The company has announced that the publication of the trial including 12,750 men has been fast tracked and is now published in The Lancet Oncology.
Results from the trial demonstrated that the combination of A3P Biomedical’s blood test Stockholm3 with Magnetic resonance imaging (MRI) in a population based prostate cancer screening program decreases unnecessary biopsies by 74% compared to standard of care, while maintaining detection of significant cancer.
“Decreases unnecessary biopsies by 74% compared to standard of care, while maintaining detection of significant cancer.”
Furthermore, Stockholm3 reduces MRI procedures with 36% compared to PSA. These significant improvements may enable population-based prostate cancer screening, states the company in a press release.
“To get fast track publication in The Lancet Oncology in addition to winning first prize for best abstract at the recent EAU 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 80,000 men,” says David Rosén, CEO, A3P Biomedical.
The STHLM3 MRI-trial
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% fewer unnecessary biopsy procedures and 69% fewer over-diagnosed 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, equalling a 27% improvement in AUC. Furthermore, by using Stockholm3 instead of PSA prior to MRI, the number of MRI procedures were reduced by 36% and the unnecessary biopsies were reduced an additional 18%.
Current standard of care starts with PSA testing. However, the poor specificity of PSA leads to unnecessary biopsies and over-diagnosis of low-grade prostate cancers, which has been a major barrier to the use of PSA in population-based screening, states the company in its press release.
“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% more aggressive cancers found, 50% reduction of unnecessary biopsies and 17 to 25% 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,”says Rosén.
Photo of David Rosén, CEO, A3P Biomedical