Long-term Outcomes of Prostate Cancer Screening Using PSA, Biomarkers and MRI: The STHLM3MRI Trial
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 7,500
- 试验地点
- 1
- 主要终点
- Prostate cancer mortality
研究概览
简要总结
This study is an expansion of the screening-by-invitation STHLM3MRI trial for detection of prostate cancer. In summary, we assess longterm outcomes (prostate cancer mortality, incidence and resource use) in men (i) invited and randomized to a screening program using PSA, a biomarker test and MRI; (ii) invited and randomized to a single PSA test with prostate biopsies followed by opportunistic testing and (iii) population controls. Mortality is verified through register data, disease verification is made through in-study biopsy results and registry data.
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
- Single (Outcomes Assessor)
盲法说明
Outcomes are verified through national registers
入排标准
- 年龄范围
- 50 Years 至 74 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Eligible participants:
- •Men eligible for the longterm f/u-study arms (experimental and control) are participants in the STHLM3MRI trial.
- •Inclusion Criteria:
- •Men age 50-74 years without prior diagnosis of prostate cancer (ICD-9 C61).
- •Permanent postal address in Stockholm
- •Not a previous participant in the Stockholm3 study (2012-2014)
排除标准
- •Severe illnesses such as metastatic cancers, severe cardio-vascular disease or dementia
- •Contraindications for magnetic resonance imaging (MRI) eg pacemaker, magnetic cerebral clips, cochlear implants or severe claustrophobia.
- •Men with a previous prostate biopsy the preceding 60 days before invitation.
研究组 & 干预措施
Organized screening including repeat testing (MRI+biomarkers)
participants are offered prostate cancer screening. Interventions are (i) a paired PSA and Stockholm3 bloodtest; (ii) if elevated (PSA>=3 | Stockholm3>=0.11), an MRI is offered. If MRI shows PI-RADS≥3, prostate biopsies are offered. Screenings are offered at year 0, year 2-3 (if original PSA≥1.5) and year 6
干预措施: PSA/Stockholm3/MRI (Diagnostic Test)
One-time invitation to testing arm (traditional biopsies)
participants are offered prostate cancer screening. interventions are a PSA bloodtest. If PSA≥3 ng/ml, a standard prostate biopsy is offered. No repeat screenings are offered.
干预措施: PSA (Diagnostic Test)
Population controls
Population controls are identified through registers and followed in national outcome registers (Swedish Board of Health and Welfare)
结局指标
主要结局
Prostate cancer mortality
时间窗: 5-10 years
Mortality from prostate cancer (yes/no)
Detection of clinically significant prostate cancer
时间窗: 1-3 years
Gleason Score ≥7 disease detected (Yes/No)
次要结局
- Performed MRI of prostate(1-3 years)
- Prostate cancer metastasis-free survival(5-10 years)
- Detection of prostate cancer by grade(1-3 years)
- Performed prostate biopsy(1-3 years)
- Grading of MRI prostate(1-3 years)
研究者
Tobias Nordström
Associate Professor, Consultant Urologist
Karolinska Institutet