NCT00824928终止不适用
A Prospective Multicenter Registry of Salvage Cryotherapy in Recurrent Prostate Cancer Study
适应症
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 60
- 试验地点
- 17
- 主要终点
- Biochemical failure after treatment (defined as nadir PSA value + 2 ng/dl documented in the postoperative period).
研究概览
简要总结
To provide a systemic, uniform and user-friendly tool for collection of data on prostate cancer salvage cryotherapy in a multicenter setting. The goal is to learn more about the short and long term efficacy and safety of this procedure. Ultimately the data analysis will serve as a robust guidance instrument for improving upon the utilization of this procedure for the treatment of patients with recurrent (LRD) prostate cancer.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 30 Years 至 80 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Read & understand informed consent related to this study including consenting and HIPPA authorization
- •Undergone salvage cryotherapy of the prostate for recurrent prostate cancer
排除标准
- •Patients who underwent radical prostatectomy as their primary therapy or other significant surgery (except prostatic biopsy)
- •Patients with clinically confirmed distant metastasis (unless deemed beneficial by the treating physician)
- •Any previous major rectal surgery
- •Clinically significant lower urinary tract or rectal anomalies
- •Existing urethral, rectal, or bladder fistulae
结局指标
主要结局
Biochemical failure after treatment (defined as nadir PSA value + 2 ng/dl documented in the postoperative period).
时间窗: 3-6 months intervals during the first 2 years after the completion of the procedure and yearly thereafter unless is amended by the treating physician
次要结局
- Percentage change in QoL scores (EPIC) if available(3-6 months intervals during the first 2 years after the completion of the procedure and yearly thereafter unless is amended by the treating physician)
- Percentage change in AUA-symptom score (also referred to as IPSS score)(3-6 months intervals during the first 2 years after the completion of the procedure and yearly thereafter unless is amended by the treating physician)
- Percentage change in erectile dysfunction as measured by Sexual Health Inventory for men score (SHIM also referred to as IIEF score)(3-6 months intervals during the first 2 years after the completion of the procedure and yearly thereafter unless is amended by the treating physician)
- Percentage change in urinary symptoms (continence score)(3-6 months intervals during the first 2 years after the completion of the procedure and yearly thereafter unless is amended by the treating physician)
研究者
研究点 (17)
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