Docetaxel Plus 6-month Androgen Suppression and Radiation Therapy Versus 6-month Androgen Suppression and Radiation Therapy for Patients With High Risk Localized or Locally Advanced Prostate Cancer: A Randomized Controlled Trial
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 350
- 试验地点
- 1
- 主要终点
- 10-Year Restricted Mean Survival Time for Overall Survival
研究概览
简要总结
This randomized study is looking at the benefits of using docetaxel (chemotherapy) added to one of the standard treatments (radiation and hormones) for men with high-risk prostate cancer.
详细描述
Radiation therapy plus six months of hormone therapy is one standard way of treating men with high-risk prostate cancer. In this study, we want to see whether or not adding the chemotherapy drug docetaxel (Taxotere)will make this treatment more effective. Docetaxel has shown a benefit in median survival when given to men who have become resistant to hormonal therapy and in men who have metastatic prostate cancer (spread to other areas of the body).
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
- 30 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Biopsy proven prostate cancer
- •Clinical Tumor Category T1b, T1c, T2a and PSA greater than (>) 10 or Gleason score equal or greater than 4+3=7 or PSA velocity > 2.0 ng/ml per year and also eligible patients with tumor category T2c, T3a, T3b, or T4 as per 2002 AJCC guidelines. Any minor tertiary grade of Gleason 5; Biopsy Proven or Radiographic (erMRI Seminal Vesicle Invasion); Gleason = or > 3+4=7 with 50% or more cores positive
- •Negative bone scan
- •Lymph node assessment by CT or MR
- •Adequate hematologic function (Blood Counts)
- •Adequate liver functions (blood tests)
- •ECOG performance Status 0 or 1
- •Peripheral neuropathy must be =< grade 1
- •PSA obtained within 3 months of entry
排除标准
- •Prior history of malignancy that are < 5 years except for cancers found to be "in-situ" and would not likely impact a patient's life expectancy with appropriate medical management.
- •Prior pelvic radiation therapy
- •Prior hormonal therapy (up to 4 weeks prior to enrollment allowed)
- •Individuals unable to tolerate lying still 5 - 10 minutes
- •Patients with a history of severe hypersensitivity reaction to docetaxel or other drugs formulated with polysorbate 90.
研究组 & 干预措施
Arm1: Androgen Suppression Therapy + Radiation Therapy
Androgen Suppression Therapy and Radiation therapy
干预措施: Androgen Hormonal Suppression and Radiation (Drug)
Arm1: Androgen Suppression Therapy + Radiation Therapy
Androgen Suppression Therapy and Radiation therapy
干预措施: Androgen Suppression Therapy and Radiation Therapy (Drug)
Arm 2: Docetaxel + Androgen Suppression Therapy + Radiation Therapy
Docetaxel plus androgen suppression therapy and radiation therapy
干预措施: Docetaxel (Drug)
Arm 2: Docetaxel + Androgen Suppression Therapy + Radiation Therapy
Docetaxel plus androgen suppression therapy and radiation therapy
干预措施: Androgen Hormonal Suppression and Radiation (Drug)
Arm 2: Docetaxel + Androgen Suppression Therapy + Radiation Therapy
Docetaxel plus androgen suppression therapy and radiation therapy
干预措施: Androgen Suppression Therapy and Radiation Therapy (Drug)
结局指标
主要结局
10-Year Restricted Mean Survival Time for Overall Survival
时间窗: Following the end of RT patients were seen for follow up every 6 months for 5 years and annually thereafter, 10 years.
Overall survival (OS) was measured from the date of random assignment to death from any cause, censored at the date of last follow-up in surviving patients. The 10-Year Restricted Mean Survival Time was calculated as the area under the Kaplan Meier plot for OS, from randomization to 10-years follow-up
次要结局
- Number of Participants With Acute Adverse Events(During study treatment or within 30 days of the last dose of study, up to 7.2 months from randomization)
- 10-year Prostate Cancer Mortality(Following the end of RT patients were seen for follow up every 6 months for 5 years and annually thereafter, 10 years.)
- 10-year Biochemical Recurrence (PSA Failure)(PSA was measured following the end of RT, then every 6 months for 5 years and annually thereafter, 10 years)
- Number of Participants With Late Adverse Events, Any Grade and Attribution(Every 6 months post radiation therapy for 5 years (+/-90 days), then annually, up to 13.9 years from randomization)
研究者
Anthony V. D'Amico, MD, PhD
Principal Investigator
Dana-Farber Cancer Institute