With Jeremy Clarkson recently sharing his diagnosis and treatment, the conversation around prostate cancer and men’s health is firmly back in the spotlight.
Reflecting on Men’s Health Week, Adele Fletcher and Sabrina Mahmood in our Healthcare Litigation team consider the limitations of current testing methods and explore the legal issues which can arise in medical negligence claims involving prostate cancer.
Despite 1 in 8 men receiving a diagnosis of prostate cancer, this type of cancer often develops insidiously. Due to the way it grows, many men in the early stages will not experience any signs or symptoms. This is frequently the case where the cancer remains confined to areas of the prostate away from the urethra.
At the current time, there is no single definitive test for prostate cancer. In primary care, the main investigations include urine tests (to rule out a urine infection), digital rectal exam (DRE) or a Prostate Specific Antigen (PSA) blood test.
Where a patient presents with symptoms or concerns about prostate pathology, NICE guidance provides a framework for investigation. Clinicians should consider performing a DRE, which enables a clinical assessment of the prostate for signs of prostate cancer. If the prostate feels abnormal or malignant on examination, an urgent suspected cancer pathway referral (for an appointment within two weeks) should be made.
PSA testing also remains a key diagnostic tool. The NICE guidelines state that, before proceeding with PSA testing, clinicians are required to provide sufficient information to enable the patient to understand its benefits and limitations. PSA testing should then be offered once the patient has provided their informed consent.
However, PSA testing does come with limitations, which could be why there is currently no national screening programme for prostate cancer in the UK. The test lacks both specificity and sensitivity, meaning that elevated PSA levels may arise from benign conditions such as urinary tract infection or benign prostatic enlargement. As a result, it can produce both false positive and false negative results. In addition, it may lead to overdiagnosis, identifying cancers that would not have caused harm during the patient’s lifetime. For these reasons, PSA testing is not suitable as a universal or unilateral screening tool and must be interpreted cautiously within the wider clinical context, with patients appropriately advised of its limitations.
The National Screening Committee (UK NSC) is the independent body responsible for making recommendations to government on screening programmes. Based on scientific evidence, the UK NSC has recommended targeted screening for those at higher risk of prostate cancer, rather than routine screening. Whilst the Government accepted these recommendations earlier this month, it has jointly provided funding of £60m with Prostate Cancer UK for the TRANSFORM trial. This trial is designed to identify the ideal screening method for prostate cancer with the aim of establishing all men at risk and inviting for regular tests for aggressive cancers to enable timely treatment.
In addition to the limitations of PSA testing, NICE guidance also emphasises that referral decisions should not be based on PSA levels alone and suggests that referral where a raised result has been received is not mandatary. A patient should be considered for referral via the urgent suspected cancer pathway if their PSA level exceeds the age-specific threshold, taking into account their clinical presentation, comorbidities and personal preferences.
Once a referral is made via the urgent suspected cancer pathway, further investigations in secondary care typically include MRI imaging and, where indicated, prostate biopsy, which together assist in confirming diagnosis and determining disease staging as well as its location.
Legal claims often occur where patients sadly experience a delay in diagnosis or treatment. We have recently seen claims in which raised PSA test results were either not adequately followed up or communicated to patients, preventing the timely initiation of treatment.
In addition to delays in diagnosis and treatment, a number of other areas appear vulnerable to potential claims. There could be failures to ensure appropriate onward referral, particularly where the urgent cancer referral pathway is indicated or where there have been breakdowns in administrative processes, leading to hospital appointments not being arranged or received. Delays may also have arisen due to patient embarrassment associated with undergoing assessment or treatment.
Our extensive experience in healthcare claims demonstrates that failures in communication and informed consent remain a consistent and central theme in litigation. This is particularly relevant in the context of PSA testing. Given the clear expectations set out in the NICE guidelines, patients should understand that this testing has limitations and cannot always be reliable for diagnosing prostate cancer. A failure to adequately counsel patients on these uncertainties as well as the risk of false positive and negative results, may increase exposure to legal claims.
Related to this is the issue of overdiagnosis and overtreatment. Many prostate cancers may never cause harm during a patient’s lifetime. However, detection through PSA screening can lead to unnecessary anxiety, invasive investigations, and treatment-related side effects. Claims may arise where patients argue that they were not properly informed of these risks prior to testing or treatment and that they could have otherwise avoided invasive investigations and treatment.
Despite increasing awareness there continues to be a stigma surrounding prostate health. Factors such as embarrassment, fear, and perceptions of masculinity may deter patients from seeking advice or engaging with investigations. This has the potential to delay diagnosis and treatment.
Clinicians should remain alert to these barriers and not only encourage early presentation but recognise that patient centred communication is fundamental when such steps are taken. Creating an open environment in which patients feel comfortable discussing sensitive symptoms can improve disclosure and support appropriate assessment. Communication should be clear, empathetic and tailored to the individual. Applying this approach can help to make sure that decisions regarding investigations and treatment are made collaboratively.
Clinicians should ensure patients are informed of the purpose, options, benefits, limitations, and material risks of any proposed intervention, including those of particular significance to individual patients, along with any rationale behind recommendations or decisions. Any appointments should be followed by clear and contemporaneous records detailing discussions, including patient questions, to evidence collaborative dialogue and decision making.
When results become available, they should be communicated promptly to referring clinicians or patients in a manner the patient is able to understand. This includes explaining clinical significance, implications, available next steps and, if appropriate, clearly identifying who is responsible for follow up treatment or care, enabling informed participation.
We are becoming more aware of patients attending private PSA testing clinics to alleviate their concerns regarding prostate cancer. Investigations being completed outside the usual NHS setting further highlight the need for robust systems to ensure results are communicated, both to patients and referring clinicians, positive or otherwise. This allows continued involvement for patients in their care choices.
Unfortunately, delays may arise within primary and secondary care due to administrative or process failures. However, robust systems should be in place to track results and follow ups, ensuring the risk of such occurrences is minimised. Early experience with clinical engagement and communication is, again, important here. This approach can impact whether patients feel empowered to seek clarification if results or appointments are not received as expected.
Previous celebrity cancer diagnoses have prompted the general public to take up offers of cancer-related testing, and we anticipate recent press will prompt similar action. In light of this, and the wrongful assumption that PSA testing is routinely available, GPs approached for such tests will need to balance their duty to avoid over testing, given the associated risks and pressures on the NHS, against the patient expectations. Any decisions relating to this will need to be carefully documented to ensure the patient remains fully informed, continues to be alive to any ongoing risks, and is clear on the rationale for not offering a PSA test.
Prostate cancer diagnosis is inherently complex, often with subtle signs and symptoms, and imperfect testing and diagnosis pathways. The key takeaway from a legal and risk perspective is that clinicians can and must proactively overcome diagnosis and treatment barriers through clear, empathetic, patient‑centred communication, robust consent and follow‑up processes, and timely sharing of results to support informed and collaborative care.
If you have any questions or would like advice on clinical negligence or healthcare matters, please contact Adele Fletcher or Sabrina Mahmood, Associates - Healthcare & Sport.
If you have personal concerns, visit Prostate Cancer UK where you can check your risk.
The service you deliver is integral to the success of your business. With the right technology, we can help you to heighten your customer experience, improve underwriting performance, and streamline processes.
