A Randomized Clinical Trial Comparing the Efficacy of MRI Versus PSA for Prostate Cancer Screening: The MVP Study (MRI vs PSA)
试验速览
- 阶段
- 不适用
- 入组人数
- 1,010
- 试验地点
- 2
- 主要终点
- Clinically-significant prostate cancer
研究概览
简要总结
In this open randomized controlled trial, we seek to study whether prostate cancer screening using multiparametric prostate magnetic resonance imaging (mpMRI) improves the detection rate of clinically-significant prostate cancer (defined as Gleason score ≥7 on prostate biopsy) compared with prostate cancer screening using prostate-specific antigen (PSA).
The current paradigm of prostate cancer screening relies upon an initial PSA blood test, with subsequent investigations driven by the serum PSA level. This model has proven highly controversial due to the inability of PSA level to discern between indolent and aggressive forms of prostate cancer. As a result, numerous government-sponsored bodies have recommended against PSA screening. Evidence suggests that prostate cancer screening has led to an increased proportion of men being diagnosed with potentially curable prostate cancer. However, due to the inability of the PSA level to accurately distinguish patients with indolent and lethal forms of prostate cancer, it has led to a significant rate of over-diagnosis of indolent disease. Magnetic resonance imaging has been gaining an increasingly large role in the management of patients with clinically-localized prostate cancer including diagnosis in patients with abnormal PSA levels, monitoring of patients on active surveillance and staging prior to definitive interventions. MRI-based prostate cancer risk assessment has been shown to better distinguish between clinically-significant and insignificant tumors than PSA test. Therefore, a randomized controlled trial of MRI-based prostate cancer screening and PSA-based prostate cancer screening is warranted.
详细描述
BACKGROUND AND RATONALE:
Prostate cancer is the most common non-cutaneous malignancy and the third leading cause of cancer death among men in Canada1. In 1987, prostate specific antigen was introduced for prostate cancer screening2. Widespread adoption of PSA screening resulted in a significantly increased number of incident cases and a significantly reduced number of cases of metastatic disease at presentation3. Coinciding with the introduction of PSA testing, prostate cancer mortality has decreased approximately 40% from an epidemiologic perspective4. Approximately 45-70% of the decline in mortality is attributable to PSA-based prostate cancer screening5. Several studies have examined whether screening for prostate cancer using the PSA test improves overall and prostate cancer mortality. In particular, two large randomized studies in the U.S. and Europe have been conducted to evaluate this. Recently, the U.S. Preventative Services Task Force (USPSTF) reviewed these and all studies to evaluate whether PSA should be used as a screening test.
Current Recommendations for PSA Screening from the USPSTF
The USPSTF makes recommendations regarding the effectiveness of screening tests for asymptomatic patients after assessing the evidence regarding benefits and harms of an intervention. The most recent USPSTF guidelines regarding prostate cancer were published in 20126.
The first component of the USPSTF assessment is an evaluation of the benefits of early detection and treatment of prostate cancer. The review panel drew on two large randomized controlled trials which have been conducted to assess the effect of PSA-based prostate cancer screening on prostate cancer mortality: the European Randomized Study of Screening for Prostate Cancer (ERSPC)7 and the U.S.-based Prostate, Lung, Colorectal and Ovarian (PLCO) Cancer Screening Trial8. In their recommendation the guideline panel do not consider significant differences between the trials, in large part due to the fact that PSA had been widely adopted in the US during the study interval while it did not have such uptake in Europe. As a result, there are concerns that the trial did not compare screening to no screening and that the trial would be unlikely to find a benefit even if a significant one existed9. Regardless, the panel concluded that prostate cancer screening resulted in the avoidance of 0 to 1 prostate cancer deaths per 1000 men screened6, a minimal benefit.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Screening
- 盲法
- None
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •age greater than or equal to 50 years old
- •life expectancy greater than or equal to 10 years, according to the clinical judgement of study investigators
排除标准
- •history of previous prostate biopsy
- •PSA level measurement within 3 years of recruitment date
- •abnormal digital rectal examination of the prostate consistent with prostate cancer
- •history of prostate cancer in one or more first-degree relatives diagnosed at less than 50 years of age
- •lower urinary tract voiding symptoms (IPSS greater than or equal to 8)
- •prior or current use of 5-alpha reductase inhibitor medications (finasteride or dutasteride)
- •patient unable to communicate in English in order to give proper informed consent
- •claustrophobia or other medical indication which would preclude MRI
- •any medical condition which, in the opinion of the investigator, might interfere with the evaluation of the study objectives
研究组 & 干预措施
Multi-parametric MRI
Patients from the general population without history of previous prostate biopsy will be allocated to receive mpMRI in order to evaluate for risk of prostate cancer.
干预措施: Multi-parametric MRI (Device)
PSA Only
Patients from the general population without history of previous prostate biopsy will be allocated to receive serum PSA testing in order to evaluate for risk of prostate cancer.
Patients with a serum PSA level less than 4.0 ng/mL will be managed expectantly with results provided to their primary care physician.
干预措施: PSA testing (Other)
结局指标
主要结局
Clinically-significant prostate cancer
时间窗: Within 3 years of randomization
Gleason score greater than or equal to 7 on TRUS prostate biopsy
次要结局
- Clinically-insignificant prostate cancer(Within 3 years of randomizations)
研究者
Dr. Robert Nam
Professor of Surgery
Sunnybrook Health Sciences Centre