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Cancer Atlas 2026 · Prostate cancer

Prostate Cancer Biomarkers in 2026: PSA, the Testing Pathway, Assay Standards and Screening Evidence

Prostate cancer is the most often diagnosed cancer in men in 123 of 186 countries. The blood test at the center of early detection, prostate-specific antigen (PSA), is useful but imperfect: it opens a decision pathway and does not diagnose cancer on its own. This article covers the burden, screening evidence and guideline status as of 1 October 2026, the PSA pathway and assay calibration.

By OncoFirm™ Scientific TeamPublished 1 Oct 2026Updated 1 Oct 2026Sources peer-reviewed, guidelines, regulators, linked

At a glance

Burden

About 1.55 million new cases and 420,000 deaths worldwide in 2024; 333,830 new US cases expected in 2026.

Stage and survival

US five-year relative survival: 100.0% for localized and regional disease, 40.1% for distant disease (SEER, 2016–2022).

Screening status

A shared decision, not a population program. USPSTF grade C at ages 55–69 (2018; update pending). UK NSC: BRCA2 carriers only (May 2026).

Key biomarkers

Total PSA is the entry test. PSA density, secondary blood or urine tests and MRI refine who needs a biopsy.

OncoFirm™ status

PSA assay in development (designed range 0.5–50 ng/mL). Research use only; not cleared or approved by the FDA or any other regulatory authority; not for sale.

On this page

Key numbers

Prostate cancer in three numbers

1.55 Mnew prostate cancer cases worldwide in 2024 (GLOBOCAN 2024)
100%US five-year relative survival at localized or regional stage
40.1%US five-year relative survival at distant stage

Sources: IARC Global Cancer Observatory (GLOBOCAN 2024); SEER Cancer Stat Facts: Prostate (SEER 21, diagnoses 2016–2022), accessed 1 October 2026.

Burden

A common cancer with an uneven global burden

Prostate cancer starts in the prostate, a small gland below the bladder in men. GLOBOCAN 2024, the global estimate from the International Agency for Research on Cancer (IARC), counts 1,546,112 new cases and 419,849 deaths in 2024. It is the second most frequent cancer in men and their fourth leading cause of cancer death. This page is part of the OncoFirm™ Cancer Atlas 2026.

The burden is uneven. Africa has 7.2% of new cases but 14.7% of deaths. Northern America has 19.9% of cases and 9.9% of deaths. The contrast points to gaps in access to testing and treatment (see the global need for affordable diagnostics).

In the United States, the American Cancer Society (ACS) expects 333,830 new cases and 36,320 deaths in 2026. Incidence rose by 3% per year from 2014 to 2022, most steeply for advanced-stage disease. Incidence is nearly 70% higher in Black men than in White men, and Black men are about twice as likely to die of the disease.

Why stage matters

Stage and survival: 100.0% when found early, 40.1% when distant

Prostate cancer: five-year relative survival by stage at diagnosisBar chart of five-year relative survival for Prostate cancer by stage at diagnosis in the United States, 2016–2022: Localized 100.0% survival, 69% of cases; Regional 100.0% survival, 14% of cases; Distant 40.1% survival, 9% of cases. All stages combined: 98.2%. Source: SEER Cancer Stat Facts.PROSTATE CANCER · FIVE-YEAR RELATIVE SURVIVAL BY STAGE (US, 2016–2022)0%25%50%75%100%Localized69% of cases100.0%Regional14% of cases100.0%Distant9% of cases40.1%All stages combined: 98.2% · SEER Cancer Stat Facts

Five-year relative survival for prostate cancer by stage at diagnosis, United States, 2016–2022, with the share of cases at each stage (stage was unknown in a further 8%). Source: SEER Cancer Stat Facts: Prostate, accessed 1 October 2026. The ACS reports 38% for distant stage from a different data window.

The chart uses SEER, the US cancer registry program. Relative survival compares people who have the cancer with similar people in the general population. So 100.0% does not mean that no one died. It means five-year survival matched the general population. For 2016–2022, localized disease (69% of cases) and regional disease (14%) both show 100.0%. Distant disease, which has spread to other organs (9% of cases), shows 40.1%.

Most US cases are already found early. The harder question is which early cancers need treatment. Many grow slowly and would never cause harm. Finding those is called overdiagnosis, and it is the main cost of PSA testing. See why early detection matters.

Screening

PSA screening in 2026: a shared decision, not a population program

  • USPSTF (US, final 8 May 2018): grade C for ages 55 to 69 (an individual decision after discussing benefits and harms) and grade D (recommends against) from age 70. An update is in progress; no draft had been posted as of 1 October 2026.
  • ACS: an informed discussion from age 50 at average risk, from 45 for Black men and men with a close relative diagnosed before 65, and from 40 with more than one such relative.
  • AUA/SUO (2023, updated February 2026) and EAU (2026): risk-adapted PSA testing, with MRI before biopsy. EAU offers PSA to well-informed men from 50, from 45 with African descent or a family history, and from 40 for BRCA2 carriers.
  • UK National Screening Committee (28 May 2026): PSA every 2 years only for men aged 45 to 61 with a confirmed BRCA2 gene variant (Cancer Research UK's summary adds a family history of related cancers). It did not back screening for all men, for Black men as a group, or for family history alone.

The main trial is ERSPC, with more than 160,000 men in eight European countries. After a median of 23 years, repeated PSA screening lowered prostate cancer deaths by 13% (rate ratio 0.87, 95% CI 0.80–0.95). Preventing one death required inviting 456 men and diagnosing 12, down from 628 and 18 at 16 years. Screening also raised diagnoses (14% versus 12%), and about half of the extra cancers were judged to be overdiagnosed. The UK CAP trial of a single PSA invitation found only a small absolute reduction in deaths at 15 years.

What PSA is not. No protein tumor marker is recommended for general population cancer screening. PSA is the entry point to a shared decision and a testing pathway. A raised value is not a diagnosis. The early detection evidence hub tracks guideline status.

PSA pathway

The PSA pathway: from one number to a biopsy decision

PSA is a protein made by prostate cells. It rises with cancer, but also with benign enlargement, inflammation, urinary infection and urinary retention. It also varies by 6% to 13% within the same man. Guidelines therefore use a sequence of steps, each meant to spare men a biopsy they do not need.

  1. Total PSA. The quantitative entry test. Guideline decision points sit between about 1 and 20 ng/mL.
  2. PSA density. PSA divided by prostate volume. EAU 2026 allows omitting biopsy after a negative MRI when density is below 0.20 ng/mL/cc (a weak recommendation).
  3. Secondary tests. For PSA of 3 to 20 ng/mL, EAU lists a calibrated risk calculator or an added blood or urine test as options (weak). Examples: free-to-total PSA ratio, PHI, 4Kscore, Stockholm3 and the urine test MyProstateScore 2.0.
  4. MRI before biopsy. A strong EAU recommendation. In the GÖTEBORG-2 trial, biopsy of MRI-visible targets only cut detection of low-grade (Gleason 6) cancers by half, with delayed detection of a few intermediate-risk tumors.
  5. Targeted biopsy. Tissue is still needed to diagnose and grade prostate cancer.

In the multi-ethnic SEPTA study (2,129 men), Stockholm3 had similar sensitivity to PSA at 4 ng/mL (relative sensitivity 0.95) and about three times the specificity, and could have avoided 45% of benign or low-grade biopsies. MyProstateScore 2.0 reported 95% sensitivity for higher-grade cancer, but only 4% of its validation group was African American. Such studies use different thresholds and populations, so their numbers cannot be compared directly. All of these tests follow a raised total PSA; none replaces it. See multi-biomarker analysis.

Biomarkers

Prostate biomarkers by role

BiomarkerTypeUsed forNot used for
Total PSASerum proteinEntry test in shared-decision early detection; monitoring after treatmentDiagnosis on its own; population screening
PSA density, free PSA ratioPSA-derived measuresRefining biopsy decisions after a raised PSAFirst-line testing
Stockholm3, 4Kscore, PHIMulti-marker blood testsOptional triage before MRI or biopsyReplacing total PSA
MyProstateScore 2.0Urine RNA testOptional biopsy triage (laboratory-developed test, not FDA approved)Screening
BRCA2Inherited risk geneEarlier PSA testing (EAU from 40; UK NSC ages 45–61)Diagnosis
PSMA PETImagingStaging high-risk diseaseScreening

PSMA PET is a scan that marks a protein on prostate cancer cells. In the proPSMA trial it staged high-risk disease more accurately than CT plus bone scan (92% versus 65%). PSA also has a monitoring role: recurrence after prostate removal is commonly defined at about 0.2 ng/mL. For marker roles in general, see cancer biomarkers explained and our PSA guide.

Standards

The WHO PSA standard, and why assays still disagree

A PSA result depends on the assay that produced it. To anchor calibration, the World Health Organization (WHO) maintains reference materials. For total PSA the current one is the 2nd WHO International Standard, NIBSC code 17/100. It was established in 2018, contains 0.50 µg of total PSA per ampoule, and replaced the first standard (96/670). A companion standard, 17/102, covers free PSA.

Traceable does not mean interchangeable. A 2026 review reported that WHO-calibrated values on one major assay run about 20% lower than values under the older Hybritech calibration. When two WHO-calibrated assays were compared, results differed by more than 20% in 74% of patients. The familiar cut-offs of 4 ng/mL and about 3 ng/mL (used in ERSPC) were each set on specific assays.

Emerging

Emerging approaches in 2025–2026

  • AI on MRI. In the PI-CAI study of 10,207 MRI exams, an AI system reached an AUROC (a 0-to-1 accuracy score) of 0.91 versus 0.86 for radiologists, with 50.4% fewer false positives at the same sensitivity. This was a retrospective study; prospective screening evidence is missing.
  • AI on biopsy slides. The FDA has authorized a few prostate pathology algorithms, including Paige Prostate (2021), Ibex Prostate Detect (January 2025) and ArteraAI Prostate (July 2025). See AI in cancer diagnostics.
  • Multi-cancer blood tests. These find prostate cancer poorly: in the NHS-Galleri trial, the Galleri test's sensitivity for prostate cancer was 10.7%. No multi-cancer early detection test is FDA approved as of 1 October 2026. An FDA panel backed Galleri on 23 September 2026 and the decision is pending. NHS-Galleri missed its primary endpoint. More in emerging diagnostic technologies.
  • Glycan antigens. The Thomsen-Friedenreich (TF) antigen, a sugar structure on tumor cells, has been studied in prostate cancer as a vaccine target. No clinical TF assay for prostate cancer exists. See tumor-associated antigens.

Open questions

Open research questions

  • Does organized screening with MRI lower deaths with acceptable overdiagnosis? ERSPC predates MRI. The UK NSC points to the TRANSFORM trial as the route to revisiting its decision.
  • Which secondary test works best, and in what order, before MRI?
  • Do biomarkers and risk tools perform equally well in Black men, who carry the highest burden?
  • Why is distant-stage disease rising in the United States?
  • Can PSA assays be harmonized so that one cut-off means the same on every platform?

OncoFirm™ roadmap

Where OncoFirm™ fits: quantitative PSA, in development

PSA is a lead analyte for the OncoFirm™ fluorescent lateral flow platform. The assays, reader and software are in development. They are not cleared or approved by the FDA or any other regulatory authority, are for research use only and are not for sale. OncoFirm™ makes no screening claims.

Designed range

The PSA assay is designed to measure 0.5–50 ng/mL, which spans the guideline decision points from about 1 to 20 ng/mL. It does not reach the values near 0.2 ng/mL used after prostate removal. See the PSA guide.

Planned traceability

Calibration is planned to be traceable to the WHO 2nd International Standard for total PSA (17/100). Traceable does not mean interchangeable, so method comparison studies are a required step. Read about the platform.

Reader and time target

A digital reader converts the strip signal into a number. The result-time target is 20 minutes or less, which is a development target.

Evidence still needed

Precision, detection limit, hook effect, interference and comparison with laboratory analyzers must be shown before any clinical use. Research groups can ask about collaboration.

OncoFirm™ assays, reader and software are in development, have not been cleared or approved by the FDA or any other regulatory authority, are for research use only and are not for sale. Designed ranges and result times are development targets, not validated performance claims.

FAQ

Frequently asked questions

Is PSA screening recommended for all men?

No. The USPSTF (2018) gives a grade C (an individual decision) for ages 55 to 69 and recommends against screening from age 70. In May 2026 the UK National Screening Committee recommended PSA testing only for men aged 45 to 61 with a BRCA2 gene variant.

What PSA level means cancer?

No single PSA level proves or rules out cancer. PSA also rises with benign prostate enlargement, inflammation and infection, and it varies between assays. A raised result leads to further steps, such as PSA density, a secondary test and MRI, before a biopsy is considered.

What is the WHO PSA standard?

It is a reference material used to calibrate PSA assays. The current one for total PSA is the 2nd WHO International Standard, NIBSC code 17/100, established in 2018. Assays traceable to it can still give different results, so serial testing should stay on one method.

Can a multi-cancer blood test find prostate cancer?

Not well so far. In the NHS-Galleri trial, the Galleri test's sensitivity for prostate cancer was 10.7%. No multi-cancer early detection test is FDA approved as of 1 October 2026.

Does OncoFirm™ sell a PSA test?

No. The OncoFirm™ PSA assay, reader and software are in development and are for research use only. They are not cleared or approved by the FDA or any other regulatory authority and are not for sale.

Sources

References

  1. IARC Global Cancer Observatory. Prostate fact sheet, GLOBOCAN 2024. gco.iarc.who.int/media/globocan/factsheets/cancers/27-prostate-fact-sheet.pdf
  2. Sung et al. Global cancer statistics 2024: GLOBOCAN estimates for 34 cancers in 186 countries. CA Cancer J Clin. 2026. acsjournals.onlinelibrary.wiley.com/doi/10.3322/caac.70090
  3. American Cancer Society. Cancer Facts & Figures 2026. www.cancer.org/content/dam/cancer-org/research/cancer-facts-and-statistics/annual-cancer-facts-and-figures/2026/2026-cancer-facts-and-figures.pdf
  4. Kratzer et al. Prostate cancer statistics, 2025. CA Cancer J Clin. 2025. acsjournals.onlinelibrary.wiley.com/doi/full/10.3322/caac.70028
  5. National Cancer Institute. SEER Cancer Stat Facts: Prostate Cancer. Accessed 1 October 2026. seer.cancer.gov/statfacts/html/prost.html
  6. US Preventive Services Task Force. Prostate Cancer: Screening. Final recommendation, 8 May 2018. www.uspreventiveservicestaskforce.org/uspstf/recommendation/prostate-cancer-screening
  7. American Cancer Society. Recommendations for Prostate Cancer Early Detection. Revised 22 November 2023. www.cancer.org/cancer/types/prostate-cancer/detection-diagnosis-staging/acs-recommendations.html
  8. American Urological Association. Updates to the Early Detection of Prostate Cancer guideline. 26 February 2026. www.auanet.org/about-us/media-center/press-center/aua-announces-updates-to-the-early-detection-of-prostate-cancer-guideline
  9. EAU-EANM-ESTRO-ESUR-ISUP-SIOG. Pocket Guidelines on Prostate Cancer 2026. d56bochluxqnz.cloudfront.net/documents/pocket-guidelines/EAU-EANM-ESTRO-ESUR-ISUP-SIOG-Pocket-on-Prostate-Cancer-2026_2026-03-14-103741_ikpf.pdf
  10. Cancer Research UK. UK NSC recommends prostate cancer screening for men with a BRCA2 gene change and family history of cancer. 28 May 2026. news.cancerresearchuk.org/2026/05/28/uk-nsc-recommends-prostate-cancer-screening-for-men-with-a-brca2-gene-change-and-family-history-of-cancer/
  11. Roobol et al. ERSPC 23-year follow-up. N Engl J Med. 2025;393(17):1669–1680. Figures as reported by The ASCO Post and the ERSPC consortium. www.nejm.org/doi/full/10.1056/NEJMoa2503223
  12. Martin et al. CAP trial of a single PSA screening invitation, 15-year analysis. JAMA. 2024 (journal news release, 6 April 2024). www.eurekalert.org/news-releases/1040045
  13. Vigneswaran et al. Stockholm3 in a multiethnic cohort (SEPTA). J Clin Oncol. 2024. ascopubs.org/doi/10.1200/JCO.24.00941
  14. UroToday. SUO 2024: Prostate cancer screening with biomarkers and MRI, a European perspective (GÖTEBORG-2 data). www.urotoday.com/conference-highlights/suo-2024/suo-2024-prostate-cancer/156745-suo-2024-prostate-cancer-screening-with-biomarkers-and-mri-a-european-perspective.html
  15. NCI Division of Cancer Prevention. Improved prostate cancer biomarker test may help men avoid unnecessary biopsy (MyProstateScore 2.0). 2024. prevention.cancer.gov/news-and-events/blog/improved-prostate-cancer-biomarker-test-may-help-men-avoid-unnecessary-biopsy
  16. NIBSC. Prostate specific antigen (human) (total: PSA-ACT + free PSA), 2nd WHO International Standard, code 17/100. Instructions for use. nibsc.org/documents/ifu/17-100.pdf
  17. Filella X. Review of persisting differences among PSA assays after WHO-based standardization. Tumor Biology. 2026. journals.sagepub.com/doi/10.1177/14230380261466593
  18. Association of Clinical Biochemists in Ireland. Guidelines for the Use of Tumour Markers, 5th edition. 2018. acbi.ie/wp-content/uploads/2022/12/1644913336-1602832758-Tumour-markers-5th.pdf
  19. Duffy MJ. Tumor markers in clinical practice: a review. Med Princ Pract. 22(1):4. karger.com/mpp/article/22/1/4/203271/Tumor-Markers-in-Clinical-Practice-A-Review
  20. National Cancer Institute. PSMA PET-CT accurately detects prostate cancer spread (proPSMA trial, Lancet 2020). 2020. www.cancer.gov/news-events/cancer-currents-blog/2020/prostate-cancer-psma-pet-ct-metastasis
  21. Saha et al. Artificial intelligence and radiologists in prostate cancer detection on MRI (PI-CAI). Lancet Oncol. 2024. www.thelancet.com/journals/lanonc/article/PIIS1470-2045(24)00220-1/abstract
  22. Innolitics. AI/ML in digital pathology and the software as an IVD paradigm: 2026 snapshot. innolitics.com/articles/ai-ml-in-digital-pathology-and-the-software-as-an-ivd-paradigm-snapshot/
  23. Targeted Oncology. FDA panel report on the Galleri multi-cancer early detection test. September 2026. www.targetedonc.com/view/fda-panel-galleri-multi-cancer-early-detection-test
  24. Slovin et al. Thomsen-Friedenreich (TF) antigen as a target for prostate cancer vaccine: clinical trial results. 2005. www.researchgate.net/publication/8007964_Thomsen-Friedenreich_TF_antigen_as_a_target_for_prostate_cancer_vaccine_Clinical_trial_results_with_TF_cluster_c-KLH_plus_QS21_conjugate_vaccine_in_patients_with_biochemically_relapsed_prostate_cancer

About this article. Compiled from public sources read on 1 October 2026. Several trial figures come from published summaries of the primary papers, and guideline or regulatory status may change after that date. Part of the OncoFirm™ Cancer Atlas 2026, written by the OncoFirm™ Scientific Team from the sources linked above and reflecting public information as of 1 October 2026. It is for education and is not medical advice. OncoFirm™ has no affiliation with the companies or tests named. OncoFirm™ assays are in development, have not been cleared or approved by the FDA and are not available for sale.

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