Prostate cancer is the second most common cancer in men, with 1 in 8 diagnosed in their lifetime. This equates to approximately 1.4 million men diagnosed globally each year, with a further 5 million living with the disease.
Many developed nations offer population-based screening for men. For example, in the United States, the Preventive Services Task Force recommends that all men between the ages of 55-69 years be offered annual prostate screening using a blood-based prostate specific antigen (PSA) test.
Abnormalities in PSA levels can indicate complications in prostate function, including cancer. Under this programme an estimated 11 million men were screened in 2018 with 1.5 million men returning an abnormal PSA result. This led to approximately 1 million follow up prostate tissue biopsy procedures with a high incidence of complications.
The PSA assay is known to have poor sensitivity and specificity, at 21% and 91%, respectively. See: https://www.uptodate.com/contents/screening-for-prostate-cancer. As a result, many men may undergo a prostate biopsy unnecessarily. ANGLE’s circulating tumour cell (CTC) based liquid biopsy could potentially offer a unique opportunity to triage men with elevated PSA, avoiding the need for invasive core tissue biopsy for the majority of patients with benign or indolent disease.
Key statistics
2nd
most common cancer in men
1 in 8
men diagnosed in their lifetime
1.4 million
men diagnosed globally each year
21%
sensitivity with current screening tests
5 million
men living with prostate cancer
The Parsortix®system has shown the potential to detect more severe cancer cases, where the patient is likely to die, sooner thereby providing information which may enable clinicians to provide different treatment for their patients, potentially extending the lives of those battling with cancer.”
Dr Yong-Jie Lu
Professor in Molecular Oncology at Barts Cancer Institute
In May 2022, ANGLE formalised a partnership with a major specialist clinical service provider, MidLantic Urology, to initiate ANGLE’s first clinical study in prostate cancer.
The purpose of the study is to evaluate whether ANGLE’s novel liquid biopsy assay, in combination with current standard of care (PSA levels, patient history and physical examination), can reduce the over-detection of indolent prostate cancer whilst identifying aggressive disease.
This could improve patient stratification, reducing unnecessary patient harm and hospitalisation from tissue biopsy complications, as well as avoiding over-diagnosis and treatment.
The study, known as ‘DOMINO’, is based on highly successful pilot studies conducted independently by Barts Cancer Institute (Queen Mary University London). DOMINO will enrol 100 men with either an elevated blood PSA or an abnormal rectal exam, who are scheduled to undergo a prostate tissue biopsy.
Blood samples collected by MidLantic Urology will be shipped to ANGLE’s clinical laboratory in the United States for processing on the Parsortix system Harvested CTCs and associated immune cells will then be analysed using a combination of imaging and molecular assays.
Patients will be followed-up to determine if the presence and/or number of these rare cells can identify patients with clinically significant prostate cancer prior to tissue biopsy.
The first patients were enrolled into this study in Q1, 2023, with headline results expected in 2024. Compelling data from the DOMINO study could form the basis of a laboratory developed test (LDT) which ANGLE would offer from its clinical laboratories in the US and the UK.
MidLantic Urology, an affiliate of Solaris Health Partners (Solaris), is one of the largest providers of specialist urology services in the US. The Solaris Health network encompasses more than 500 clinical urology providers across 179 locations and nine states treating ~730,000 patients annually.
For Research Use Only. Not For Use in Diagnostic Procedures.