Cryoablation: An Observational Study of Hemi-Gland Cryoablation Outcomes for Prostate Cancer at University of California at Los Angeles (UCLA)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 354
- 试验地点
- 2
- 主要终点
- Clinical Response to Cancer Treatment
研究概览
简要总结
This is a prospective data collection of men who are electing to undergo prostate hemi-gland cryoablation.
The purpose of this observational research study is to investigate the localized treatment of prostate cancer using hemi-gland cryoablation.
UCLA patients undergoing hemi-gland cryoablation are a unique cohort compared to prior research because all patients at UCLA have had a pre-treatment multi-parametric MRI and Ultrasound fusion targeted biopsy; they will be followed in a similar fashion. This results in more precise assessment of a target region of cancer for ablation which may, in turn, result in improved clinical outcomes.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Patient has undergone or has elected to undergo hemi-gland cryoablation at UCLA
- •Low or intermediate risk prostate cancer (Gleason ≤ 7) or select high-risk patients (Gleason 8 prostate cancer).
- •Prostate volume of ≤ 70 cc
- •Ability to complete informed consent form
排除标准
- •Medical contraindication to follow-up multi-parametric magnetic resonance imaging (mpMRI) or prostate biopsy
- •Patients unable to tolerate general or regional anesthesia.
结局指标
主要结局
Clinical Response to Cancer Treatment
时间窗: 6 months
Our primary endpoint will be a patient's clinical response to cancer treatment, specifically, the degree of prostate cancer on a post-treatment fusion biopsy compared to pre-treatment.
次要结局
- Quality of Life Assessment - Urinary Function(6 months)