Fast track publication of the STHLM3 MRI trial in The Lancet Oncology
August 13, 2021
Stockholm3 in combination with MRI enables implementation of population-based screening of prostate cancer
The combination decreases unnecessary biopsies by 74 percent
STOCKHOLM, August 13, 2021. A3P Biomedical AB today announced that the publication of the STHLM3 MRI trial including 12,750 men has been fast tracked and is now published in the renowned peer-reviewed scientific publication The Lancet Oncology(1).
Results from the STHLM3 MRI trial, published in The Lancet Oncology, demonstrated that the combination of A3P Biomedical’s proprietary blood test Stockholm3 with Magnetic resonance imaging (MRI) in a population based prostate cancer screening program decreases unnecessary biopsies by 74 percent compared to standard of care, while maintaining detection of significant cancer.
Furthermore, Stockholm3 reduces MRI procedures with 36 percent compared to PSA. These significant improvements may enable population-based prostate cancer screening.
“To get fast track publication in The Lancet Oncology in addition to winning first prize for best abstract at the recent EAU(2) congress shows the significance of the data. A considerable reduction in unnecessary biopsies as well as MRI procedures, which creates bottlenecks, is a major improvement and provides the basis for accelerating the implementation of general prostate cancer screening. The evidence for the Stockholm3 test is based on clinical trials on more than 75,000 men”, said David Rosén, CEO at A3P Biomedical.
The STHLM3 MRI-trial is a randomized screening-by-invitation trial, comparing the standard test PSA with the Stockholm3 blood test when used with MRI-targeted or systematic biopsies for prostate cancer detection. 12,750 men in the age of 50-74 years participated in the trial. Compared to standard screening by PSA and systematic biopsies, Stockholm3 combined with MRI-targeted biopsies was associated with 74 percent fewer unnecessary biopsy procedures and 69 percent fewer overdiagnosed low-grade cancers, while maintaining detection of significant cancer.
The AUC (area under the receiver-operating characteristic curve) for significant cancer in the standard biopsy arm was 0.76 (95%CI 0.72-0.80) and 0.60 (95%CI 0.54-0.65) for Stockholm3 and PSA, respectively, equaling a 27 percent improvement in AUC. Furthermore, by using Stockholm3 instead of PSA prior to MRI, the number of MRI procedures were reduced by 36 percent and the unnecessary biopsies were reduced an additional 18 percent.
Current standard of care starts with PSA testing. However, the poor specificity of PSA leads to unnecessary biopsies and overdiagnosis of low-grade prostate cancers, which has been a major barrier to the use of PSA in population-based screening.
“The healthcare providers in the Nordics that already transitioned to Stockholm3 have demonstrated that in clinical practice even better results are achieved than in clinical screening trials; 100 percent more aggressive cancers found, 50 percent reduction of unnecessary biopsies and 17 to 25 percent lower costs. A3P Biomedical is committed to making the Stockholm3 test available worldwide and look forward to work with current and new partners to improve men’s health and quality of life”, David Rosén further commented.
About A3P Biomedical
A3P Biomedical is a company that specializes in advanced prostate cancer diagnostics. A3P’s main product, Stockholm3, is a clinically and commercially validated blood test for early detection and risk stratification of aggressive prostate cancer. A3P Biomedical is headquartered in Stockholm, Sweden. For more information, please visit www.a3p.com
About Stockholm3
Stockholm3 is a blood-based test, that runs a combination of protein biomarkers, genetic biomarkers and clinical information through an algorithm to find the probability of clinically significant cancer at biopsy.
Stockholm3 has been evaluated in clinical studies including more than 90,000 men. It is extensively tested in large population-based screening trials, as well as in real world clinical utility studies in primary care, as a reflex test to PSA at values 1.5-20 ng/ml. Benefits include the ability to reduce unnecessary MRIs, benign and Grade Group 1 prostate biopsies for men with elevated PSA, while simultaneously improving detection of clinically significant cancers in men with low or normal PSA values. Using Stockholm3 leads to a more accurate risk assessment than the current PSA standard. Stockholm3 detects 40-90% more men with aggressive prostate cancer and, at the same time, reduces over-detection by 40-50% compared to PSA.
Multiple Stockholm3 studies have been published in high-impact journals such as The Lancet Oncology, Journal of Clinical Oncology, and European Urology. The studies address both the specificity and sensitivity of Stockholm3 in multi-ethnic populations as well as health-economic benefits of implementing it in clinical care. For more information about our clinical studies please visit www.a3p.com.
About prostate cancer
Prostate cancer is the most common cancer in men. In 2020, the global incidence of new prostate cancer cases was 1.4 million, and prostate cancer specific mortality 370,000. Global prostate cancer incidence and mortality is expected to rise by 100% and 85% respectively by 2040, driven by an ageing population.
Press contact:
Cecilia Edström
cecilia.edstrom@a3p.com
+46 72 226 2328