A Selective Androgen Receptor Modulator for Symptom Management in Prostate Cancer
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 114
- 试验地点
- 4
- 主要终点
- Change in Sexual Activity Score of Psychosexual Daily Questionnaire (PDQ-4)
研究概览
简要总结
This research study is studying the use of a targeted therapy called LY SARM, which is an investigational drug from a new class of molecules called Selective Androgen Receptor Modulators (SARMs) as a possible improvement in quality of life for participants who have undergone radical prostatectomy. Androgens are a group of hormones that play a role in male traits and reproductive activity.
The names of the study interventions involved in this study are:
- LY2452473
详细描述
This research study is a Phase II clinical trial. Phase II clinical trials test the safety and effectiveness of an investigational intervention to learn whether the intervention works in treating a specific disease. "Investigational" means that the intervention is being studied.
The FDA (the U.S. Food and Drug Administration) has not approved LY SARM/LY2452473 as a treatment for any disease.
In this research study, the investigators are studying a new investigational drug called LY SARM (LY2452473). Concerns about the potential adverse effects of testosterone on the prostate have led to the development of molecules called SARMs (Selective Androgen Receptor Modulators). This investigational drug may improve sexual function, quality of life, muscle and bone mass in men with prostate cancer. This molecule was chosen because there is some evidence that shows it may help to improve sexual function and aid in the improvement of muscle mass while not having any influence on the prostate.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Placebo
Subjects who meet the eligibility criteria, will be randomized, to either placebo, LY SARM Dose 1, LY SARM Dose 2 or LY SARM Dose 3 daily, oral per cycle.
干预措施: Placebo (Drug)
LY2452473 Dose 1
Subjects who meet the eligibility criteria, will be randomized, to either placebo, LY SARM Dose 1, LY SARM Dose 2 or LY SARM Dose 3 daily, oral per cycle.
干预措施: LY2452473 (Drug)
LY2452473 Dose 2
Subjects who meet the eligibility criteria, will be randomized, to either placebo, LY SARM Dose 1 or LY SARM Dose 2 or LY SARM Dose 3 daily, oral per cycle.
干预措施: LY2452473 (Drug)
LY2452473 Dose 3
Subjects who meet the eligibility criteria, will be randomized, to either placebo, LY SARM Dose 1, LY SARM Dose 2 or LY SARM Dose 3 daily, oral per cycle.
干预措施: LY2452473 (Drug)
结局指标
主要结局
Change in Sexual Activity Score of Psychosexual Daily Questionnaire (PDQ-4)
时间窗: 12 weeks from baseline
The primary outcome is change in sexual activity score, assessed by the Psychosexual Daily Questionnaire (PDQ). The questionnaire covered 3 different domains: 1) sexual desire, enjoyment, and performance; 2) sexual activity score; and 3) mood. Sexual activity was assessed using a checklist format (12-item) and the score range of 0 to 12 with higher scores representing better sexual activity.
次要结局
- Change in All Domains of International Index of Erectile Function (IIEF)(12 weeks from baseline)
- Change in Derogatis Index of Sexual Function Male II (DISF-M-II)(12 weeks from baseline)
- Change in Serum Sex Hormone-binding Globulin (SHBG) Level(12 weeks from baseline)
- Change in Serum Luteinizing Hormone (LH) Level(12 weeks from baseline)
- Change in Estradiol Levels(12 weeks from baseline)
- Change of White Blood Cell(12 weeks from baseline)
- Change of Red Blood Cell(12 weeks from baseline)
- Change in Hematocrit(12 weeks from baseline)
- Change in Sexual Activity, Interest, and Desire Scale (SAID)(12 weeks from baseline)
- Change in Three Domains of Men's Sexual Health Questionnaire (MSHQ)(12 weeks from baseline)
- Change in Two Domains of Expanded Prostate Cancer Index Composite (EPIC)(12 weeks from baseline)
- Change in Functional Assessment of Chronic Illness Therapy (FACIT) Fatigue Scale(12 weeks from baseline)
- Change in Hypogonadism Energy Diary (HED)(12 weeks from baseline)
- Change in International Prostate Symptom Score (IPSS)(12 weeks from baseline)
- Change in Positive and Negative Affect Scale (PANAS)(12 weeks from baseline)
- Change in Body Mass Using DXA(12 weeks from baseline)
- Change of Maximal Voluntary Muscle Strength(12 weeks from baseline)
- Change in Gait Speed in 6-minute Walk(12 weeks from baseline)
- Change of 50 Meters Walk Tests- Unloaded /Loaded(12 weeks from baseline)
- Change in Power of Stair Climbing Tests- Unloaded/Loaded(12 weeks from baseline)
- Change in Serum Total Testosterone Level(12 weeks from baseline)
- Change in Free Testosterone Level(12 weeks from baseline)
- Change of Mean Corpuscular Volume (MCV)(12 weeks from baseline)
- Change in Hemoglobin(12 weeks from baseline)
- Change of Red Blood Cell Distribution Width (RDW)(12 weeks from baseline)
- Change in Platelet Count(12 weeks from baseline)
- Change of Aspartate Aminotransferase (AST)(12 weeks from baseline)
- Change of Alanine Aminotransferase (ALT)(12 weeks from baseline)
- Change of Total Bilirubin(12 weeks from baseline)
- Change in Serum Alkaline Phosphatase(12 weeks from baseline)
- Change of Lipid Panel(12 weeks from baseline)
- Change in Fasting Glucose Levels(12 weeks from baseline)
- Change in Insulin(12 weeks from baseline)
研究者
Shalender Bhasin, MD
Principal Investigator
Dana-Farber Cancer Institute