HoLEP Prior to Radiation Therapy for Patients With LUTS/Retention and Concurrent Prostate Cancer
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Improvement in Quality of Life - Five Years Post Operatively
研究概览
简要总结
To determine if holmium laser enucleation of the prostate (HoLEP) for the treatment of lower urinary tract symptoms (LUTS) and/or urinary retention alters the treatment course for patients concurrently diagnosed with prostate cancer.
详细描述
The investigators propose a prospective trial to investigate pre-radiation holmium laser enucleation (HoLEP) in men with bothersome lower urinary tract symptoms (LUTS) and prostate cancer who have elected for radiation therapy as the primary treatment modality for their prostate cancer. The investigators hypothesize that pre-radiation HoLEP may decrease their overall LUTS and may decrease their need for subsequent radiation therapy. The goal with this study is to better understand the overlap between prostate cancer and LUTS, as well as determine if primary surgical treatment for the LUTS with HoLEP can also serve as a possible treatment modality for concurrent prostate cancer. This information may provide further information to inform future standard of care practices for patients with prostate cancer.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients must be 18 years of age or older
- •Patients must have bothersome lower urinary tract symptoms (LUTS), defined by American Urological Association Symptom Score (AUA SS) of greater than or equal to 15 and/or as defined by a post-void residual of greater than or equal to 350mL and/or as defined by catheter dependence
- •Patients must be diagnosed with prostate cancer by pathological tissue analysis
- •Patients must have elected for radiation with androgen deprivation therapy as the primary treatment modality for their prostate cancer
排除标准
- •Patients who are under 18 years of age are not eligible
- •Patients who have a diagnosis of bladder cancer are not eligible.
- •Patients with prior treatment for prostate cancer are not eligible.
- •Patients with any type of prior prostate surgery (minimally invasive, endoscopic, or otherwise) including prior transurethral resection of the prostate (but excluding prior prostate biopsy) are ineligible.
- •Patients with known metastatic prostate cancer are ineligible
- •Patients who are enrolled in other surgical or international trials at the time of this study are not eligible
研究组 & 干预措施
Holmium Laser Enucleation of Prostate (HoLEP)
Patients in this arm will undergo holmium laser enucleation of the prostate (HoLEP) for the treatment of lower urinary tract symptoms (LUTS). Patients will undergo HoLEP one time and will return for standard of care follow up.
干预措施: Holmium Laser Enucleation of Prostate (HoLEP) (Procedure)
Control Arm
Patients in this arm will undergo no additional interventions and will not undergo holmium laser enucleation of the prostate (HoLEP) for the treatment of lower urinary tract symptoms and instead follow standard of care treatment and follow up.
结局指标
主要结局
Improvement in Quality of Life - Five Years Post Operatively
时间窗: Quality of life will be assessed five years post-operatively
The primary object is to determine if holmium laser enucleation of the prostate (HoLEP) improves the quality of life in patients with concurrent prostate cancer who may undergo radiation therapy as well. Quality of life will be assessed using the Expanded Prostate Cancer Index Composite (EPIC) 26. This instrument evaluates patient function and bother after prostate cancer treatment using 26 items and scored on a 0-100 scale, with higher scores indicating a better health related quality of life.
Improvement in Quality of Life - One Year Post Operatively
时间窗: Quality of life will be assessed one year post-operatively
The primary object is to determine if holmium laser enucleation of the prostate (HoLEP) improves the quality of life in patients with concurrent prostate cancer who may undergo radiation therapy as well. Quality of life will be assessed using the Expanded Prostate Cancer Index Composite (EPIC) 26. This instrument evaluates patient function and bother after prostate cancer treatment using 26 items and scored on a 0-100 scale, with higher scores indicating a better health related quality of life.
次要结局
- Prostate Cancer Treatment Course - One Year Post Operatively(Prostate Cancer Treatment Course will assessed one year post-operatively)
- Prostate Cancer Treatment Course - Five Years Post Operatively(Prostate Cancer Treatment Course will assessed five years post-operatively)
研究者
Bristol Whiles, MD
Principal Investigator
University of Kansas Medical Center