A Randomized Control Trial of Magnetic Resonance Imaging-targeted Biopsy Compared to Standard Trans-rectal Ultrasound Guided Biopsy for the Diagnosis of Prostate Cancer in Men Without Prior Biopsy
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 500
- 试验地点
- 1
- 主要终点
- Proportion of men with clinically significant detected
研究概览
简要总结
This evaluates the detection rates of prostate cancer by MRI-targeted prostate biopsy compared to standard 12-core trans-rectal ultrasound guided (TRUS) prostate biopsy. Each participant will be randomly allocated to one of the biopsy tests.
We hypothesise that MRI-targeted biopsy will detect no fewer clinically significant cancers than TRUS biopsy but will detect fewer clinically insignificant prostate cancers than TRUS biopsy.
详细描述
The classical pathway for the diagnosis of prostate cancer is trans-rectal ultrasound guided (TRUS) biopsy of the prostate following a raised PSA. This is currently the mainstay for prostate cancer diagnosis in the majority of centres. It has many advantages and can be performed routinely under local anaesthetic in an outpatient setting. However it does have some limitations, including the over-diagnosis of insignificant cancer and the under-diagnosis of significant cancer.
An alternative pathway for the diagnosis of prostate cancer in men with raised prostate specific antigen (PSA) is to perform a multi-parametric MRI to localize cancer and to use this information to influence conduct of a subsequent biopsy, known as an MRI-targeted biopsy. MRI-targeted biopsy has been shown in preliminary studies to detect a similar amount of clinically significant cancer to TRUS-biopsy but may have several advantages, for example in reducing the number of men who require biopsy.
This randomized controlled trial aims to assess the detection rate of clinically significant and clinically insignificant cancer of MRI-targeted biopsy compared to standard 12-core TRUS biopsy in men referred with clinical suspicion of prostate cancer who have had no prior prostate biopsy.
A 'clinically insignificant cancer' is cancer which is unlikely to progress or affect a man's life expectancy and therefore does not warrant treatment. However when diagnosed with insignificant cancer a large proportion of patients request treatment in case a more significant cancer is present. A prostate cancer detection pathway that finds significant cancers while avoiding the diagnosis of insignificant cancer is a major unmet need.
The potential implications of this trial include:
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
- Single (Outcomes Assessor)
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 who have been advised to have a prostate biopsy
- •Serum PSA ≤ 20ng/ml within the previous 3 months
- •Suspected stage ≤ T2 on rectal examination (organ-confined prostate cancer) within the previous 3 months
- •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
- •Contraindication to MRI (e.g. claustrophobia, pacemaker, estimated glomerular filtration rate ≤ 50mls/min)
- •Contraindication to prostate biopsy
- •Men in whom artifact would reduce the quality of the MRI
- •Previous hip replacement surgery, metallic hip replacement or extensive pelvic orthopaedic metal work
- •Unfit to undergo any procedures listed in protocol
研究组 & 干预措施
MRI-arm
Men in this arm will undergo multi-parametric MRI. In the presence of a suspicious area, a man will undergo MRI-targeted biopsy with cores targeted to the suspicious lesion. In the absence of a suspicious area, no biopsy will be taken.
干预措施: MRI (Device)
MRI-arm
Men in this arm will undergo multi-parametric MRI. In the presence of a suspicious area, a man will undergo MRI-targeted biopsy with cores targeted to the suspicious lesion. In the absence of a suspicious area, no biopsy will be taken.
干预措施: MRI-targeted biopsy (Procedure)
TRUS-biopsy arm
Men in this arm undergo standard 12-core trans-rectal ultrasound guided prostate biopsy
干预措施: TRUS-biopsy (Procedure)
结局指标
主要结局
Proportion of men with clinically significant detected
时间窗: When histology results available, at an expected average of 30 days post-biopsy
次要结局
- Proportion of men who go on to definitive treatment for prostate cancer(After treatment decision, at an expected average of 30 days post-biopsy)
- Proportion of men with post-biopsy adverse events(30 days post biopsy)
- Proportion of men with MRI score 3, 4 or 5 who have no clinically significant cancer detected(When histology results available, at an expected average of 30 days post-biopsy)
- Proportion of men in MRI arm who avoid biopsy(When MRI results available, at an expected average of 30 days post-MRI)
- Proportion of men undergoing Radical prostatectomy who have Gleason grade upgrading(An expected average of 90 days post-biopsy)
- Proportion of men with clinically insignificant detected(When histology results available, at an expected average of 30 days post-biopsy)
- EQ-5D-5L Quality of Life scores(Baseline, 24 hours post intervention and 30 days post intervention)
- Cost per diagnosis of cancer(30 days post-biopy)
- Cancer core length of the most involved biopsy core (maximum cancer core length)(When histology results available, at an expected average of 30 days post-biopsy)
研究者
Veeru Kasivisvanathan
Study Coordinator
University College, London