A Study Comparing Bi-parametric MRI to Multi-parametric MRI in the Diagnosis of Clinically Significant Prostate Cancer
试验速览
- 阶段
- 不适用
- 入组人数
- 500
- 试验地点
- 35
- 主要终点
- Proportion of men with clinically significant cancer
研究概览
简要总结
This prospective clinical trial (PRostate Imaging using Mri +/- contrast Enhancement (PRIME)) aims to assess whether biparametric MRI (bpMRI) is non-inferior to multiparametric mpMRI (mpMRI) in the detection of clinically significant prostate cancer.
This means that we are comparing MRI scans that requires injection of IV contrast (the current standard practice) versus MRI scans that can be performed without IV contrast in the detection of prostate cancer.
详细描述
The PRECISION study (NCT02380027) has established that multiparametric MRI +/- targeted biopsy of suspicious areas identified on MRI is superior to standard 12 core TRUS biopsy in the detection of clinically significant prostate cancer (Gleason > 3+ 4) (38% vs 26%), in reducing the detection of clinically insignificant prostate cancer (Gleason 3 + 3) (9% vs 22%) and in maximising the proportion of cores positive for prostate cancer (44% vs 19%).
Multiparametric MRI (mpMRI) typically uses T2-weighted (T2W), diffusion-weighted (DWI) and dynamic contrast enhanced (DCE) sequences. As a mpMRI is a precious resource, due to capacity and resource limitations, one of the major challenges across institutions is delivering a health service with pre-biopsy MRI before a biopsy in all men with suspected prostate cancer.
However, biparametric MRI (bpMRI), that is, a combination of T2W and DWI, which does not use the DCE sequences, has demonstrated similar detection rates of prostate cancer as mpMRI in some studies and there is a debate about the necessity of the DCE sequence.
The potential advantages of avoiding the DCE sequence include avoiding the cost associated with it, shorter scan time, avoiding the need for medical practitioner attendance, and avoiding putative basal ganglia accumulation and the possibility of adverse neurological effect. Thus, a bpMRI approach may be more feasible and have health-economic benefits over a mpMRI approach and may thus increase the accessibility of this resource to men who need it.
PRIME is a multi-centre study. Men referred with clinical suspicion of prostate cancer based on raised prostate specific antigen (PSA) or abnormal digital rectal examination (DRE) who have had no prior biopsy undergo mpMRI. The DCE sequence is blinded from the radiologist who reports the bpMRI first. After reporting the bpMRI, the DCE sequence is made available to the radiologist who reports the mpMRI. The MRIs and lesions are scored on 1-5 scales of suspicion for the likelihood that clinically significant cancer is present:
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- Single (Care Provider)
盲法说明
Radiologist assessing MRI for suspicion of prostate cancer is blinded to the contrast sequence when reporting the biparametric MRI. After this report, they are unblinded to the contrast sequence and report the multiparametric MRI. All biopsies conducted as a result of MRI findings will be labelled as bpMRI and mpMRI, and diagnostic accuracy will be assessed against histology findings.
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
- •Men at least 18 years of age referred with clinical suspicion of prostate cancer
- •Serum PSA ≤ 20ng/ml
- •Fit to undergo all procedures listed in protocol
- •Able to provide written informed consent
排除标准
- •Prior prostate biopsy
- •Prior treatment for prostate cancer
- •Prior prostate MRI on a previous encounter
- •Contraindication to MRI
- •Contraindication to prostate biopsy
- •Unfit to undergo any procedures listed in protocol
结局指标
主要结局
Proportion of men with clinically significant cancer
时间窗: When biopsy results available, at an expected average of 30 days post-biopsy
次要结局
- Agreement between bpMRI and mpMRI for radiological staging decision(When MRI results available, at an expected average of 30 days post-MRI)
- Cost-effectiveness of BpMRI compared to mpMRI (cost per diagnosis of prostate cancer)(At an expected average of 30 days post-intervention)
- Agreement between bpMRI and mpMRI for score of suspicion(When MRI results available, at an expected average of 30 days post-MRI)
- Test performance characteristics for bpMRI & mpMRI when using the Likert scoring system in comparison to the PIRADS scoring system(When biopsy results available, at an expected average of 30 days post-MRI)
- Proportion of men with clinically insignificant cancer (Gleason grade 3+3 / Gleason grade group 1)(When biopsy results available, at an expected average of 30 days post-biopsy)
- Agreement between bpMRI and mpMRI for treatment eligibility(When treatment options discussed in multidisciplinary meeting, at an expected average of 30 days post intervention)
- Proportion of men with cancer missed by bpMRI and mpMRI-targeted biopsies and detected by systematic biopsy(When biopsy results available, at an expected average of 30 days post-biopsy)