Prospective Multicenter Asian Observational Study of Oncological and Functional Outcomes After Focal Therapy of Prostate Cancer
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 500
- 试验地点
- 1
- 主要终点
- Overall Survival
研究概览
简要总结
This is a multicenter observational study of patients undergoing focal therapy for prostate cancer in Asia
详细描述
Patients undergoing Focal Cryotherapy, Focal HIFU, Focal IRE, Focal Laser ablation, or other partial gland ablation modalities for prostate cancer will be recruited.
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
- 40 Years 至 85 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Prostate Adenocarcinoma
- •Maximum Gleason score 4+4
- •Maximum cancer volume 1.5 ml (up to 2 lesions) or 3 ml (single lesion)
- •Maximum Prostate Specific Antigen (PSA) level 15 ng/dl
- •Maximum clinical stage T2c
- •American Society of Anesthesiologist Criteria 2 or less
排除标准
- •Extra-prostatic Extension on multi parametric magnetic resonance imaging (mpMRI); capsular contact is permitted
结局指标
主要结局
Overall Survival
时间窗: 20 years
Living at 20 years after treatment
Metastasis-Free Survival
时间窗: 20 years
Metastasis Free at 20 years after treatment
Progression-Free Survival
时间窗: 20 years
Progression-Free (Local or Systemic) at 20 years after treatment
Sexual Function
时间窗: 12 months
Change in Expanded Prostate Index Composite (EPIC) Sexual Summary Score (0-100, with 100 being the maximum) post-Focal Therapy (FT) compared to baseline at 1,3, 6, 12 months
Urinary Function
时间窗: 12 months
Change in Expanded Prostate Index Composite (EPIC) Urinary Summary Score (0-100, with 100 being the maximum) post-FT compared to baseline at 1,3, 6, 12 months
Short-term Clinically Significant Prostate Cancer Recurrence
时间窗: 18 months
12-18 month infield and outfield recurrence rate
Intermediate-term Clinically Significant Prostate Cancer Recurrence
时间窗: 5 years
5 year infield and outfield recurrence rate
Bowel Function
时间窗: 12 months
Change in Expanded Prostate Index Composite (EPIC) Bowel Summary Score (0-100, with 100 being the maximum) post-FT compared to baseline at 1,3, 6, 12 months
Treatment Failure-free Survival
时间窗: 5 years
Free of Radical Prostatectomy, Radiation, Whole-gland Ablation, Hormonal Therapy to Transition to Watchful Waiting at 5 years
Radical Intervention-free Survival
时间窗: 5 years
Free of Radical Prostatectomy or Radiation at 5 years
次要结局
- Failure-Free Survival(20 years)
- Intervention-Free Survival(20 years)
- Radical Intervention-Free Survival(20 years)