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Project Title:
Assessing the Case for Introducing a National Prostate Cancer Screening Program Using the Prostate-Specific Antigen (PSA) Test.
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Project Report help for Imperial College London
SCREENING
APPLYING THE WILSON AND JUNGNER CRITERIA TO PROSTATE CANCER
| Criteria | Arguments for | Arguments against |
| THE DISEASE | ||
| Important public health problem | Prostate cancer is the most commonly diagnosed cancer among men in Canada. This suggests it is a common disease.Prostate cancer is the third leading cause of cancer deaths among Canadian men. This indicates it can be a serious disease.The lifetime risk of being diagnosed with prostate cancer in Canada is 14.3%, and the lifetime risk of dying from it is 3.6%. This shows it impacts a significant proportion of men. | The 5-year net survival rate for prostate cancer in Canada is high at 95%. This suggests that even though common, it may not always be that serious.Early stage prostate cancers have almost 100% 5-year survival. It is mainly late stage prostate cancers that have poor survival. Screening aims to detect early stage disease.Autopsy studies show a high prevalence of undiagnosed prostate cancer that does not cause symptoms or death. This indicates overdiagnosis could be an issue with screening. |
| Natural history, including development from latent to declared disease, is adequately understood. | The progression of prostate cancer from latent to symptomatic disease is relatively well characterized. Prostate cancer usually develops slowly and may remain asymptomatic for years.There is a recognized preclinical phase detectable by elevated PSA levels before symptoms occur. The PSA test can identify this preclinical state. | Our understanding of why some prostate cancers remain latent while others progress rapidly is limited. The natural history across patients is heterogeneous.Factors that determine which preclinical cases will progress to advanced disease vs remain indolent are not well elucidated. This makes it hard to determine who will benefit from early detection.The causes of prostate cancer development are largely unknown. This gap in etiology understanding undermines our knowledge of natural history.In summary, while the broad natural history of prostate cancer is characterized, the heterogeneity across patients and inability to predict disease course makes this only partially met. Key gaps remain in understanding etiology and defining the preclinical phase that will benefit from early detection. |
| Recognizable latent or early symptomatic stage. | There is a preclinical phase where PSA is elevated but no symptoms are present. This provides a window for early detection by screening.Screening studies like ERSPC have demonstrated many asymptomatic cancers can be identified by PSA testing. This indicates a sizable latent period exists.Common early symptoms like urinary frequency/urgency and hematuria can indicate early stage prostate cancer. This provides some early symptom recognition. | There is no clear way to determine which preclinical cases detected will progress to advanced disease. The predictive value of the latent stage is limited.The early symptoms of prostate cancer are non-specific and have many other potential causes besides cancer. This makes early symptomatic recognition difficult.The latent asymptomatic period where PSA is elevated but no symptoms are present varies widely across patients from months to decades. The length of this phase is heterogeneous. |
| THE SCREENING TEST | ||
| Suitable test or examination available that is safe, valid, simple, cheap and reliable | The PSA test is simple, requiring only a blood sample. It is relatively inexpensive and can be easily administered.PSA testing is considered safe with few major harms. Pain and complications from biopsies prompted by positive tests are the main downsides.The PSA test has reasonable accuracy for indicating prostate cancer risk. At standard cutoffs it has both fair sensitivity and specificity. | No PSA threshold completely excludes prostate cancer risk. There is no clear optimal cutoff that balances sensitivity and specificity.PSA levels can be elevated for reasons besides cancer, like benign prostate enlargement or inflammation leading to false positives. PSA is not cancer specific.PSA testing prompts further invasive diagnostic procedures like biopsy with associated harms in those without cancer. |
| Test is acceptable to the population | The PSA test is a simple blood draw that is minimally invasive. This makes it more acceptable than more invasive screening procedures.There is generally high public awareness of and concern about prostate cancer risk among older men. This predisposes men to want testing.Some professional groups and prostate cancer advocacy organizations strongly promote PSA testing. This shapes social norms and acceptability. | The PSA test has a high false positive rate, leading many men without cancer to undergo painful prostate biopsies and anxiety. This harms acceptability.Frequent testing is required, reducing acceptance due to burden and inconvenience for men.There are concerns about overdiagnosis and overtreatment, making some men hesitant to get tested. |
| DIAGNOSTIC TEST AND TREATMENT | ||
| An agreed policy on whom to treat as patients. | There are established guidelines on risk-based treatment recommendations based on biopsy results and cancer stage after a positive PSA screen. This provides some policy basis.Active surveillance protocols exist for monitoring and deferring treatment in lower risk cases detected by screening until progression is confirmed. This avoids overtreatment. | There is no consensus guideline on the PSA threshold that should trigger a biopsy referral after a positive screen. Different cutoffs are used.Whether to prioritize treatment of screen detected localized cancers vs asymptomatic advanced cancers is debated, given risks like overdiagnosis.Optimal treatment choices even for confirmed cancer post-screening is variable, with debates around options like surgery vs radiation. |
| An accepted treatment for patients with recognized disease. | Several effective treatment options exist for prostate cancer including radical prostatectomy, radiation therapy, and hormone therapy.These available treatments have demonstrated ability to reduce morbidity and mortality from prostate cancer.Treatment is generally well tolerated and improves outcomes relative to no treatment. | All major treatments for prostate cancer carry risks of side effects like impotence and incontinence that affect quality of life.Determining the balance between treating screen detected cancers early vs delayed treatment is debated due to overdiagnosis and overtreatment concerns.There is variability in treatment effectiveness and side effects based on patient age, cancer stage, and comorbidities. No single accepted approach. |
| Facilities for diagnosis and treatment should be available. | Canada has widespread access to PSA testing facilities and labs able to handle the volume of screening tests.Resources for diagnostic tests like biopsy are available within the Canadian healthcare system.Treatment facilities and specialists for managing identified prostate cancers are present, at least in larger urban centers. | Rural and remote regions may lack local access to biopsy and other diagnostic facilities to evaluate positive screens.Long wait times for biopsy and specialist treatment already exist in many areas. PSA screening could overwhelm resources.Budgets allocated to diagnostic and treatment services may be insufficient to handle increased case finding from screening without detracting from other priorities. |
| OVERALL SCREENING PROGRAMME | ||
| Cost of case-finding (including diagnosis and treatment of patients diagnosed) should be economically balanced in relation to possible expenditure on medical care as a whole. | Economic modeling studies based on clinical trial data have found PSA screening starting at age 50 and conducted every 2 years may be cost-effective.Screening from age 50-59 was estimated to have an incremental cost-effectiveness ratio below the commonly used $100,000 per QALY (Quality Adjusted Life Year) threshold.Screening enables early treatment of prostate cancer which can reduce costs of managing advanced disease. | Any economic analyses are based on modeling with uncertain assumptions and may not represent real-world costs.Excess costs due to overdiagnosis and overtreatment as well as costs of managing treatment complications have to be considered.Additional infrastructure/staffing costs needed to conduct screening and manage increased diagnoses are often neglected.Opportunity costs relative to other healthcare investments are not usually considered in screening economic analyses. |
| Case-finding should be a continuing process and not a “once and for all” project. | Guideline bodies that recommend PSA screening endorse regular screening at 1–4-year intervals rather than one-time screening. This implies an ongoing screening process.Prostate cancer risk and PSA levels increase with age, so screening older men likely requires repeated testing over time.Screening at one point in time will miss cancers that develop later. Repeated screening enhances case finding. | The benefits of repeated PSA screening in men with initially negative results is questionable based on evidence. Potential harms with additional rounds of screening.It’s unclear what the optimal screening frequency and ages for initiating/ending screening are. Difficult to define parameters of an effective ongoing program.Contamination between study groups compromised assessment of one-time vs repeated screening effects in trials. Hard to evaluate this criterion. |
RECOMMENDATION
We recommend not-screening for prostate cancer with the prostate-specific antigen (PSA) test.
The task force based this recommendation on the overall balance between the possible benefits and harms of PSA screening:
- While prostate cancer is common, the majority of cases detected by PSA screening appear to be indolent disease that will not progress to advanced stages during a man’s lifetime. This risks overdiagnosis and overtreatment with associated harms and costs.
- The PSA test has limited accuracy and specificity for prostate cancer and no clear optimal threshold. This leads to false positive results, unnecessary biopsy complications, and procedure related anxiety in men without cancer.
- Any mortality benefit of PSA screening on a population level is at best very small based on existing evidence from RCTs. This small potential benefit is outweighed by the likelihood of substantive harms and costs to many men.
CONCLUSION:
The Wilson and Jungner criteria for screening are only partially met for PSA testing. The harms seem to outweigh the demonstrated benefits at a population level. We therefore recommend against introducing a national prostate cancer screening program using the PSA test in Canada.
Canada operates three national screening programmes for breast, bowel and cervical cancers. The Department of Health have requested the Canadian Task Force on Preventive Health Care carry out a review as to whether a national prostate cancer screening programme should be introduced.
You are part of the task force and have been asked to draft a report summarising the key considerations for introducing a screening programme with the prostate specific antigen (PSA) test and providing a steer to the Department of Health.
The majority of the report has been written for you however the final steer for the Department of Health needs to be completed.
Contact for Help
Canada operates three national screening programmes for breast, bowel and cervical cancers. The Department of Health have requested the Canadian Task Force on Preventive Health Care carry out a review as to whether a national prostate cancer screening programme should be introduced.
You are part of the task force and have been asked to draft a report summarising the key considerations for introducing a screening programme with the prostate specific antigen (PSA) test and providing a steer to the Department of Health.
The majority of the report has been written for you however the final steer for the Department of Health needs to be completed.
Review the report on PSA screening
Apply the Wilson and Jungner criteria to the proposed PSA screening programme using the table provided in the template.
There is adequate information in the report for you to complete the table. For each criteria there may be arguments for, arguments against, or both arguments for and against.
Use your completed table, to help you provide an overall recommendation to the Department of Health as to whether the programme should be introduced. Justify your recommendation with three arguments.
