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Expert insights for November – Associate Professor Francesco Giganti

What do you think are the 3 most significant practice breakthroughs in prostate cancer diagnosis in 2024?

The first is the integration of artificial intelligence (AI) in the diagnostic pathway of prostate cancer. Its adoption has significantly improved the interpretation of imaging data and patient stratification. Advanced AI algorithms can assist radiologists in evaluating MRI scans and other imaging modalities, increasing accuracy and efficiency in diagnosing and categorising patients, including those suitable for active surveillance (AS). This integration reduces human error and enhances personalised treatment planning.

The second the constant increased uptake of MRI and PSMA-PET, which have become a cornerstone in prostate cancer diagnostics. This dual-modality approach offers unparalleled sensitivity and specificity, allowing for more precise localisation and staging of prostate cancer.

The third is the roe of liquid biomarkers. The utilisation of liquid biomarkers, including circulating tumour cells (CTCs) and cell-free DNA, has revolutionised non-invasive diagnostics. These biomarkers enable early detection, monitoring of disease progression, and response to treatment, providing a less invasive alternative to traditional tissue biopsies.

What have been the most important publications in prostate cancer diagnosis in the first half of 2024?

The first is the PI-CAI study published in The Lancet Oncology. It highlights the efficacy of AI in enhancing the accuracy of prostate cancer diagnostics. An AI system was superior to radiologists, on average, at detecting clinically significant prostate cancer and comparable to the standard of care. However, prospective validation is needed to test clinical applicability of this system.

The second is the updated version of the Prostate Imaging Quality score (PI-QUAL v2), published in European Radiology. The new standardised scoring system for MRI quality, can be used both for multiparametric MRI and MRI without intravenous injection of contrast medium (i.e., biparametric MRI) and will help global consistency in the acquisition of images of adequate diagnostic quality.

The third is the PROBASE trial published in  European Urology. It has shown that prostate MRI accuracy is moderate for men aged 45 years but can be increased by a second reading of the images by expert radiologists. Therefore, for broad application of MRI in routine screening, double reading should be advisable.

In 3-4 months – What do you think will be the next 2-3 big changes in prostate cancer diagnosis, when and why?

 The first is the development of novel biomarkers and liquid biopsy technologies, which is expected to enhance early detection and reduce the need for invasive procedures.

The second is the improvement of Imaging Quality Standards using dedicated standardised scoring systems like PI-QUAL v2. Initiatives aiming at improving image quality globally to facilitate better diagnosis and management decisions are already under way (e.g. American College of Radiology).

 

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Expert insights for September – Professor Anwar Padhani

Let’s talk about prostate cancer diagnosis and what we expect to happen over the next year or so.  When I started thinking about this topic, I asked myself three questions:

    • What are the most recent changes in the way we think about prostate cancer diagnosis?
    • What have been the most important publications, guideline changes, and conference presentations recently?
    • What will be the next big changes in the MRI diagnostic pathway, and why and how will these happen?

Let’s start by considering the main benefits of the MRI pathway compared to traditional prostate cancer diagnosis. Benefits arise from accurate results, including true negatives, which improve the negative predictive value. In the early detection setting, MRI can reduce the number of patients undergoing unnecessary biopsies and the diagnosis of indolent cancers. True positive results allow for more accurate targeted biopsies and tumour grading. MRI is not inferior in detecting clinically significant cancers in biopsy-naive men.

Early disease detection refers to identifying men with a high likelihood of having clinically significant cancers, typically those who present themselves at a urological clinic. This differs from screening, which targets a healthy population to identify individuals who may have harmful cancers. The key difference is the pretest probability or cancer prevalence.

The modern MRI pathway, as depicted in the EAU guidelines, involves risk-based assessments by urologists, followed by MRI, and subsequent evaluation for the need for biopsy. These assessments help reduce the number of men undergoing unnecessary investigations, thereby minimising harm without compromising the detection of clinically significant cancers. The benefits include timely treatment and reduced overdiagnosis and biopsy rates. Harm can result from false positives (unnecessary biopsies) and false negatives (missed cancers).

A fundamental foundation of this pathway is PIRADS compliance, ensuring the protocol is followed as prescribed. This is crucial because higher suspicion levels for clinically significant cancers increase the likelihood of finding them. Quality assurance is another foundational element, involving automation, image quality checks, certification of personnel, and accreditation of diagnostic centres.

Patient preferences also play a role. Younger patients with strong family histories or those of Black ethnicity may be more cancer-averse, prioritizing detection over concerns about biopsy complications. In contrast, older patients with comorbidities may be more concerned about biopsy risks and less about low-risk disease.

We also need to consider the balance of benefits and harms in decision-making. Decision curve analysis helps assess the net benefit of MRI by weighing cancer detection against patient preferences for biopsy, depending on pretest probability. Analysis highlights how MRI can be more effective in detecting clinically significant cancers, especially when the threshold probability is low.

Looking ahead, we expect to see more use of MRI without contrast medium, especially in cases where image quality is high and for expert readers. Recent studies have shown that biparametric MRI can be as effective as multiparametric MRI in yielding biopsy results for clinically significant cancers. However, this shift will require further confirmation from prospective randomised studies.

Additionally, we anticipate more data on reader variability from the PI-CAI challenge, focusing on deep learning and computer-aided detection. Recent findings suggest that AI can outperform radiologists using the PIRADS system, with fewer false positives and false negatives. The upcoming PARADIGM study will test the hypothesis that AI is not inferior to radiologists in diagnosing clinically significant cancers.

We are also seeing advancements in risk calculators that incorporate PIRADS scores, PSA levels, and AI to refine biopsy decisions. A recent study demonstrated that a deep learning algorithm outperformed PIRADS with PSA density, suggesting a potential future where AI might replace radiologists Nomograms.

Furthermore, we foresee a shift toward targeting only what is seen on MRI or AI analysis for biopsy and treatment, as supported by the EAU 2024 guidelines. This approach minimises the need for systematic biopsies.

In conclusion, the future involves new thinking about early detection versus screening, risk-based patient assessments, and accounting for patient preferences. The MRI pathway requires optimisation through adherence to PIRADS guidelines, quality assurance, automation, AI, and personalised protocols. Integration with clinical biomarkers and multidisciplinary collaboration will also be essential. Quality monitoring and key performance indicators will ensure the pathway’s effectiveness and safety.

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Sectra distribution agreement via Amplifier

Lucida Medical Ltd announces a distribution agreement with Sectra to offer Pi AI technology to help diagnose prostate cancer

Lucida Medical today announced that it has signed a distribution agreement with international medical imaging IT and cybersecurity company Sectra. Through this agreement, the Lucida Pi application for diagnosing prostate cancer from MRI images will be offered through the Sectra Amplifier Marketplace. This greatly expands the availability of Pi to assist healthcare by improving the speed and accuracy of prostate cancer diagnosis.

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Macmillan Invest in Lucida AI

Macmillan Cancer Support is investing in Lucida Medical, a spin-off from the University of Cambridge that develops Pi™ software to help radiologists find cancer

Macmillan Cancer Support, the UK’s leading cancer charity, is investing £350,100 in Lucida Medical’s pioneering new AI platform, Pi™, with the aim of improving the speed and accuracy of prostate cancer tests. This could help to improve early detection and treatment and reduce the number of cancer-free patients going through more invasive investigative procedures, as well as potentially saving NHS time and money.

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