Prospective Observation Study of Insulin Sensitivity During and After Gonadotropin Releasing Hormone (GnRH) Agonist Therapy for Prostate Cancer
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 36
- 试验地点
- 1
研究概览
简要总结
The purpose of this research study is to find out if a certain type of hormone therapy, gonadotropin-releasing hormone agonist (GnRH agonist), affects the way the body produces and responds to insulin. The investigators will evaluate the changes in insulin sensitivity during and after GnRH agonist treatment for prostate cancer. The investigators are assessing the possibility that treatment-related insulin resistance may contribute to the risk of diabetes and/or cardiovascular disease in men with prostate cancer.
详细描述
- The study will be divided into 2 groups: one group (Cohort A) will consist of men undergoing GnRH agonist therapy for at least 24 months. The second group (Cohort B) will consist of men undergoing the same treatment but who are scheduled to receive only 6 months of treatment.
- The following tests and procedures will be performed when the participant joins the study, then at 3, 6, 12 and 24 months thereafter. (All visits will take place at the General Clinical Research Center (GCRC) at the Massachusetts General Hospital.) Height and weight; blood and urine samples; Oral Glucose Tolerance Test (OGTT), Dual energy X-ray Absorptiometry scan; medical history; and physical examinations.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Adenocarcinoma of the prostate, clinical stage M0
- •Scheduled to initiate GnRH agonist therapy with intended treatment duration of greater than 24 months (Group A)
- •Scheduled for radiation therapy and neoadjuvant GnRH agonist therapy with intended 6 month duration of treatment (Group B)
- •Karnofsky Performance Status 90 or 100
- •Local or local-regional disease (Group B)
排除标准
- •Prior hormone therapy (GnRH agonist or antiandrogen)
- •History of bilateral orchiectomy
- •Known diabetes mellitus or glucose intolerance
- •Current treatment with anabolic agents or metabolic agents known to affect insulin or glucose levels
研究组 & 干预措施
Group 1
GnRH agonist for 24 months
干预措施: Gonadotropin Releasing Hormone Agonist Therapy (Drug)
Group 2
GnRH agonist for 6 months
干预措施: Gonadotropin Releasing Hormone Agonist Therapy (Drug)
研究者
Matthew R. Smith, MD, PhD
Director, Genitourinary Malignancies Program
Massachusetts General Hospital