Phase III, Open-Label Study to Evaluate Efficacy and Safety of Histrelin Subdermal Implant in Patients With Advanced Prostate Cancer
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 138
- 主要终点
- Suppression of testosterone to chemical castration levels (<= 50 ng/dL)
研究概览
简要总结
Objective was to evaluate the efficacy and safety of the histrelin acetate subdermal implant (originally versus Lupron Depot-3 Month) in male patients with advanced prostate cancer during 52 weeks of treatment with the implant. After consultation w/ FDA, design was modified to eliminate the Lupron arm and continued the study as an open-label non-randomized study.
Primary endpoint was testosterone suppression, as assessed by the percent of patients whose testosterone indicated chemical castration levels (<=50 ng/dL) through 52 weeks of treatment with an implant.
详细描述
Other outcome measures included serum levels of LH, PSA, as well as non-clinical assessments, eg, WHO Performance Status, pain level assessment, and quality of life questionnaires. Safety was evaluated via adverse events, vital signs, clinical laboratory outcomes, physical examinations, and ECGs. Local tolerability outcomes were also evaluated.
An extension period for the study included annual replacement of the implant until the implant was approved by the FDA (October 12, 2004). Efficacy and safety were followed during the extension period.
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
- 45 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Male Age 45 or older
- •Histologically confirmed adenocarcinoma of the prostate
- •Disease Staging III or IV
- •Clinical indication for androgen suppression therapy
- •Serum testosterone at least 150 ng/dL at screening
- •WHO Performance Scale 0 to 3
- •Life expectancy of at least one year
排除标准
- •Bilateral orchiectomy
- •Prior androgen-ablative therapy within past year
- •Second malignancy with 5 years (except adequately treated non-melanomatous skin cancer or superficial bladder cancer)
- •Spinal cord compression
研究组 & 干预措施
one histrelin acetate 50 mg implant
The test product was a histrelin acetate 50 mg hydrogel implant surgically placed subdermally into the inner aspect of the upper arm.
干预措施: histrelin acetate (Drug)
结局指标
主要结局
Suppression of testosterone to chemical castration levels (<= 50 ng/dL)
时间窗: 52 weeks
次要结局
- Pain measurements(52 weeks)
- PSA measurements(52 weeks)
- QoL outcomes(52 weeks)