Vessel Sparing Prostate Radiation Therapy: Dose Limitation to Critical Erectile Structures (Corpus Cavernosum and Internal Pudendal Artery) by MRI Based Treatment Planning
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 135
- 试验地点
- 1
- 主要终点
- The Percentage of Patients Able to be Sexually Active With or Without the Use of Aids
研究概览
简要总结
Prostate cancer patients have a number of excellent treatment options to consider, and quality of life following treatment is often a consideration in treatment choice. One critical quality of life concern for patients diagnosed with prostate cancer is sexual function. Previous studies point to a vascular mechanism of impotence post-radiation therapy, as opposed to a nerve-based mechanism following surgery. In this study, the critical vascular structures (internal pudendal artery and corpus cavernosum) are defined by MRI-based imaging and included in treatment planning for radiation treatments, hopefully preserving critical artery function. This study will collect erectile function preservation rates at 5-years post-vessel-sparing radiotherapy with or without aids using the patient reported using the simplified three-question erectile function scale.
详细描述
The vast majority of patients diagnosed with prostate cancer in the modern era of PSA screening have localized and potentially curable disease. Patients have a number of excellent treatment options to consider, and quality of life following treatment is often a consideration in treatment choice. One critical quality of life concern for patients diagnosed with prostate cancer is sexual function. Studies of sexual function post-radiation therapy fall into three categories: incidence studies; correlative (dose and toxicity) studies; mechanism(functional) studies. All these studies point to a vascular mechanism of impotence post-radiation therapy, as opposed to a nerve-based mechanism following surgery. In this study, the critical vascular structures (internal pudendal artery and corpus cavernosum) are defined by MRI-based imaging and included in treatment planning for radiation treatments. Investigators propose that this technique will improve quality of life, sexual function, and relapse-free survival.
This study's primary aim is to determine erectile function preservation rates at 5-years post-vessel-sparing radiotherapy with or without aids using the patient reported using the simplified three-question erectile function scale.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •Histologically confirmed diagnosis of prostate cancer
- •Patients must have measurable erectile function. Patients with erectile function on Viagra and drugs of the same class are eligible. Patients who require 6 months of hormonal therapy or less are eligible, provided baseline erectile function is measured prior to or within 14 days of the start of hormonal therapy.
- •Baseline PSA (Prostate Specific Antigen), TNM stage (a classification of malignant tumors in cancer), and Gleason Score (A system of grading prostate cancer tissue based on how it looks under a microscope): Patients with low (PSA less than 10, T2a or less, Gleason 6 or less), intermediate, or high (Gleason 8-10, T3a, PSA over 20) risk disease are eligible for this protocol. Patients on finasteride or drugs of the same class are eligible.
- •Patients must be 18 years or older. No upper age restriction.
- •Patients treated with external beam radiotherapy alone or external beam therapy plus implant therapy are eligible.
- •Patients must have an ECOG (Eastern Cooperative Oncology Group system of grading patient status that attempts to quantify cancer patients' general well-being and activities of daily life) performance status <
- •The patient must sign study specific informed consent approved by the IRB of U of M indicating they are aware of the investigational nature of the treatment.
排除标准
- •Patients who are impotent or have an IIEF (International Index of Erectile Function) <
- •Patients who are medically ineligible for radiation therapy due to other medical conditions.
- •Patients given hormonal therapy before baseline questionnaires filled out.
- •Patients who receive implant only therapy.
- •Patients unable to undergo MRI (Magnetic Resonance Imaging).
研究组 & 干预措施
Intervention
Vessel Sparing Radiation Therapy using MRI based treatment planning to limit dose to critical erectile structures
干预措施: Radiation Therapy (Radiation)
结局指标
主要结局
The Percentage of Patients Able to be Sexually Active With or Without the Use of Aids
时间窗: 5 years from end of radiation treatment
The primary endpoint of the study was to accurately determine the preservation of erectile function post radiation therapy. Erectile preservation was defined as a score of 1 or 2 on the three-tier patient reported questionnaire equating to being able to be sexually active with or without aids. Scoring: 1. Sexually active without aids 2. Sexually active with aids 3. Not sexually active with or without aids
次要结局
未报告次要终点