Novel Prostate Cancer Screening Methods To Reduce Unnecessary Biopsies
Novel methods to screen for prostate cancer could improve risk stratification of suspected cases.
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Prostate cancer is the second most common cancer in men, with more than 1.4 million new cases reported globally in 2020, resulting in over 375,000 deaths.1 Current screening methods involve a blood test to check for the prostate-specific antigen (PSA) level, which aims to detect cancer at an early stage, allowing for timely intervention and improved patient outcomes. However, this method is known to generate an alarming number of false positive results, leading to unnecessary biopsies and unnecessary stress for patients. This has prompted researchers to explore novel methods to screen for prostate cancer, including an in vitro diagnostic test that uses telomere associated variables (TAVs) in conjunction with PSA measurements to improve risk stratification of suspected cases.
Current screening practices
The screening and diagnosis of prostate cancer remains a challenge. Elevated PSA levels continue to be the principal diagnostic method worldwide, together with the display of prostatic symptoms and an abnormal digital rectal examination (DRE). However, the value of PSA testing is still under debate, with one large systematic review finding that this method only accounted for a slight reduction in prostate cancer-specific mortality over 10 years.2 Individuals with high levels of PSA generally get referred for a biopsy – an invasive, painful and costly procedure – which can lead to short-term complications, or even risk overdiagnosis and overtreatment.2 In fact, cancer is identified in only around one-third of men who undergo a biopsy,3 highlighting the need for complementary approaches to aid risk stratification of patients before this procedure.
Telomeres – the next frontier
Telomeres have long been recognized as biomarkers for biological age but, more recently, they’ve also been identified as predictive and prognostic markers for oncological diseases. This concept was studied in the Horizon 2020 funded ONCOCHECK project, in which the Spanish biotech company Life Length aimed to clinically validate TAVs as a biomarker for both hematological and solid tumors. The project was particularly successful at identifying lung and prostate cancers, the latter study involving 1,200 men who all underwent prostate biopsies. This cohort demonstrated improved diagnoses overall, allowing the company to develop highly precise and predictive algorithms to determine a patient’s risk of having prostate cancer.
This approach has since been developed into ProsTAV®, a state-of-the-art in vitro diagnostic assay to identify patients with an elevated risk of suffering from aggressive prostate cancer. The company uses an advanced algorithm and machine learning techniques to analyze a range of data sets – including a patient’s age, PSA level, DRE results and TAVs – to generate a prostate cancer risk score between zero and 100. The patient’s doctor can then use this score, as well as other screening factors, to decide whether to refer them for a biopsy.
More samples, better accuracy
Following the success of the project, the company ramped up its operations and invested in a number of laboratory automation solutions to accelerate its workflow and increase efficiency. All the assays are now prepared on either Fluent® or Freedom EVO® laboratory automation platforms (Tecan), allowing the company to automate many of its complex tasks. For example, the workflow includes a series of wash steps to remove cellular membranes – an extremely delicate process to avoid damaging the chromosomes – which can be safely automated on the Tecan instruments. The 384-channel pipetting head of the Fluent platform’s Multiple Channel Arm™ provides greater repeatability over manual or even semi-automated methods, while the Freedom EVOware® Sample Tracking software delivers end-to-end traceability of each sample prepared on the Freedom EVO platform. These technologies have allowed the company to run more samples in a day, significantly increasing throughput and ensuring that samples are accurately processed and linked back to the correct patient.
The efficiency and accuracy of PSA testing are highly debated in the medical community, as this approach frequently leads to unpleasant prostate biopsies being performed on men who don’t necessarily need them. TAVs have been shown to be an effective biomarker for identifying prostate cancer, and could be used in combination with other screening methods to help triage patients in need of further examination. This could virtually eliminate unnecessary biopsies, generating significant clinical benefits for patients and returning substantial economic savings for both public and private healthcare systems. As this method continues to expand and scale up, laboratory automation technologies will be essential to ensure patients receive timely and accurate results.
About the author:
Stefan Haberstock is head of NGS enablement and marketing at Tecan.
References
1. Wang L, Lu B, He M, Wang Y, Wang Z, Du L. Prostate cancer incidence and mortality: global status and temporal trends in 89 countries from 2000 to 2019. Front Public Health. 2022;10:811044. doi: 10.3389/fpubh.2022.811044
2. Ilic D, Djulbegovic M, Jung JH, et al. Prostate cancer screening with prostate-specific antigen (PSA) test: a systematic review and meta-analysis. BMJ. 2018:k3519. doi: 10.1136/bmj.k3519
3. Welch HG, Fisher ES, Gottlieb DJ, Barry MJ. Detection of prostate cancer via biopsy in the Medicare-SEER population during the PSA era. J Natl Cancer Inst. 2007;99(18):1395-400. doi: 10.1093/jnci/djm119
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