NCT00921258终止不适用
Active Control of Prostatic Cancer With Criteria of Latence. Impact on Specific 10 Years Survival.
Clinique Mutualiste Chirurgicale de la Loire15 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2007年12月最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 100
- 试验地点
- 15
- 主要终点
- Evaluates specific survival to 10 years
研究概览
简要总结
This study concern a prospective cohort pf patients with latent prostate cancer. We study the specific survival at 10 years of patients who accept an active control.Patients inclusion are realized in 2 stages:
- patient with inclusion criteria (PSA < 10 ng/ml, clinical stage T1c or T2a, Gleason < or = 6) are registered if they accept a second prostate biopsy in a 3 months delay
- after analyse of second biopsy in central laboratory and confirmation of latent prostate biopsy, patients are included if they accept active control Included patients will have 1 biopsy by years the first two years and then 1 biopsy each 2 years during 8 years.
If progression of cancer happens during the 10 years control, active control will be stopped and patient will be treated by surgery and chemotherapy.
详细描述
This study concern the active control during 10 years of patient with latent prostate cancer who accept not be treated immediately.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 74 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •patient with a latent prostatic cancer
- •aged less 75 years old,
- •life expectation higher than 10 years
- •Clinic statue T1c or T2a
- •with a seric PSA (prostatic specific antigen)smaller than 10ng/ml
- •more than 10 biopsy cores samples
- •patient with less than 3 cores samples with tumor and none care sample with more than 3mm of tumor
- •Gleason score inferior at 7
- •patient's agreement about project and a second biopsy which will include definitive patient: realized 3 months after the first and having: 14 biopsy cores samples (10 like previously and 4 more specific: taking around the positives initials biopsies), less than 3 cores samples with tumor, ,any cores samples with more than 3mm of tumor, a Gleason score superior at 7.
排除标准
- •patient aged 75 years old and more
- •no patient's agreement
- •lack of understanding of plan
- •patient with guardianship
- •life expectation smaller than 10 years
- •patient with an other cancer less than 5 years
- •Local clinical statue greater than T2a
- •seric PSA higher than 10ng/ml
- •less than 10 biopsies
- •more than 2 positives biopsies during the first intervention
- •3 cores samples with more than 3mm of tumor
- •4th grade on the biopsies
- •patient's refuse to realize the second biopsies
- •patient who ask a treatment after the first medical examination
- •patient with less 4 special biopsies around the previously initial cores samples or more than 2 positives biopsies or biopsies with more than 3mm of tumor or patient having a 4 grade on biopsies, during the second medical examination.
结局指标
主要结局
Evaluates specific survival to 10 years
时间窗: 10 years
次要结局
- To evaluate global survival of patient in control(10 years)
- To evaluate the survival of patient with a secondary active treatment after a control period(10 years)
- To evaluate delay to secondary treatment after a period control(10 years)
- To evaluate acceptation of 2nd biopsy to confirm latent cancer(10 years)
- To evaluate survival rate without biological or clinical progression of cancer(10 years)
- To evaluate quality of life(10 years)
研究者
研究点 (15)
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