The Effectiveness and Harms of PSA-Based Prostate Cancer Screening: A Systematic Review
Abstract
1. Introduction
2. Methods
2.1. Study Design
2.2. Data Sources and Search Strategy
2.3. Eligibility Criteria
- Studies on adult males, particularly populations of men aged 50 years and older, evaluating the effectiveness or adverse effects of prostate cancer screening.
- Randomized controlled trials (RCTs), cohort studies, meta-analyses, and systematic reviews.
- Studies reporting mortality outcomes, diagnostic accuracy, or risk–benefit evaluations.
- Non-human or cell-based studies.
- Case reports or studies focusing on treatment rather than screening.
- Non-peer-reviewed articles.
2.4. Study Selection and Data Extraction
2.5. Quality Assessment
2.6. Assessment of Heterogeneity
- (1)
- Differences in study population characteristics (e.g., age range, geographic region);
- (2)
- Variation in screening methods (e.g., PSA alone, PSA + MRI, biomarkers);
- (3)
- Outcome definitions (e.g., prostate-cancer-specific mortality, overall mortality);
- (4)
- Duration of follow-up.
2.7. Assessment of Reporting Bias
- -
- Incomplete outcome reporting or the selective reporting of favorable results;
- -
- Asymmetry in the available evidence (e.g., overrepresentation of large trials or certain geographic regions);
- -
- The lack of trial registry information for some RCTs.
2.8. Data Synthesis Approach
3. Results
3.1. Study Selection
3.2. Study Characteristics
3.3. Risk of Bias Assessment Summary
3.4. Effectiveness and Limitations of PSA-Based Screening
3.5. Diagnostic Accuracy of Screening Strategies
3.6. Screening Recommendations by Age and Risk
3.7. Quality of Evidence: GRADE
4. Discussion
4.1. Benefit–Harm Balance and Overdiagnosis
4.2. Role of Community Health Workers (CHWs) in Equitable Screening
4.3. Advances in Precision Screening
4.4. Policy and Practice Implications
4.5. Strengths and Limitations of This Review
4.6. Future Research
5. Conclusions
Supplementary Materials
Author Contributions
Funding
Institutional Review Board Statement
Informed Consent Statement
Data availability statement
Conflicts of Interest
Appendix A. Full Search Strategies for Systematic Review (PRISMA 2020 Compliance)
- Database: PubMed
- Date of final search: 10 January 2025
- (“Prostate Cancer” [MeSH Terms] OR “prostate neoplasms” OR “prostate cancer”) AND (“PSA test” OR “Prostate-Specific Antigen”) AND
- (“Early Detection of Cancer” [MeSH Terms] OR “screening” OR “early diagnosis”) AND (“mortality” OR “death” OR “survival”) AND
- (“Randomized Controlled Trial” [Publication Type] OR “RCT” OR “cohort study” OR “meta- analysis”)
- Limits: English OR Korean language, human studies only
- Database: Embase
- Date of final search: 10 January 2025
- ‘Prostate cancer’/exp OR ‘prostate neoplasm’ OR ‘prostate cancer’ AND
- ‘psa test’ OR ‘prostate specific antigen’ AND
- ‘screening’ OR ‘early diagnosis’/exp AND
- ‘mortality’ OR ‘death’ OR ‘survival’ AND
- ‘randomized controlled trial’/exp OR ‘cohort study’ OR ‘meta-analysis’
- Filters applied: Language (English or Korean), Human studies
- Database: Cochrane Library
- Date of final search: 10 January 2025
- [MeSH descriptor: “Prostatic Neoplasms” explode all trees] AND (“PSA test” OR “Prostate-Specific Antigen”) AND
- [MeSH descriptor: “Early Detection of Cancer”] AND
- (mortality OR death OR survival) AND
- ([MeSH descriptor: “Randomized Controlled Trials as Topic”] OR “RCT” OR “Cohort Study” OR “Meta-Analysis”)
- Limits: English OR Korean, human studies
- Database: KMbase
- Search terms (Korean keywords and English synonyms):
- -
- 전립선암, PSA 검사, 조기진단, 사망률, 생존율, 무작위대조시험, 코호트, 메타분석 등
- -
- Boolean operators: AND/OR 사용, 한국어 논문 포함
- Database: Google Scholar
- Search terms used in Korean and English:
- -
- “Prostate cancer” AND “PSA” AND (“screening” OR “early detection”) AND (“mortality” OR “death”)
- Filters applied: publication year 2014–2024, English/Korean, full text available
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Reference | Year | Setting Country | Study Design | Sample | Key Findings |
---|---|---|---|---|---|
Auvinen A et al. [16] | 2024 | Finland | RCT | 12,750 | ProScreen trial: The evaluation of a multimodal screening protocol incorporating PSA, 4Kscore, and MRI demonstrated the improved detection of clinically significant prostate cancer. |
Fazekas JT et al. [17] | 2024 | Multinational (primarily US) | Meta-analysis | 80,114 | MRI-based screening pathways maintained clinical significance in detecting relevant prostate cancer cases compared to conventional methods. |
Björnebo et al. [18] | 2024 | Sweden | RCT | 12,743 | Biomarkers vs. MRI for prostate cancer screening: This study compared MRI-based and biomarker-based strategies for prostate cancer screening, highlighting their respective diagnostic efficacies. |
Hao S et al. [19] | 2022 | Sweden | Simulation model | - | The Stockholm3 risk prediction model was found to be effective in the repeated screening and stratification of prostate cancer risk. |
Klotz L et al. [20] | 2021 | Canada | RCT | 453 | MRI-targeted biopsy methods demonstrated superior sensitivity compared to traditional TRUS-guided biopsy methods. |
Wei JT et al. [21] | 2023 | USA | Guideline | - | The AUA/SUO Early Detection Guidelines recommend personalized PSA-based screening strategies tailored to patient risk profiles and shared decision-making. |
Bratt O et al. [22] | 2023 | Sweden, Europe | Narrative review | - | This review explored the long-term outcomes of prostate cancer screening and proposed future directions for policy refinement. |
Harten MJ et al. [23] | 2024 | Europe | Narrative review | - | A comprehensive review of prostate cancer screening policies across Europe, focusing on variations in implementation and outcomes. |
US Preventive Services Task Force [24] | 2018 | USA | Guideline | - | USPSTF PSA Screening Guidelines: PSA screening was shown to provide modest mortality benefits, though it was accompanied by risks of overdiagnosis and overtreatment. |
Ilic D et al. [25] | 2018 | Europe, US, etc. | Systematic Review | 721,718 | The systematic review indicated both potential benefits in mortality reduction and harms related to overdiagnosis and false positives. |
Martin RM et al. [26] | 2018 | UK | RCT | 419,582 | PSA Screening and 10-Year Mortality (CAP trial): A single invitation for PSA screening was associated with only a marginal reduction in long-term prostate cancer mortality. |
Hugosson J et al. [27] | 2019 | Europe (8 countries) | RCT | 182,160 | ERSPC 16-Year Follow-Up Europe: The long-term data suggested a reduction in prostate-cancer-specific mortality following systematic PSA-based screening. |
Martin RM et al. [28] | 2024 | UK, US, etc. | Meta-analysis | 721,718 | PSA screening reduced prostate-cancer-specific mortality but had no significant impact on overall mortality rates. |
Vaccarella S et al. [29] | 2024 | Europe (26 countries) | Ecological study (registry data) | - | The study identified notable trends in the overdiagnosis of prostate cancer associated with widespread screening practices. |
Mok Y et al. [30] | 2015 | South Korea | Cohort | 97,274 | Higher PSA levels at screening were associated with increased prostate cancer mortality in Korean men. |
Pinsky P et al. [31] | 2024 | US | Cohort (registry data) | 76,693 | PSA screening reduced disease-specific mortality but was also linked to a high rate of overdiagnosis. |
Screening Tool | Benefits | Risks |
---|---|---|
PSA Test | Accessible, cost-effective | Overdiagnosis, possibility of false positive |
PSA + MRI | High sensitivity, fewer biopsies | High cost, limited MRI access in some regions |
Stockholm3/Biomarkers | Balanced accuracy, risk-stratified | Requires infrastructure, validation |
TRUS biopsy | Widely used, standard method | Lower sensitivity, more complications |
Study [Ref. No.] | Screening Tool | Sensitivity (%) | Specificity (%) |
---|---|---|---|
Klotz L et al. [20] | MRI-Guided Biopsy | 91 | 74 |
Fazekas JT et al. [17] | MRI Screening | 90 | 75 |
Auvinen A et al. [16] | PSA + Biomarker + MRI | 88 | 79 |
Hao S et al. [19] | Stockholm3 | 85 | 81 |
Björnebo et al. [18] | PSA + Biomarker | 83 | 77 |
Pinsky P et al. [31] | PSA Alone | 72 | 60 |
Outcome | Study Design | Risk of Bias | Inconsistency | Indirectness | Imprecision | Publication Bias | Overall Quality | Ref. No |
---|---|---|---|---|---|---|---|---|
Prostate-cancer- specific mortality | RCT/Meta-Analysis | Low | No serious | No serious | No serious | Unlikely | ⬤⬤⬤⬤ High | [27,28] |
All-cause mortality | RCT | Low | Serious | No serious | Serious | Unlikely | ⬤⬤⬤◯ Moderate | [26] |
Overdiagnosis rate | Meta-Analysis/Review | Moderate | Serious | No serious | No serious | Likely | ⬤⬤◯◯ Low | [29] |
Biopsy-related complications | Systematic Review | Low | No serious | Some | Serious | Unclear | ⬤⬤◯◯ Low | [25] |
Diagnostic accuracy (MRI/biomarkers) | RCT/Observational | Low | No serious | No serious | No serious | Unlikely | ⬤⬤⬤⬤ High | [18,20] |
Policy and guideline consistency | Guideline/Review | Low | No serious | No serious | No serious | Unlikely | ⬤⬤⬤◯ Moderate | [21,23] |
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Oh, C.-u.; Kang, H. The Effectiveness and Harms of PSA-Based Prostate Cancer Screening: A Systematic Review. Healthcare 2025, 13, 1381. https://doi.org/10.3390/healthcare13121381
Oh C-u, Kang H. The Effectiveness and Harms of PSA-Based Prostate Cancer Screening: A Systematic Review. Healthcare. 2025; 13(12):1381. https://doi.org/10.3390/healthcare13121381
Chicago/Turabian StyleOh, Chung-uk, and Hyekyung Kang. 2025. "The Effectiveness and Harms of PSA-Based Prostate Cancer Screening: A Systematic Review" Healthcare 13, no. 12: 1381. https://doi.org/10.3390/healthcare13121381
APA StyleOh, C.-u., & Kang, H. (2025). The Effectiveness and Harms of PSA-Based Prostate Cancer Screening: A Systematic Review. Healthcare, 13(12), 1381. https://doi.org/10.3390/healthcare13121381