 31072
city: Zabrze
country: Poland
facility: Site Reference ID/Investigator# 31098
city: Zamosc
country: Poland
facility: Site Reference ID/Investigator# 30996
city: Zlotniki
country: Poland
facility: Site Reference ID/Investigator# 31073
city: Zory
country: Poland
facility: Site Reference ID/Investigator# 30981
city: Dnepropetrovsk
country: Ukraine
facility: Site Reference ID/Investigator# 31108
city: Dnepropetrovsk
country: Ukraine
facility: Site Reference ID/Investigator# 31109
city: Donetsk
country: Ukraine
facility: Site Reference ID/Investigator# 31111
city: Kharkov
country: Ukraine
facility: Site Reference ID/Investigator# 31112
city: Kharkov
country: Ukraine
facility: Site Reference ID/Investigator# 31113
city: Kharkov
country: Ukraine
facility: Site Reference ID/Investigator# 31114
city: Kiev
country: Ukraine
facility: Site Reference ID/Investigator# 31209
city: Kiev
country: Ukraine
facility: Site Reference ID/Investigator# 31110
city: Kiev
country: Ukraine
facility: Site Reference ID/Investigator# 21103
city: Kiev
country: Ukraine
facility: Site Reference ID/Investigator# 31107
city: Simferopol'
country: Ukraine
facility: Site Reference ID/Investigator# 31115
Study officials:
affiliation: Abbott Laboratories, Poland
name: Jozef Haczynski, MD, PhD
role: STUDY_DIRECTOR
References: