A Phase II Trial of Samarium 153 Followed by Salvage Prostatic Fossa 3D-CRT or IMRT Irradiation in High-Risk, Clinically Non-Metastatic Prostate Cancer After Radical Prostatectomy
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 67
- 试验地点
- 29
- 主要终点
- Proportion of Patients With PSA Response (pt) Within 12 Weeks of Samarium 153 Administration
研究概览
简要总结
RATIONALE: Giving samarium Sm 153 lexidronam pentasodium and 3-dimensional (3-D) conformal radiation therapy or intensity-modulated radiation therapy may keep prostate cancer from growing in patients with rising prostate-specific antigen (PSA) levels after radical prostatectomy for prostate cancer.
PURPOSE: This phase II trial is studying how well samarium Sm 153 lexidronam pentasodium and 3-D conformal radiation therapy or intensity-modulated radiation therapy work in treating patients with rising PSA levels after radical prostatectomy for prostate cancer.
详细描述
OBJECTIVES:
Primary
- To assess the effectiveness of samarium Sm 153 lexidronam pentasodium (as determined by a 30% decline in the PSA level within 12 weeks) followed by either three-dimensional conformal radiation therapy or intensity-modulated radiation therapy in patients with rising prostate-specific antigen levels (PSA) after radical prostatectomy prostate cancer.
Secondary
- To assess the proportion of patients completing protocol treatment.
- To evaluate hematological toxicity at 12 weeks.
- To evaluate samarium Sm 153 lexidronam pentasodium-related adverse events at 12 weeks.
- To evaluate the "acute" and "late" radiation therapy-related events having occurred up to 24 weeks from the end of radiation therapy.
- To compare the freedom from progression rate at 2 years to that predicted by the Kattan Nomograms.
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
- 18 Years 至 120 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Radiotherapy + Samarium 153
Samarium 153 infusion followed by radiotherapy 12 weeks later
干预措施: Radiotherapy (Radiation)
Radiotherapy + Samarium 153
Samarium 153 infusion followed by radiotherapy 12 weeks later
干预措施: Samarium 153 (Drug)
结局指标
主要结局
Proportion of Patients With PSA Response (pt) Within 12 Weeks of Samarium 153 Administration
时间窗: Twelve weeks from the date of Samarium 153 infusion.
A PSA response for each patient is calculated by (baseline PSA-current PSA)/baseline PSA. A decline of at least 30% is considered a response. Null hypothesis (H0): Samarium 153 is not effective (pt ≤ 0.1) vs alternative hypothesis (HA): Samarium 153 is effective (pt ≥ 0.25). The sample size of 69 analyzable patients (eligible patients receiving any protocol treatment with ≥ 12 weeks follow-up from the Samarium 153 injection) was calculated based on Fleming's Multiple Testing Procedure at a significance level of 0.019 and 91% statistical power requiring 69 patients to conclude either the null or alternative hypotheses. With only 52 analyzable patients this study had only 78% power and needed at least 11 patients with a PSA response to reject H0.
次要结局
- Completion of Therapy(90 days from the end of radiation therapy.)
- Acute and Late Radiotherapy-Related Adverse Events(90 days from start of radiotherapy)
- Number of Patients With Hematologic Toxicity at 12 Weeks(Twelve weeks from the date of Samarium 153 infusion.)
- Samarium 153-related Adverse Events at 12 Weeks (Percentage of Patients)(Twelve weeks from the date of Samarium 153 infusion)
- Freedom From Progression (FFP) Rate at 2 Years(From randomization to 2 years)