The Long Term Effect of MRI Before Radical Prostatectomy.
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 438
- 主要终点
- Disease-free survival (DFS)
研究概览
简要总结
A randomized clinical trial conducted by Oslo University Hospital between 2010 and 2012 included 438 patients with prostate cancer to the non-MRI group (216) or the MRI group (222) before robot-assisted radical prostatectomy (RALP). The primary endpoint was to compare the nerve-sparing surgery types and the proportion of positive surgical margins (PSM) in each group. The MRI group underwent more non-nerve sparing surgery, whereas the proportion of PSM was similar in both groups (p=0.4) [1]. Since the long-term effects of preoperative MRI are unknown, we aimed to assess the variations in the long-term functional and oncological outcomes between the groups.
详细描述
The aim of this study was to evaluate the oncological and functional outcomes in a 12-year follow-up after RALP in patients preoperatively randomized to no-MRI or MRI.
Material: a total of 438 consecutive patients were referred to RALP. Of these, 222 were randomized to preoperative MRI (intervention group), and 216 were randomized to no MRI (control group). All underwent radical prostatectomy between 2010 and 2012.
Study design: An experimental interventional study with 12-years follow-up
Endpoints: PSA recurrence (PSA ≥0.2ng/ml) Predictors for PSA recurrence (PSM, DÁmico risk group, Gleason score, T-stage) Overall survival (OS) Predictors for OS (PSM, DÁmico risk group, Gleason score, T-stage) MRI predictors for PSM, PSA recurrence and OS
Erectile function (IEEF-5) and urinary continence (IPSS-10) Urinary incontinence rates (≥1daily pads)
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 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
- •Prostate cancer scheduled for prostatectomy. All participated in the previous RCT
排除标准
- •Patients who did not sign the consent paper for any reason or did not accept the study premises.
- •Patients who underwent MRI prior to randomization. Patents who withdrew their consent for any reason during the study.
结局指标
主要结局
Disease-free survival (DFS)
时间窗: 12-years after surgery
The difference between patients randomized to MRI or no-MRI
次要结局
- Overall survival (OS)(12-years after surgery)
- The impact of MRI variables for predicting PSM, PSA recurrence and OS(After 12 years)
- The impact of the length of positive surgical margin and Gleason score upon DFS.(After 12 years)
- Erectile dysfunction(After 12 years)
研究者
Erik Rud
Principal Investigator
Oslo University Hospital