NCT03129854招募中不适用
A Randomized Study of Androgen Deprivation Therapy Versus Androgen Deprivation Therapy Plus Prostate Cryotherapy in the Treatment of Patients With Primary Diagnosed Metastatic Prostate Cancer
Sun Yat-sen University1 个研究点 分布在 1 个国家目标入组 250 人开始时间: 2017年3月29日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 250
- 试验地点
- 1
- 主要终点
- Prostate Cancer Progression-Free Survival
研究概览
简要总结
Patients with primary diagnosed metastatic prostate cancer are randomly divided into two groups. One group receive standard of care ADT continually. Another group receive ADT plus prostate cryotherapy. Patients are followed up until their death or withdraw from this study due to other reasons. The primary endpoint of this study is prostate cancer Progression-Free Survival. The secondary endpoint is overall survival, prostate cancer specific survival and health-related quality of life.
详细描述
Ages Eligible for Study: 18 Years and older.
Genders Eligible for Study: Male.
Accepts Healthy Volunteers: No.
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 90 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Have histologically diagnosed prostate cancer
- •Metastatic disease diagnosed by CT scan, MRI scan or bone scan. M stage M1a or M1b according to 2010 American joint Committee on Cancer (AJCC) stage system
- •Be willing and able to provide written informed consent/assent for the trial
- •Eastern Cooperative Oncology Group (ECOG) performance scale status of 0 or 1
- •Calculator of overall mortality risk at 3 years less than 70%( Eur Urol. 2016 May
- •pii: S0302-2838(16)30141-
- •Time interval between hormonal therapy and randomization less than 6 months
- •Can tolerate general anesthesia and cryosurgery
- •Demonstrate adequate organ function
排除标准
- •According to the doctor's judgment, the patients had any serious illness or other clinical conditions, can't safely undergo the clinical research, any other serious diseases or clinical situation is not limited to the items listed below:
- •Infection ≥ grade 2 according to National Cancer Institute on the common terminology criteria for adverse events (NCI-CTCAE) version 4.03,
- •Heart failure (New York heart group NYHA) III or IV,
- •Crohn's disease or ulcerative colitis,
- •Fecal incontinence,
- •Substance abuse, medical, psychological or social problems that may interfere with the evaluation of the results of this study,
- •The presence of any unstable disease or clinical condition, potential harm to the safety of the subject or influence the subject's compliance.
- •Other malignancies (within 5 years), except for non melanoma skin cancer. Patients with other malignancies who survived with effective treatment and randomized to have no evidence of cancer for more than 5 years were allowed to participate in the study
- •Treatment of prostate cancer other than hormonal therapy (except bisphosphonate therapy for bone metastases)
- •After 6 months of hormonal treatment, the prostate volume greater than 55ml
结局指标
主要结局
Prostate Cancer Progression-Free Survival
时间窗: through study completion, an average of 48 months
Prostate Cancer Progression-Free Survival (PFS), from beginning of ADT to progression of prostate cancer
次要结局
- prostate cancer specific survival(through study completion, an average of 60 months)
- Overall Survival(through study completion, an average of 60 months)
- Functional Assessment of Cancer Therapy-Prostate(through study completion, an average of 48 months)
研究者
Yonghong Li
Principal Investigator
Sun Yat-sen University
研究点 (1)
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