ANGLE plc has signed a master clinical study agreement with Solaris Health Holdings, LLC and joinder agreements with MidLantic Urology LLC, to collaborate and conduct clinical studies in prostate cancer and as a potential route to market in the U.S.
Alongside Solaris affiliate MidLantic Urology, UK-headquartered ANGLE will initiate clinical studies aimed at detecting prostate cancer and predicting its severity in patients who present with an elevated prostate specific antigen (PSA) level and/or abnormal digital rectal exam. The studies will use ANGLE’s Parsortix system, a circulating tumor cell (CTC) harvesting technology.
The design of the first study to be conducted with MidLantic Urology, expected to be initiated in Q3 2022, has been aided by earlier pilot studies at the Barts Cancer Institute (Queen Mary University London), which used the Parsortix system to harvest CTCs.
This study will initially enrol 100 men scheduled to undergo a prostate tissue biopsy at a minimum of three study sites over an anticipated period of up to nine months. Blood samples collected by MidLantic Urology will be shipped to ANGLE’s U.S. clinical laboratory for processing by the Parsortix system to harvest and analyse CTCs and associated immune cells.
These will be evaluated by both imaging and molecular analysis to assess the potential to predict the presence of clinically significant prostate cancer prior to tissue biopsy and to assess potential correlation with established disease severity scores in those patients found to have prostate cancer.
ANGLE said it expects results in 2023. It added data could form the basis of a laboratory developed test, and Solaris could be ANGLE’s first route to market for this test, offering the established test to their patient base. Successful results could also allow the design of a larger validation study to support an eventual submission to the U.S. Food and Drug Administration (FDA) and other regulatory bodies.
Prostate cancer is the leading cause of cancer in men and accounts for 13% of all new cancer cases in the U.S. Under the national screening program, 11 million men will undergo a PSA test in the US each year. Of these, some 1.2 million will have an abnormal result, leading to further investigations.
The current standard of care, transrectal or transperitoneal prostate tissue biopsy, is an invasive procedure associated with significant clinical complications and cost. Following the procedure, 32% of patients are reported to experience moderate side effects, with 1.4% of patients experiencing major complications. This includes post-biopsy sepsis in 2-5% of cases with up to 25% requiring admission to ICU at an estimated cost of $19,000 per patient.
Prostate tissue biopsies are negative in 75% of patients and place patients at unnecessary risk but may also miss the cancer in 30-40% of cases, requiring patients to undergo repeat tissue biopsy. At least 60% of prostate cancers diagnosed are unlikely to cause harm during a patient’s lifetime. However, many men undergo radical prostatectomy, which can be associated with post-procedure complications including urinary incontinence and erectile dysfunction.
According to ANGLE, liquid biopsy offers the potential for a safer, more cost-effective diagnosis, active surveillance where appropriate and, following diagnosis, the ability to offer monitoring and targeted treatment selection.
Dr Jose Moreno, principal investigator at MidLantic Urology, said, “Even though PSA is a valuable marker of response to prostate cancer treatment, its role in screening is modest at best and can lead to both overdiagnosis of clinically indolent prostate cancer and underdiagnosis of clinically significant prostate cancer which can result in increased rates of local failure and metastatic disease.”
He added: “ANGLE’s Parsortix platform has the potential to enable molecular characterisation of the cancer using a blood test in patients undergoing both traditional ultrasound biopsies and MRI fusion biopsies. The preliminary data suggest that we may be able to create an assay for the detection of clinically significant prostate cancer that has high specificity and sensitivity.
“Moreover, the assay can be customized to operate in a wide spectrum of prostate cancer disease states, including pre-prostate biopsy, after a negative biopsy, active surveillance, after local failure, and in early and late metastatic disease states. If our results are validated, our MidLantic Urology patients and Solaris Health affiliates may be the first to benefit from these developments.”
ANGLE founder and chief executive, Andrew Newland, added the successful development of the blood test could prevent men from being subjected to unnecessary tissue biopsies when they either do not have prostate cancer (despite the elevated level of PSA) or their cancer is indolent and unlikely to impact either their life expectancy or quality of life.
“The funding for this study, which addresses a major unmet medical need, was a key element of our capital raise last year and could open up a significant market opportunity for ANGLE,” Newland said. “Initiation of the study, expected in the near future, delivers on another business milestone as we build out our commercial plans for the Parsortix system.”
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