NCT00703768Unknown不适用
An Open-Label, Phase ll Trial Comparing FACT-P Scores For Subjects Who Are Indicated To Receive Androgen Deprivation Therapy And Have A Doubling In PSA Post Curative Therapy Of Either Less Than Or Greater Than One Year
Urology South Shore Research Inc.1 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2006年6月最近更新:
适应症
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- Significant difference in FACT-P scores after 12 months between the 2 groups
研究概览
简要总结
The purpose of this study is to evaluate if there is a difference in quality of life (as measured by FACT-P) in patients treated with androgen deprivation therapy (ADT) for biochemical failure (PSA recurrence) following surgery or radiation for prostate cancer depending on when ADT is initiated.
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
- Female
- 接受健康志愿者
- 否
入选标准
- •18 years or older
- •Received therapy of curative intent (surgery or radiotherapy)
- •Have a rising PSA which has doubled from a nadir value.
- •Histologically proven prostate cancer requiring androgen deprivation therapy for at least 12 months
- •Written informed consent to participate in the trial.
排除标准
- •Known hypersensitivity to Zoladex, Casodex, ar any component of these products
- •Prior treatment with LHRH agonist or anti-androgens in the past 12 months
- •Any concomitant condition that would make it undesirable, in the physician's opinion, for the subject to participate in the trial or would jeopardize compliance with the protocol.
结局指标
主要结局
Significant difference in FACT-P scores after 12 months between the 2 groups
时间窗: 12 months
次要结局
- PSA response(12 months)
- To evaluate the ease of use of FACT-P to measure Quality of Life(12 months)
- QOL, side effect profile and evaluate the safety and tolerability of Androgen Deprivation Therapy(12 months)
研究者
研究点 (1)
Loading locations...
相似试验
已完成
2 期
A Study on Efficacy (Effectiveness), Safety, and Impact on Quality of Life Measures of Dilaudid CR (Controlled Release);, Hydromorphone HCl in Patients With Chronic Low Back PainLow Back PainNCT00398788Alza Corporation, DE, USA207
已完成
3 期
Safety, Effectiveness, and Impact on Quality of Life on Long-Term Administration of OROS Hydromorphone Slow-Release in Patients With Chronic Low Back PainLow Back PainNCT00411268Alza Corporation, DE, USA207
已完成
不适用
Comparative Effectiveness Research Study of Peripheral Arterial Disease (PAD)ClaudicationPeripheral Arterial DiseaseNCT01378260University of Washington323
终止
2 期
Quality of Life Study Using Gabapentin Versus Venlafaxine in Treating Hot Flashes in Patients With Prostate CancerProstate CancerNCT01533753University of Wisconsin, Madison5
已完成
4 期
A Study to Evaluate the Effect of Advagraf Conversion From Prograf in Liver Transplant Subjectsde Novo Liver Transplant SubjectsNCT01882322Astellas Pharma Korea, Inc.36