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SEPTA
SEPTA Trial: Stockholm3 Validation Study in a Multi-Ethnic Cohort for ProsTAte Cancer
Sponsor study identifier
observational
2,152
2 countries
14
Study Start
December 15, 2019
Actual (reported)Primary Completion
July 15, 2023
Actual (reported)Study Completion
July 15, 2023
Actual (reported)Introduction: Prostate cancer (PCa) is the most commonly detected cancer in men and is the second leading cause of cancer death. Differences in race and ethnicity have been shown to have differences in PCa incidence, detection, and outcomes. Current prostate cancer screening involves prostatic specific antigen (PSA) which is a nonspecific protein marker (aka kallikrein) that can often leads to unnecessary biopsies (up to 74% benign biopsies) and clinical overdiagnosis (with up to 22% clinically insignificant cancer). Recently more sophisticated tests have been developed for PCa screening in the United States such as the Prostate Health Index (PHI) and the 4k (kallikrein) score, as well as clinical models that use information from the patient clinical history. However, these tests utilize limited serum protein assays and none of the established screening protocols utilize genetic variables to help account for the likely inherited risks as seen in different ethnicities. A recent Swedish, prospective, population-based study, published in the Lancet Oncology, developed a unique multivariable biopsy outcome prediction model within a Nordic population of nearly 60,000 men. This model, the Stockholm3, which incorporated plasma protein markers, germline DNA SNPs as well as clinical variables, was shown to be capable of reducing the number of biopsies by 44% compared to PSA while maintaining adequate sensitivity for detection of PCa. It is unknown whether an approach developed in Sweden that incorporates protein markers, genetics, clinical variables, and genetic ancestry would be beneficial in a racially diverse cohort. Hypothesis: The investigators hypothesize that, a prospectively studied multiethnic cohort of men with the Stockholm3 test will identify unique and common risk factors that improve prostate cancer detection. Aim: To assess the performance of the Stockholm3 test as compared to PSA and to identify unique features associated with PCa in Black/African American (n=500), Asian (n=500), White/Caucasian Hispanic (n=500), and White/Caucasian Non-Hispanic (n=500) men. Methods: The investigators propose a prospectively identified cohort with participating institutions which have screened positive to undergo a prostate biopsy to have a retrospective analysis the Stockholm3 test and ancestry markers. Within this cohort the investigators will examine several predetermined risk factors to investigate their relationship to prostate cancer. This blood sample will be tested for quantitative levels of serum protein markers and DNA will be extracted and will be tested for germline mutations as defined by the Stockholm3 test and other ancestry informative markers. Results from the study will be presented in such a way that no individual information will be disclosed.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
July 15, 2023
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
December 15, 2019
Actual (reported)September 28, 2020
Actual (reported)October 12, 2020
Actual (reported)July 15, 2023
Actual (reported)July 15, 2023
Actual (reported)Gleason Grade Group 2 Prostate Cancer
International Society of Urological Pathology Gleason Grade Group 2 Prostate Cancer. Gleason Grade Group scale is used to grade prostate cancer if found on a scale from 1 to 5. A higher score means a worse outcome.
On prostate biopsy immediately following PSA
National Comprehensive Cancer Network (NCCN) unfavorable intermediate risk prostate cancer or higher risk
On prostate biopsy immediately following PSA
Self-identified as White Non-Hispanic men, with age range (45.0 - 75.0 years), without prior evidence of prostate cancer
Self-identified as African or Black men, with age range (45.0 - 75.0 years), without prior evidence of prostate cancer
Self-identified as White Hispanic men, with age range (45.0 - 75.0 years), without prior evidence of prostate cancer
Self-identified as Asian men, with age range (45.0 - 75.0 years), without prior evidence of prostate cancer
Venipuncture: Prior to the biopsy the blood will be collected in 2 EDTA (lavender top) x 4 ml tubes will be removed after obtaining consent from the subjects.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
The subjects will be consented for prostate biopsy as part of standard of care. No additional advertising will be used for enrollment. Patients will be identified in clinic which meet the above inclusion criteria for prostate biopsy as part of routine practice. Enrollment will start from date of IRB approval and continue until study enrollment goal. Study enrollment goal will be 2,000 men who have a self-described race/ethnicity of: African/Black (n=500), Asian (n=500), Hispanic White/Caucasian (n=500), and Non-Hispanic White/Caucasian (n=500) men.
Los Angeles County
Los Angeles, California, 90033, United States
University of Southern California
Los Angeles, California, 90033, United States
Stanford University
Palo Alto, California, 94304, United States
Northwestern Medicine
Chicago, Illinois, 60611, United States
John H. Stroger, Jr. Hospital of Cook County
Chicago, Illinois, 60612, United States
Rush University Medical Center
Chicago, Illinois, 60612, United States
University of Illinois at Chicago
Chicago, Illinois, 60612, United States
Kasivisvanathan V, Rannikko AS, Borghi M, Panebianco V, Mynderse LA, Vaarala MH, Briganti A, Budaus L, Hellawell G, Hindley RG, Roobol MJ, Eggener S, Ghei M, Villers A, Bladou F, Villeirs GM, Virdi J, Boxler S, Robert G, Singh PB, Venderink W, Hadaschik BA, Ruffion A, Hu JC, Margolis D, Crouzet S, Klotz L, Taneja SS, Pinto P, Gill I, Allen C, Giganti F, Freeman A, Morris S, Punwani S, Williams NR, Brew-Graves C, Deeks J, Takwoingi Y, Emberton M, Moore CM; PRECISION Study Group Collaborators. MRI-Targeted or Standard Biopsy for Prostate-Cancer Diagnosis. N Engl J Med. 2018 May 10;378(19):1767-1777. doi: 10.1056/NEJMoa1801993. Epub 2018 Mar 18.
Gronberg H, Adolfsson J, Aly M, Nordstrom T, Wiklund P, Brandberg Y, Thompson J, Wiklund F, Lindberg J, Clements M, Egevad L, Eklund M. Prostate cancer screening in men aged 50-69 years (STHLM3): a prospective population-based diagnostic study. Lancet Oncol. 2015 Dec;16(16):1667-76. doi: 10.1016/S1470-2045(15)00361-7. Epub 2015 Nov 10.
Venipuncture: Prior to the biopsy the blood will be collected in 2 EDTA (lavender top) x 4 milliliters (8 milliliters total) tubes will be removed after obtaining consent from the subjects. One tube will be immediately centrifuged (10 minutes at 2000G) and plasma decanted to a tube without additives (this typically produces approximately 1.5 milliliters of plasma). The decanted tube (with plasma) and the remaining EDTA tube (with whole blood) is then frozen and stored at -20 degrees Celsius until being shipped to the A3P lab for Stockholm3 testing and analysis at -20 degrees Celsius (unless processing for DNA extraction and plasma analysis). Other biobanked specimens (as described in the Study detailed description) will be collected prospectively and will include plasma and Buffy Coat (used for DNA extraction) utilising the study inclusion and exclusion criteria.
Henrik Grönberg, MD, PhD
Karolinska Institutet
2,152 participants (actual enrollment reported by the registry).
First Submitted
September 28, 2020
First Posted
October 12, 2020
Study Start
December 15, 2019
Actual (reported)Contact the study team to confirm eligibility.
Cook County Health System
Chicago, Illinois, 60615, United States
University of Chicago
Chicago, Illinois, 60637, United States
Uropartners
Westchester, Illinois, 60154, United States
Montefiore Medical Center
The Bronx, New York, 10467, United States
Urology Clinics of North Texas
Dallas, Texas, 75231, United States
University of Texas Health Science Center San Antonio
San Antonio, Texas, 78229, United States
University Health Network
Toronto, Ontario, Canada
Strom P, Nordstrom T, Aly M, Egevad L, Gronberg H, Eklund M. The Stockholm-3 Model for Prostate Cancer Detection: Algorithm Update, Biomarker Contribution, and Reflex Test Potential. Eur Urol. 2018 Aug;74(2):204-210. doi: 10.1016/j.eururo.2017.12.028. Epub 2018 Jan 10.
Moller A, Olsson H, Gronberg H, Eklund M, Aly M, Nordstrom T. The Stockholm3 blood-test predicts clinically-significant cancer on biopsy: independent validation in a multi-center community cohort. Prostate Cancer Prostatic Dis. 2019 Mar;22(1):137-142. doi: 10.1038/s41391-018-0082-5. Epub 2018 Aug 31.
Vigneswaran HT, Discacciati A, Gann PH, Gronberg H, Eklund M, Abern MR. Ethnic variation in prostate cancer detection: a feasibility study for use of the Stockholm3 test in a multiethnic U.S. cohort. Prostate Cancer Prostatic Dis. 2021 Mar;24(1):120-127. doi: 10.1038/s41391-020-0250-2. Epub 2020 Jul 8.
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Potts JM, Lutz M, Walker E, Modlin C, Klein E. Trends in PSA, age and prostate cancer detection among black and white men from 1990-2006 at a tertiary care center. Cancer. 2010 Aug 15;116(16):3910-5. doi: 10.1002/cncr.25124.
Moyer VA; U.S. Preventive Services Task Force. Screening for prostate cancer: U.S. Preventive Services Task Force recommendation statement. Ann Intern Med. 2012 Jul 17;157(2):120-34. doi: 10.7326/0003-4819-157-2-201207170-00459.
Parekh DJ, Punnen S, Sjoberg DD, Asroff SW, Bailen JL, Cochran JS, Concepcion R, David RD, Deck KB, Dumbadze I, Gambla M, Grable MS, Henderson RJ, Karsh L, Krisch EB, Langford TD, Lin DW, McGee SM, Munoz JJ, Pieczonka CM, Rieger-Christ K, Saltzstein DR, Scott JW, Shore ND, Sieber PR, Waldmann TM, Wolk FN, Zappala SM. A multi-institutional prospective trial in the USA confirms that the 4Kscore accurately identifies men with high-grade prostate cancer. Eur Urol. 2015 Sep;68(3):464-70. doi: 10.1016/j.eururo.2014.10.021. Epub 2014 Oct 27.
de la Calle C, Patil D, Wei JT, Scherr DS, Sokoll L, Chan DW, Siddiqui J, Mosquera JM, Rubin MA, Sanda MG. Multicenter Evaluation of the Prostate Health Index to Detect Aggressive Prostate Cancer in Biopsy Naive Men. J Urol. 2015 Jul;194(1):65-72. doi: 10.1016/j.juro.2015.01.091. Epub 2015 Jan 28.
Roobol MJ, Verbeek JFM, van der Kwast T, Kummerlin IP, Kweldam CF, van Leenders GJLH. Improving the Rotterdam European Randomized Study of Screening for Prostate Cancer Risk Calculator for Initial Prostate Biopsy by Incorporating the 2014 International Society of Urological Pathology Gleason Grading and Cribriform growth. Eur Urol. 2017 Jul;72(1):45-51. doi: 10.1016/j.eururo.2017.01.033. Epub 2017 Feb 2.
Ankerst DP, Straubinger J, Selig K, Guerrios L, De Hoedt A, Hernandez J, Liss MA, Leach RJ, Freedland SJ, Kattan MW, Nam R, Haese A, Montorsi F, Boorjian SA, Cooperberg MR, Poyet C, Vertosick E, Vickers AJ. A Contemporary Prostate Biopsy Risk Calculator Based on Multiple Heterogeneous Cohorts. Eur Urol. 2018 Aug;74(2):197-203. doi: 10.1016/j.eururo.2018.05.003. Epub 2018 May 16.
Ankerst DP, Hoefler J, Bock S, Goodman PJ, Vickers A, Hernandez J, Sokoll LJ, Sanda MG, Wei JT, Leach RJ, Thompson IM. Prostate Cancer Prevention Trial risk calculator 2.0 for the prediction of low- vs high-grade prostate cancer. Urology. 2014 Jun;83(6):1362-7. doi: 10.1016/j.urology.2014.02.035.
Lichtenstein P, Holm NV, Verkasalo PK, Iliadou A, Kaprio J, Koskenvuo M, Pukkala E, Skytthe A, Hemminki K. Environmental and heritable factors in the causation of cancer--analyses of cohorts of twins from Sweden, Denmark, and Finland. N Engl J Med. 2000 Jul 13;343(2):78-85. doi: 10.1056/NEJM200007133430201.
Gronberg H, Eklund M, Picker W, Aly M, Jaderling F, Adolfsson J, Landquist M, Haug ES, Strom P, Carlsson S, Nordstrom T. Prostate Cancer Diagnostics Using a Combination of the Stockholm3 Blood Test and Multiparametric Magnetic Resonance Imaging. Eur Urol. 2018 Dec;74(6):722-728. doi: 10.1016/j.eururo.2018.06.022. Epub 2018 Jul 9.
Carroll PH, Mohler JL. NCCN Guidelines Updates: Prostate Cancer and Prostate Cancer Early Detection. J Natl Compr Canc Netw. 2018 May;16(5S):620-623. doi: 10.6004/jnccn.2018.0036.
Pepe MS, Alonzo TA. Comparing disease screening tests when true disease status is ascertained only for screen positives. Biostatistics. 2001 Sep;2(3):249-60. doi: 10.1093/biostatistics/2.3.249.
Lazarovich A, Vigneswaran H, Palsdottir T, Eklund M, Discacciati A, Nordstrom T, Hubbard RA, Perlis N, Abern MR, Moreira DM, Yonover P, Chow AK, Watts K, Liss MA, Thoreson GR, Abreu AL, Sonn GA, Plym A, Wiklund F, Gronberg H, Murphy AB, Eggener S. A Comparison of Stockholm3, Serum Biomarkers, and Risk Calculators to Predict Prostate Cancer in a Racially and Ethnically Diverse Cohort: Evaluation of the Stockholm3 Multiethnic SEPTA Trial. J Urol. 2025 May;213(5):590-599. doi: 10.1097/JU.0000000000004437. Epub 2025 Apr 9.
Vigneswaran HT, Eklund M, Discacciati A, Nordstrom T, Hubbard RA, Perlis N, Abern MR, Moreira DM, Eggener S, Yonover P, Chow AK, Watts K, Liss MA, Thoreson GR, Abreu AL, Sonn GA, Palsdottir T, Plym A, Wiklund F, Gronberg H, Murphy AB; SEPTA STHLM3 Study Group. Stockholm3 in a Multiethnic Cohort for Prostate Cancer Detection (SEPTA): A Prospective Multicentered Trial. J Clin Oncol. 2024 Nov 10;42(32):3806-3816. doi: 10.1200/JCO.24.00152. Epub 2024 Jul 22.
Primary Completion
July 15, 2023
Actual (reported)Study Completion
July 15, 2023
Actual (reported)Last Updated
October 21, 2024
Record last verified: 2024-10
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