Key messages
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Screening for prostate cancer using a blood test likely reduces the risk of dying from prostate cancer and may also reduce the risk of dying from any cause. Screening likely makes little to no difference in the diagnosis of advanced prostate cancer but may reduce the diagnosis of metastatic prostate cancer (cancer that has spread to other body parts).
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Screening likely increases the number of men diagnosed with any prostate cancer, as well as early-stage cancer, placing some at risk of being diagnosed and treated for cancers that may not matter during their lifetime.
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A newer screening approach that combines the standard blood test with a wider set of blood test markers and prostate imaging likely finds more prostate cancers, but whether it reduces deaths from prostate cancer or any cause is unclear.
What is prostate cancer screening?
Prostate cancer develops in the prostate, a small gland below the bladder that makes fluid for semen. It is one of the most common types of cancer in men, mainly affecting men aged over 50. If caught early, it can usually be treated successfully. Screening tests are designed to diagnose prostate cancer in the early stages where there may be no symptoms or before slow-growing cancers cause problems.
The ‘PSA’ (prostate-specific antigen) blood test looks for high PSA levels in the blood, which can indicate prostate cancer. The next step for men with high PSA is a biopsy, where a small tissue sample is removed and tested for cancer. Treatments such as surgery or radiation are then given. But these treatments may cause unwanted effects, such as leaking urine or having to urinate too often, difficulties with erections, and bowel problems.
What did we want to find out?
We aimed to find out if screening for prostate cancer using PSA in men without any cancer symptoms reduces their risk of dying from prostate cancer or other causes. We also wanted to find out if PSA testing:
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causes any harm;
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affects men's quality of life; and
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has any impact on how often prostate cancer is diagnosed, and whether diagnoses occur when cancer is localised (only in the prostate gland), advanced (grown beyond the prostate gland), or has spread to other parts of the body (metastasised).
What did we do?
We searched for studies that compared PSA screening to no screening in men with no cancer symptoms. We compared and summarised the results of the studies and rated our confidence in the evidence, based on factors such as study methods and numbers of men included.
What did we find?
We found six studies involving 789,086 men, most of whom were White. The studies were conducted in Canada, Europe, and the USA. The men were between 45 and 80 years old and were followed for 3.2 to 23 years.
Main results
PSA testing:
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likely reduces the risk of dying from prostate cancer over 23 years of follow-up: 2 fewer men die of prostate cancer per 1000 men screened (evidence from 1 study with 162,241 men);
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may reduce the risk of dying from any cause: 5 fewer men die of prostate cancer per 1000 screened (4 studies, 675,121 men);
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may make little to no difference to the number of men who experience serious harmful, unwanted events, defined as deaths from biopsy or prostate cancer treatment (1 study, 408,721 men);
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may result in little to no difference in men's quality of life (1 study, 969 men).
For prostate cancer diagnoses, evidence from 1 trial with 162,236 men shows that PSA testing:
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likely increases the numbers of men diagnosed with any prostate and localised prostate cancer: 36 more men are diagnosed with any prostate cancer and 34 more men with localised cancer per 1000 men screened;
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likely makes little to no difference to advanced prostate cancer diagnoses;
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may reduce the number diagnosed with metastatic cancer: 5 fewer men per 1000 screened.
We did not find evidence on other unwanted effects of screening, including problems related to biopsies (e.g. serious infections or hospital admissions) or treatments (e.g. urinary problems, erection difficulties, bowel problems).
One study, involving 60,745 men, examined a combination of the standard blood test plus a wider set of blood tests and prostate imaging. This approach likely has little to no effect on the number of men diagnosed with prostate cancer, including both early and advanced stages. This study did not report whether testing affected the number of deaths.
What are the limitations of the evidence?
We are moderately confident in the evidence from one large, well-conducted, long-running study. We have lower confidence in the evidence from the other five studies due to concerns about how they were conducted and differences in their results.
This review provides little information about the unwanted effects of screening because the studies we considered do not typically collect this information, especially delayed or infrequent unwanted effects.
How up to date is this evidence?
This updates our previous review published in 2013. The evidence is current to 19 November 2025.
阅读完整摘要
Any form of screening aims to reduce disease-specific and overall mortality, and to improve a person's future quality of life. Screening for prostate cancer has generated considerable debate within the medical and broader community, as demonstrated by the varying recommendations made by medical organizations and governed by national policies. To better inform individual patient decision-making and health policy decisions, we need to consider the entire body of data from randomised controlled trials (RCTs) on prostate cancer screening summarised in a systematic review. In 2006, our Cochrane review identified insufficient evidence to either support or refute the use of routine mass, selective, or opportunistic screening for prostate cancer. An update of the review in 2010 included three additional trials. Meta-analysis of the five studies included in the 2010 review concluded that screening did not significantly reduce prostate cancer-specific mortality. In the past two years, several updates to studies included in the 2010 review have been published thereby providing the rationale for this update of the 2010 systematic review.
研究目的
To assess the effects of prostate cancer screening compared to no screening in men with no prior diagnosis of prostate cancer.
检索策略
We searched the Cochrane Library, MEDLINE, Embase, five other databases, and two trial registers from their inception to November 2025. We did not apply language restrictions.
纳入排除标准
All RCTs of screening versus no screening for prostate cancer were eligible for inclusion in this review.
资料收集与分析
The original search (2006) identified 99 potentially relevant articles that were selected for full-text review. From these citations, two RCTs were identified as meeting the inclusion criteria. The search for the 2010 version of the review identified a further 106 potentially relevant articles, from which three new RCTs were included in the review. A total of 31 articles were retrieved for full-text examination based on the updated search in 2012. Updated data on three studies were included in this review. Data from the trials were independently extracted by two authors.
主要结果
Five RCTs with a total of 341,342 participants were included in this review. All involved prostate-specific antigen (PSA) testing, with or without digital rectal examination (DRE), though the interval and threshold for further evaluation varied across trials. The age of participants ranged from 45 to 80 years and duration of follow-up from 7 to 20 years. Our meta-analysis of the five included studies indicated no statistically significant difference in prostate cancer-specific mortality between men randomised to the screening and control groups (risk ratio (RR) 1.00, 95% confidence interval (CI) 0.86 to 1.17). The methodological quality of three of the studies was assessed as posing a high risk of bias. The European Randomized Study of Screening for Prostate Cancer (ERSPC) and the US Prostate, Lung, Colorectal and Ovarian (PLCO) Cancer Screening Trial were assessed as posing a low risk of bias, but provided contradicting results. The ERSPC study reported a significant reduction in prostate cancer-specific mortality (RR 0.84, 95% CI 0.73 to 0.95), whilst the PLCO study concluded no significant benefit (RR 1.15, 95% CI 0.86 to 1.54). The ERSPC was the only study of the five included in this review that reported a significant reduction in prostate cancer-specific mortality, in a pre-specified subgroup of men aged 55 to 69 years of age. Sensitivity analysis for overall risk of bias indicated no significant difference in prostate cancer-specific mortality when referring to the meta analysis of only the ERSPC and PLCO trial data (RR 0.96, 95% CI 0.70 to 1.30). Subgroup analyses indicated that prostate cancer-specific mortality was not affected by the age at which participants were screened. Meta-analysis of four studies investigating all-cause mortality did not determine any significant differences between men randomised to screening or control (RR 1.00, 95% CI 0.96 to 1.03). A diagnosis of prostate cancer was significantly greater in men randomised to screening compared to those randomised to control (RR 1.30, 95% CI 1.02 to 1.65). Localised prostate cancer was more commonly diagnosed in men randomised to screening (RR 1.79, 95% CI 1.19 to 2.70), whilst the proportion of men diagnosed with advanced prostate cancer was significantly lower in the screening group compared to the men serving as controls (RR 0.80, 95% CI 0.73 to 0.87). Screening resulted in a range of harms that can be considered minor to major in severity and duration. Common minor harms from screening include bleeding, bruising and short-term anxiety. Common major harms include overdiagnosis and overtreatment, including infection, blood loss requiring transfusion, pneumonia, erectile dysfunction, and incontinence. Harms of screening included false-positive results for the PSA test and overdiagnosis (up to 50% in the ERSPC study). Adverse events associated with transrectal ultrasound (TRUS)-guided biopsies included infection, bleeding and pain. No deaths were attributed to any biopsy procedure. None of the studies provided detailed assessment of the effect of screening on quality of life or provided a comprehensive assessment of resource utilization associated with screening (although preliminary analyses were reported).
作者结论
Screening likely reduces prostate cancer-specific mortality and may reduce overall mortality. It may have little to no effect on adverse events (as measured by intervention-related mortality). Study limitations, inconsistency, and imprecision reduced our confidence in the effect estimates. Interpretation of these findings is highly sensitive to the choice of MCID. We found insufficient evidence on the potential harms of screening, such as biopsy- and treatment-related complications. Emerging alternatives, such as screening with a kallikrein panel and MRI, may have little to no effect on diagnoses of prostate cancer, but the results on mortality are not yet known.
资助
This Cochrane review had no dedicated funding.
注册
Protocol (2004) DOI: 10.1002/14651858.CD004720
Original review (2006) DOI: 10.1002/14651858.CD004720.pub2
Review update (2013) DOI: 10.1002/14651858.CD004720.pub3
