A Prospective, Multi-Institutional, Randomized, Phase II Trial of Best Systemic Therapy or Best Systemic Therapy (BST) Plus Definitive Treatment (Radiation or Surgery) of the Primary Tumor in Metastatic (M1) Prostate Cancer (PC)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 180
- 试验地点
- 8
- 主要终点
- Progression-Free Survival
研究概览
简要总结
The goal of this clinical research study is to learn if treatment with standard systemic therapy (androgen deprivation therapy or bilateral orchiectomy) in combination with surgery or radiation therapy is more effective at controlling prostate cancer than standard systemic therapy alone. The safety of this treatment combination will also be studied.
详细描述
Study Groups:
If you are found to be eligible to take part in this study, you will be randomly assigned (as in the flip of a coin) to 1 of 2 study groups at 6 months (+/- 14 days) from starting standard systemic therapy. You will have an equal chance of being assigned to each group.
- If you are in Group 1, you will continue to receive standard of care systemic treatment.
- If you are in Group 2, you will receive standard of care systemic treatment in addition to surgery to remove your prostate or radiation therapy to the prostate. You and your treating physician will decide if surgery or radiation therapy is the best choice for you. Your treating physician will explain the surgery or radiation therapy and their risks to you in more detail, and you will be asked to sign a separate consent form for the procedure.
If the disease gets worse within the first 6 months of receiving standard systemic therapy, you will not be assigned to a study group. You may be able to continue receiving standard systemic therapy if your doctor thinks it is in your best interest. You may choose to participate in this study by allowing the study team to collect information about you at the following study visits described below: within 60 days of screening, end-of-treatment, and long-term followup.
Study Visits:
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
- •Male patients
- •18 yrs and older
- •Histologically or cytologically proven prostate carcinoma
- •Documented evidence of M1 disease by AJCC (American Joint Committee on Cancer) staging by Bone scan, CT and/or MRI.
- •Androgen dependent disease measured by declining PSA and do not display signs of progression demonstrated by a rising PSA.
- •Treatment initiation with BST no longer than 6 months prior to randomization
- •ECOG PS 0 or 1
- •Life-expectancy based on comorbid conditions >2 years
- •Ability to understand and willingness to sign informed consent
- •Must be a candidate for surgery and/or radiation therapy
排除标准
- •Psychiatric or medical conditions which, in the opinion of the treating physician, would not allow the patient to undergo the proposed treatments safely.
- •Known brain metastasis
- •Small cell carcinoma of the prostate
- •Any laboratory abnormalities, which in the opinion of the investigator, may put the subject at risk if participating in the study. For example: AST + ACT > 2 upper limits of normal value; WBC < 2.0; Hgb < 7.0.
结局指标
主要结局
Progression-Free Survival
时间窗: 60 days
Primary endpoint is progression-free survival, defined as the time interval from the start of initial best systemic therapy (BST) treatment to the date of disease progression or death, whichever occurred first.
次要结局
未报告次要终点