Lucrin® Depot Efficacy and Safety Monitoring Study in Patients With Advanced Prostate Cancer and Lower Urinary Tract Symptoms. International, Multicenter Post-marketing Observational Study.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Abbott
- 入组人数
- 729
- 试验地点
- 143
- 主要终点
- The Change in the International Prostate Symptom Score (IPSS) From Baseline to Month 12. The IPSS Has a Range From 0 to 35.
研究概览
简要总结
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.
详细描述
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
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •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).
排除标准
- •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.
研究组 & 干预措施
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)
干预措施: Leuprolide acetate Depot Susp. 11.25 mg (Poland), 3.75 mg (Ukraine) (Drug)
结局指标
主要结局
The Change in the International Prostate Symptom Score (IPSS) From Baseline to Month 12. The IPSS Has a Range From 0 to 35.
时间窗: Baseline to 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.
次要结局
- The Change in the International Prostate Symptom Score (IPSS) From Baseline to 3, 6, 9, and 12 Months.(Baseline to 3, 6, 9, and 12 months.)
- Percentage of Patients at Baseline With One of the Symptoms Connected With Prostate Cancer.(Baseline)
- Reported Adverse Events/Serious Adverse Events(Baseline to 12 months)
- Changes in the Intensity of Symptoms Connected With Prostate Cancer From Baseline to Month 3, 6, 9, and 12.(Baseline to 3, 6, 9, and 12 months.)