Lower Urinary Tract Symptoms Clinical Trial
— LEMONOfficial 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.
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.
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. |
Observational Model: Case-Only, Time Perspective: Prospective
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' |
Lead Sponsor | Collaborator |
---|---|
Abbott | Fraktal.com.pl, Med-net.pl |
Poland, Ukraine,
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 |
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