A Randomised Controlled Trial of Regular MRI Scans Compared to Standard Care in Patients With Prostate Cancer Managed Using Active Surveillance
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 1,263
- 试验地点
- 15
- 主要终点
- Biopsy
研究概览
简要总结
The goal of this intervention study is for patients on active surveillance for prostate cancer, to demonstrate that use of regular MRI scans is better able to detect cancer progression over 5 years compared to the current NICE defined strategy.
Research Question P - In patients who are on active surveillance for low to medium risk prostate cancer, I - is the use of regular MRI scans C - compared to current NICE defined standard of care, O - better at detecting cancer progression with less cost to the NHS (fewer PSA tests, biopsies and clinic visits)?
Patients will be allocated in a 1.1 ratio to either MRI scans or the current NICE defined standard. Randomisation will be blocked (random block size) and stratified by MRI visibility of lesions (3 categories [ no visible lesion, diffuse changes, discrete visible lesion]), cancer Grade Group (GG1, GG2) and time since diagnosis. This study will not be blinded to patients or physicians.
详细描述
What is the problem being addressed?
Of 50,000 newly diagnosed patients with prostate cancer every year, about 7,600 choose active surveillance rather than immediate surgery or radiotherapy. Most have low risk whilst 20-30% have medium risk prostate cancer. This is because low and medium risk prostate cancers grow slowly. As a result, immediate treatment does not improve cancer-specific survival over 10 years but can cause high rates of urinary, sexual and bowel side-effects.
Although these cancers are slow growing, 25-34% will progress to higher risk over 5 years and need treatment later. Whilst there is no evidence that delayed detection of progression has an impact on survival, a recent systematic review has shown detrimental effects on other aspects of cancer control. For instance, in the largest RCT comparing active surveillance to immediate surgery or radiotherapy, 2-3 times as many patients had disease progression and cancer spread to other parts of the body in the active surveillance arm. So, active surveillance needs to be improved. NICE currently advise that active surveillance should involve 3-6 monthly prostate specific antigen (PSA) blood tests and rectal examinations. They advise an MRI and biopsy at 12 months. After one year, 3-6 monthly PSA and rectal examinations are recommended and further biopsy if the PSA starts to rise or if the rectal exam detects a prostate nodule.
This is problematic for 3 reasons:
First, PSA and rectal examination changes are inaccurate in detecting progression. As a result, some centres do regular biopsies every 1-2 years; this is borne out by a 48 physician survey (Jan 2022). However, biopsies alone are also inaccurate as they are ultrasound-guided; the operator can see the prostate but not areas suspicious for cancer progression.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Other
- 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
- •Age 18 years or above (no upper limit)
- •Patients with a prostate (either cis-male gender or trans-female gender with no prior androgen deprivation hormone use at all).
- •Diagnostic bi-parametric or multiparametric MRI
- •Diagnostic systematic biopsy +/- targeted biopsy
- •A histological diagnosis of localised prostate cancer
- •Patient chosen active surveillance
排除标准
- •On active surveillance for greater than 9 months prior to screening date.
- •Contraindication to MRI or gadolinium contrast
- •Previous hip replacement to both hips
- •Contraindication to performing a biopsy guided by a transrectal ultrasound probe
研究组 & 干预措施
Standard care (Control) Arm
PSA 3 monthly in year 1 and then 6 monthly with rectal exam annually if clinically indicated. MRI will be carried out at 12 months (if not had one at diagnosis). If a diagnostic MRI was carried out, a 12 month MRI scan will not be required. A biopsy will be required if indicated due to changes in rectal exam or PSA. Follow-up for 5 years.
Intervention Arm
Patients with a visible lesion or medium risk cancer will have PSA 6 monthly and MRI scans annually. As per international PIRADS committee guidance the surveillance MRIs will be biparametric MRI scans which last approximately 15 minutes and exclude gadolinium contrast injection. All other patients will undergo PSA 6 monthly and MRI in years 1, 3 and 5. In all patients, a targeted biopsy will be carried out if the MRI PRECISE score is >/=4.
干预措施: MRI Scans (Diagnostic Test)
结局指标
主要结局
Biopsy
时间窗: 5 Years
Progression in each group defined as higher risk cancer on biopsy (Grade Group \>/=3) Prostate cancer progression rates and time to progression in each randomised arm defined on, • biopsy: grade progression to Grade Group 3 or greater or detection on biopsy of intraductal cancer or lymphovascular invasion. Many of our clinicians would include patients on active surveillance with cribriform pattern on Grade Group so this is not a factor for progression.
Staging
时间窗: 5 Years
Progression in each group defined as higher risk cancer on higher stage (\>/=T3 or \>/=N or \>/=M1) over 5 years. Prostate cancer progression rates and time to progression in each randomised arm defined on, • staging: cancer has spread to surrounding tissues (extracapsular), lymph node involvement or distant body parts as demonstrated on cross-sectional imaging including MRI, CT, bone-scan or PET scans as deemed appropriate by the local multidisciplinary cancer team.
次要结局
- Cost-effectiveness(5 Years)
- Compliance(5 Years)
- HADS Questionnaires(5 Years)
- Treatment(5 Years)
- MRI & biopsy-related adverse events(5 Years)
- Biopsy Measurement(5 years)
- EPIC Questionnaires(5 years)
- EQ-5D-5L Questionnaires(5 years)