A Multicenter, Randomized Clinical Investigation of Trelstar Versus Continued Therapy in Patients Receiving Lupron or Zoladex for Advanced Prostate Cancer
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 发起方
- Pharmatech
- 入组人数
- 41
- 试验地点
- 11
- 主要终点
- Maintenance of serum testosterone at or below castration level (50ng/dL)
研究概览
简要总结
This research study looks at Testosterone levels in patients receiving Trelstar versus those receiving Lupron or Zoladex. These drugs have been approved for treatment of Prostate Cancer by the FDA.
详细描述
Patients who are currently receiving Lupron or Zoladex will be consented and then randomized to receive either continued treatment with the drug they have been on, or will be randomized to Trelstar for a period of 3 months. At the end of that period, testosterone and prostate serum antigen (PSA) levels will be drawn and compared to their previous levels to determine if Trelstar is as effective as the previous treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
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
- •Advanced Prostate Cancer
- •Currently taking Lupron or Zoladex
- •Stable PSA
- •Baseline testosterone below castration level
- •Life expectancy > 6 months
- •Eastern Cooperative Oncology Group performance status of 0-2
- •Signed, approved informed consent.
排除标准
- •Known hypersensitivity to any leuteinizing hormone releasing hormone (LHRH) agonist
- •Ongoing therapy with hyperprolactinemic agents
- •Antiandrogen therapy within 28 days prior to study start
- •Prior Orchiectomy, hypophysectomy or adrenalectomy
- •Chemotherapy, radiotherapy, or prostatectomy within 28 days prior to study start
- •Use of any investigational agent 3 months prior to enrollment
- •Use of systemic corticosteroids within 28 days or during study
- •Other malignancies within 2 yrs prior to study start, except curatively treated skin cancers
- •Severe kidney or liver failure, based on adequate lab values
- •Other medical conditions which would be likely to interfere with compliance or completion of study requirements
研究组 & 干预措施
Trelstar
Per prescribing information
干预措施: Trelstar (Drug)
Lupron
Per prescribing information
干预措施: Lupron (Drug)
Zoladex
Per prescribing information
干预措施: Zoladex (Drug)
结局指标
主要结局
Maintenance of serum testosterone at or below castration level (50ng/dL)
时间窗: 12 weeks
Primary efficacy
次要结局
- Serum testosterone level at end of study(Week 12)
- Incidence and severity of adverse events(12 weeks)
- Change in serum testosterone from baseline to end of study(Baseline and week 12)