TEST:

Stockholm3

Use of the Stockholm3 test for repeated prostate cancer screening could reduce the need for MRI while maintaining detection rates for high-risk cancer.

"A3P Biomedical and Labor Dr. Wisplinghoff, one of Germany's largest and most renowned medical laboratories, are excited to announce that Stockholm3, for early detection of prostate cancer, has now been launched and is available in Germany."

"A3P Biomedical...has entered a strategic partnership with labor team...Effective November 1, 2024, this collaboration will make Stockholm3, a pioneering blood-based diagnostic for early detection of aggressive prostate cancer, available to men throughout Switzerland."

Complete omission of systematic biopsies in prostate cancer screening is associated with decreased detection of significant cancer, while reducing overdetection of insignificant cancer to a smaller extent. This strategy also increased the risk of histopathological misclassification.

No abstract available

"Stockholm3 has been independently, externally validated at the Martini Klinik, the world-renowned prostate cancer center in Hamburg, Germany. The Martini validation study demonstrated results consistent with previous Stockholm3 studies, achieving a 52 percent reduction of unnecessary biopsies."

P=N/A; N=500; Not yet recruiting; Sponsor:Karolinska Institutet

Stockholm3 utilization could detect 92% of clinically significant prostate cancer cases while simultaneously reducing unnecessary biopsies by 52%, compared with the PSA ≥3 ng/ml criterion, based on our analysis within a cohort of men who underwent systematic biopsies.

The combination of Stockholm3 and MRI proves effective in diagnosing prostate cancer during retesting. Notably, after two rounds of testing, Stockholm3 and MRI exhibit a high negative predictive value, with only 2.4% of participants diagnosed with clinically significant prostate cancer.Outcome TotalMen with two Stockholm3 tests 2018-2023, n (% of total tested in 1st round)499 (4%)Participants with elevated test results on Stockholm3 in 2nd testing round, n (% of men with 2 tests)105 (21%)MRI procedures performed at Capio PCC, n (% of tested men)105 (21%)PI-RADS 0-2 (n, % of men with MRI)84 (80%)PI-RADS ≥3 (n, % of men with MRI)21 (20%)Biopsy procedures, n (% of tested men)21 (4%)Benign biopsy, n (% of tested men)7 (1.4%)ISUP 1 prostate cancer, n (% of tested men)2 (0.5%)ISUP 2 prostate cancer, n (% of tested men)9 (2%)ISUP ≥3 prostate cancer, n (% of tested men)3 (0.6%)

Men with a normal Stockholm3 score despite cancer detected from an elevated PSA have a lower risk of biochemical recurrence compared to men with low PSA and elevated risk on Stockholm3.Figure 1: Cumulative incidence of biochemical recurrence in men that underwent radical prostectomy in the STHLM3 trial according to PSA and Stockholm3 test result before diagnosis.

"Findings from the SEPTA trial demonstrate the utility and generalizability of Stockholm3 in reducing unneeded biopsies and detecting prostate cancer (PCa) in Asian, Black, Hispanic, and White men, representing an important improvement in the harm-benefit tradeoffs in PCa detection."

In a substantially diverse population, Stockholm3 significantly reduces unnecessary prostate biopsies while maintaining a similar sensitivity to PSA in detecting csPC.

We explored different ways to detect prostate cancer more cost-effectively. We found that using a specific blood test, called Stockholm3, after a PSA (prostate-specific antigen) test to decide if an MRI scan (magnetic resonance imaging) is necessary could save money, mainly by identifying localized cancer earlier and reducing the need for expensive treatments for advanced cancer.

"A3P Biomedical AB...and BioAgilytix...are excited to announce that Stockholm3 for early detection of prostate cancer is now commercially available as a Lab Developed Test (LDT) throughout the United States."

"A recent study published in European Urology Open Science demonstrates that incorporating Stockholm3 into prostate cancer diagnostics can significantly reduce healthcare costs. Stockholm3, which combines genetic-, protein- and clinical markers, also provides a more accurate risk stratification for developing significant prostate cancer compared to PSA testing alone."

No abstract available

P=N/A; In regions where access to MRI is lacking, the Stockholm3 test can aid in selecting patients for systematic prostate biopsy. ClinicalTrials.gov Identifier: NCT03377881.

"The annual 2024 European Association of Urology (EAU) meeting was held in Paris from April 5 – 8. More sophisticated risk adapted prostate cancer strategies was a focus area, including six abstracts evaluating Stockholm3 in populations across Europe and North America. An abstract utilizing a baseline Stockholm3 score to predict biochemical recurrence after prostatectomy was awarded best abstract in the prostate cancer biopsy indication session."

This review found that a combination of approaches, centred on the use of pre-biopsy MRI, may improve the detection of clinically significant cancers and reduce (i) the diagnosis of clinically insignificant cancers and (ii) unnecessary biopsies, compared with PSA testing and standard biopsy alone. However, the impact of such interventions on longer term outcomes such as prostate cancer-specific mortality has not yet been assessed.

P=N/A; Trial completion date: Dec 2023 --> Dec 2024 | Trial primary completion date: Dec 2023 --> Jun 2024

"In 2002, Region Stockholm and Region Gotland (the Region) began a joint three-year project by offering organised prostate cancer testing (OPT) to all 50-year-old men living in the Region. In 2024, an evaluation of the Stockholm3 test will be made in a research project at Karolinska Institutet in collaboration with OPT."

This study underscores the effectiveness of the protocol-driven diagnostic process at Capio PCC, enabling earlier detection of intermediate-risk prostate cancer and reducing the need for MRI assessments compared with standard prostate cancer care in Sweden. At the Capio Prostate Cancer Center, a novel diagnostic approach incorporating prostate-specific antigen, Stockholm3, magnetic resonance imaging, and targeted biopsies has been implemented to enhance prostate cancer testing and diagnosis in Stockholm, Sweden.

"In the latest edition of European Urology Open Sciences, the Prostate Cancer Center at Capio St. Göran’s Hospital is highlighted for its well-invested and structured model for prostate cancer diagnostics. This model, based on Stockholm3 combined with MRI and targeted biopsies has been shown to significantly improve the diagnostic outcome and health economics."

No abstract available

"The primary results of the landmark SEPTA trial, with over 2,000 racially and ethnically diverse biopsied men recruited in the US and Canada, were presented...at the ASCO-GU (The American Society of Clinical Oncology – Genitourinary Cancer Symposium) conference in San Francisco on January 26. The study found that use of the blood-based biomarker Stockholm3 was more accurate and could avoid up to half of unnecessary biopsies compared to current clinical practice. The findings were similar across all racial and ethnic groups."

No abstracts available

No abstracts available

No abstracts available

The study demonstrates that the protocol-driven and diagnostic process at Capio PCC leads to an effective care, enabling earlier diagnosis of intermediate risk cancer and reducing the number of MRIs as well as incidence of overdiagnosis of low-risk cancers compared to the prostate cancer care in Sweden.

In an ethnically diverse population, Stockholm3 would significantly reduce unnecessary prostate biopsies and diagnosis of ISUP 1 cancer at a similar sensitivity of PSA for detecting clinically significant cancer. Clinical trial information: NCT04583072.

P=N/A; Recruiting --> Completed | Trial completion date: Oct 2022 --> Oct 2023

Our results show favorable clinical outcomes for the blood-based Stockholm3 biomarker test in a Central European patient cohort.

Systematic biopsies can be omitted in patients with a positive Stockholm3 test and a negative MRI when there is a volume cutoff in the test report. With no volume cutoff, biopsies can be considered with shared decision-making.

No abstract available

P=N/A, N=400, Recruiting, Karolinska Institutet | Trial primary completion date: Sep 2023 --> Dec 2023

No abstract available

"A3P Biomedical AB...and BioAgilytix, a global bioanalytical services provider, have entered a partnership with the aim of introducing Stockholm3, as a Lab Developed Test (LDT) designed to redefine the standard of care for early detection of prostate cancer in the USA."