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

Lower Urinary Tract Symptoms Clinical Trial

— LEMON  

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01078545
• Other study ID #: P10-612
• Status: Completed
• Phase: N/A
• First received: February 28, 2010
• Last updated: January 12, 2012
• Start date: September 2008
• Est. completion date: November 2010

Study information

• Verified date: January 2012
• Source: Abbott
• Contact: n/a
• Is FDA regulated: No
• Health authority: Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal ProductsUkraine: Ministry of Health
• Study type: Observational

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 729
• Est. completion date: November 2010
• Est. primary completion date: November 2010
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 50 Years and older

Eligibility

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 Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Advanced Prostate Cancer
• Lower Urinary Tract Symptoms
• Prostatic Neoplasms

Intervention

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.

Locations

Country	Name	City	State
Poland	Site Reference ID/Investigator# 31076	Belchatow
Poland	Site Reference ID/Investigator# 30977	Bialystok
Poland	Site Reference ID/Investigator# 31002	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# 30976	Brwinow
Poland	Site Reference ID/Investigator# 31028	Bydgoszcz
Poland	Site Reference ID/Investigator# 31006	Bytom
Poland	Site Reference ID/Investigator# 31014	Bytom
Poland	Site Reference ID/Investigator# 31018	Bytom
Poland	Site Reference ID/Investigator# 31007	Ciechanow
Poland	Site Reference ID/Investigator# 31004	Elblag
Poland	Site Reference ID/Investigator# 31090	Elblag
Poland	Site Reference ID/Investigator# 31044	Elk
Poland	Site Reference ID/Investigator# 30994	Florentynow
Poland	Site Reference ID/Investigator# 31057	Gdansk
Poland	Site Reference ID/Investigator# 31097	Gdansk
Poland	Site Reference ID/Investigator# 31101	Gdansk
Poland	Site Reference ID/Investigator# 9803	Gdansk
Poland	Site Reference ID/Investigator# 30984	Gliwice
Poland	Site Reference ID/Investigator# 31051	Imielnik Stary
Poland	Site Reference ID/Investigator# 31023	Inowroclaw
Poland	Site Reference ID/Investigator# 31074	Inowroclaw
Poland	Site Reference ID/Investigator# 31032	Jankowo
Poland	Site Reference ID/Investigator# 31067	Jaroslawiec
Poland	Site Reference ID/Investigator# 30995	Jastkow
Poland	Site Reference ID/Investigator# 31031	Jastrzebie Zdroj
Poland	Site Reference ID/Investigator# 31065	Jastrzebie Zdroj
Poland	Site Reference ID/Investigator# 31054	Jelenia Gora
Poland	Site Reference ID/Investigator# 30997	Katowice
Poland	Site Reference ID/Investigator# 31036	Katowice
Poland	Site Reference ID/Investigator# 30999	Kielce
Poland	Site Reference ID/Investigator# 31055	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# 31011	Krakow
Poland	Site Reference ID/Investigator# 31019	Krakow
Poland	Site Reference ID/Investigator# 31025	Krakow
Poland	Site Reference ID/Investigator# 31043	Krakow
Poland	Site Reference ID/Investigator# 31050	Krakow
Poland	Site Reference ID/Investigator# 31053	Krakow
Poland	Site Reference ID/Investigator# 31061	Krakow
Poland	Site Reference ID/Investigator# 31087	Krakow
Poland	Site Reference ID/Investigator# 31029	Kurow
Poland	Site Reference ID/Investigator# 31010	Lask
Poland	Site Reference ID/Investigator# 31096	Lazy
Poland	Site Reference ID/Investigator# 31012	Legnica
Poland	Site Reference ID/Investigator# 31040	Leszno
Poland	Site Reference ID/Investigator# 31082	Lidzbark Warminski
Poland	Site Reference ID/Investigator# 31047	Lodz
Poland	Site Reference ID/Investigator# 31052	Lodz
Poland	Site Reference ID/Investigator# 31060	Lodz
Poland	Site Reference ID/Investigator# 31086	Lodz
Poland	Site Reference ID/Investigator# 31089	Lodz
Poland	Site Reference ID/Investigator# 31039	Lomza
Poland	Site Reference ID/Investigator# 30998	Lublin
Poland	Site Reference ID/Investigator# 31049	Lublin
Poland	Site Reference ID/Investigator# 31100	Lublin
Poland	Site Reference ID/Investigator# 31103	Lublin
Poland	Site Reference ID/Investigator# 31104	Lublin
Poland	Site Reference ID/Investigator# 33278	Lublin
Poland	Site Reference ID/Investigator# 31056	Michalowice Osiedle
Poland	Site Reference ID/Investigator# 31001	Milcz
Poland	Site Reference ID/Investigator# 31085	Nysa
Poland	Site Reference ID/Investigator# 30993	Oborniki Slaskie
Poland	Site Reference ID/Investigator# 30974	Olsztyn
Poland	Site Reference ID/Investigator# 31080	Olsztyn
Poland	Site Reference ID/Investigator# 30978	Opole
Poland	Site Reference ID/Investigator# 30982	Opole
Poland	Site Reference ID/Investigator# 30989	Opole
Poland	Site Reference ID/Investigator# 31033	Opole
Poland	Site Reference ID/Investigator# 31075	Opole
Poland	Site Reference ID/Investigator# 31042	Ostrow Wielkopolski
Poland	Site Reference ID/Investigator# 31069	Pila
Poland	Site Reference ID/Investigator# 31000	Piotrkow Trybunalski
Poland	Site Reference ID/Investigator# 31013	Plock
Poland	Site Reference ID/Investigator# 31009	Poddebice
Poland	Site Reference ID/Investigator# 30985	Poznan
Poland	Site Reference ID/Investigator# 31021	Poznan
Poland	Site Reference ID/Investigator# 31034	Poznan
Poland	Site Reference ID/Investigator# 31045	Poznan
Poland	Site Reference ID/Investigator# 31058	Poznan
Poland	Site Reference ID/Investigator# 31088	Poznan
Poland	Site Reference ID/Investigator# 31005	Pulawy
Poland	Site Reference ID/Investigator# 31064	Pulawy
Poland	Site Reference ID/Investigator# 30979	Puszczykowo
Poland	Site Reference ID/Investigator# 31022	Pyskowice
Poland	Site Reference ID/Investigator# 31016	Radlin
Poland	Site Reference ID/Investigator# 31099	Radom
Poland	Site Reference ID/Investigator# 31041	Rzeszow
Poland	Site Reference ID/Investigator# 31024	Siedlce
Poland	Site Reference ID/Investigator# 30988	Siemianowice Slaskie
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	Suwalki
Poland	Site Reference ID/Investigator# 31092	Suwalki
Poland	Site Reference ID/Investigator# 33277	Suwalki
Poland	Site Reference ID/Investigator# 31008	Swarzedz
Poland	Site Reference ID/Investigator# 31003	Swietochlowice
Poland	Site Reference ID/Investigator# 30975	Szczecin
Poland	Site Reference ID/Investigator# 30992	Szczecin
Poland	Site Reference ID/Investigator# 31035	Szczecin
Poland	Site Reference ID/Investigator# 31046	Szczecin
Poland	Site Reference ID/Investigator# 31071	Tarnow
Poland	Site Reference ID/Investigator# 31091	Tarnow
Poland	Site Reference ID/Investigator# 31079	Tarnowskie Gory
Poland	Site Reference ID/Investigator# 30980	Tomaszow Mazowiecki
Poland	Site Reference ID/Investigator# 31059	Torun
Poland	Site Reference ID/Investigator# 30987	Turek
Poland	Site Reference ID/Investigator# 31037	Warsaw
Poland	Site Reference ID/Investigator# 31066	Warsaw
Poland	Site Reference ID/Investigator# 31078	Warsaw
Poland	Site Reference ID/Investigator# 31081	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# 31105	Warsaw
Poland	Site Reference ID/Investigator# 31106	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# 31072	Wroclaw
Poland	Site Reference ID/Investigator# 31077	Wroclaw
Poland	Site Reference ID/Investigator# 31098	Zabrze
Poland	Site Reference ID/Investigator# 30996	Zamosc
Poland	Site Reference ID/Investigator# 31073	Zlotniki
Poland	Site Reference ID/Investigator# 30981	Zory
Ukraine	Site Reference ID/Investigator# 31108	Dnepropetrovsk
Ukraine	Site Reference ID/Investigator# 31109	Dnepropetrovsk
Ukraine	Site Reference ID/Investigator# 31111	Donetsk
Ukraine	Site Reference ID/Investigator# 31112	Kharkov
Ukraine	Site Reference ID/Investigator# 31113	Kharkov
Ukraine	Site Reference ID/Investigator# 31114	Kharkov
Ukraine	Site Reference ID/Investigator# 21103	Kiev
Ukraine	Site Reference ID/Investigator# 31107	Kiev
Ukraine	Site Reference ID/Investigator# 31110	Kiev
Ukraine	Site Reference ID/Investigator# 31209	Kiev
Ukraine	Site Reference ID/Investigator# 31115	Simferopol'

Sponsors (3)

Lead Sponsor	Collaborator
Abbott	Fraktal.com.pl, Med-net.pl

Countries where clinical trial is conducted

Poland,  Ukraine, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The Change in the International Prostate Symptom Score (IPSS) From Baseline to Month 12. The IPSS Has a Range From 0 to 35.	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	No
Secondary	The Change in the International Prostate Symptom Score (IPSS) From 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.	No
Secondary	Percentage of Patients at Baseline With One of the Symptoms Connected With Prostate Cancer.	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	No
Secondary	Changes in the Intensity of Symptoms Connected With Prostate Cancer From Baseline to Month 3, 6, 9, and 12.	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.	No
Secondary	Reported Adverse Events/Serious Adverse Events	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	Yes