A 12 Month Open Label Study of Serum Testosterone Recovery and PSA After Neo-Adjuvant Treatment With Eligard(TM) 22.5mg Used With Radiation Therapy in Patients With Early Prostate Cancer
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 42
- 主要终点
- Serum Testosterone Recovery
研究概览
简要总结
The purpose of this study is to determine if testosterone will recover to 90% by year 1 after using Eligard.
详细描述
This is a Multi-center, open-label study to evaluate testosterone recovery after six months of neo-adjuvant treatment with ELIGARD (TM) 22.5mg used with Radiation Therapy in patients with TNM T1, T2 or T3A adenocarcinoma of the prostate. The 60 patients will receive two subcutaneous administration of ELIGARD (TM) 22.5mg (Baseline and Month 3) and receive Radiation Therapy (Month 2-4).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 50 Years 至 80 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Must be outpatient, not hospitalized
- •Male Patient between ages 50-80, inclusive
- •Histologically/Cytologically graded adenocarcinoma of the prostate
- •Must have T1, T2 or T3a adenocarcinoma of the prostate
- •Must be a candidate for radiation therapy. Hormone refractory patients excluded
- •WHO/ECOG score of 0,1 or 2
排除标准
- •NO evidence of urinary tract that would put the patient at risk in the opinion of the Investigator.
- •Used the following treatments for prostate Cancer
- •*immunotherapy *chemotherapy *External Beam Radiation *brachytherapy *hormonal therapy *biological response modifiers
- •Prior Prostate Surgery (excluding TUNA or TURP)
- •Undergone Orchiectomy, adrenalectomy, hypophysectomy or be receiving any product which could alter the function of these organs
- •Use of Investigational Drug, Biologic or device within five half-lives of its physiological action or three months prior to base line, whichever is longer
- •Over the counter or alternative medical therapies which have estrogenic or anti-androgenic effect
- •uncontrolled CHF within 6 months to baseline
- •Myocardial Infarct, coronary vascular procedure or Clinically SignificantCardiovascualr Disease within 6 months of baseline Visit
- •Venous thrombosis with in 6 Months of Screening
- •Uncontrolled Hypertension defined as >170/100 or Symptomatic Hypotension within 3 months of Baseline
- •Insulin dependant Diabetic Patients Must not administer in an anatomic region where they will receive Eligard.
- •Drug or Alcohol Abuse 6 months prior to Baseline
- •Other Serious Illness at the discretion of the Investigator
- •Patients receiving anti-coagulant or anti-platlet medication must be on a stable dose for 3 months prior to Baseline
- •Hypersensitivity to GnRH, GnRH agonists
研究组 & 干预措施
Eligard (TM)
Eligard (TM) administered 22.5mg
干预措施: Eligard (TM) (Drug)
结局指标
主要结局
Serum Testosterone Recovery
时间窗: 6 mos
To Evaluate the time to testosterone recovery, which is defined as a return to with in 90% of pretreatment level, after 6 months of neo-adjuvant treatment with Eligard 22.5mg with Radiation Therapy in patients with early prostate Cancer
次要结局
- Safety Assessments(6 months)