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 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
Observational
Observational Model: Case-Only, Time Perspective: Prospective
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
Jozef Haczynski, MD, PhD
Study Director
Abbott Laboratories, Poland
Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
P10-612
NCT01078545
September 2008
November 2010
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