Transperineal Laser Ablation Treatment for Prostate Cancer Registry: a Retrospective and Multicenter Evaluation
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Oncological control
研究概览
简要总结
Rationale: Transperineal laser ablation (TPLA) treatment for prostate cancer (PCa) is a minimal invasive focal therapy technique studied worldwide to determine its efficacy. In pilot studies it has shown to be a safe and feasible technique and it has potential to preserve continence and potency over current standard radical therapies. However, (long-term) treatment outcomes of TPLA for PCa remain largely unknown. The aim of this international retrospective registry is to collect and combine data on patients treated TPLA for PCa in order to provide data on safety, feasibility, functional and oncological outcomes.
Objective: To assess safety and feasibility of TPLA for PCa, to assess functional and oncological outcomes of TPLA for PCa and to determine baseline patient characteristics in a multicentre cohort.
Study design: This is an international, retrospective observational registry in which data is recorded of patients who have been treated with TPLA for PCa.
Study population: Male patients treated with TPLA for PCa. Main study parameters/endpoints: The primary endpoint of this registry is oncological outcomes of TPLA for PCa. Secondary endpoints are safety, feasibility and functional outcomes of TPLA for PCa.
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 —(Adult, Older Adult)
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Male, histological-confirmed disease of localized prostate cancer, TPLA treatment for PCa is performed
排除标准
- •Age < 18 years
结局指标
主要结局
Oncological control
时间窗: 12 months
Oncological control is defined as: a PSA \<=2.0ng/mL than initial PSA and/or no residual tumor or other lesion suspicious for prostate cancer on magnetic resonance imaging and/or no gleason score upgrading on re-biopsy and/or no clinical up-staging of prostate cancer T-stage
次要结局
- PROM regarding voiding(12 months)
- PROM regarding erectile function(12 months)
- Safety of TPLA for PCa(Up to 12 weeks)
- Potency rate(12 months)
- Continence rate(12 months)
- Urinary flow(12 months)
- Feasibility of TPLA for PCa(Up to 4 weeks)
研究者
Prof.dr. H.P. Beerlage
Professor
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
