Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
Recruitment Status
COMPLETED
Total Enrollment
2152 participants
Study Classification
OBSERVATIONAL
Study Start Date
2019-12-15
Study Completion Date
2023-07-15
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
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.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
From PSA to Stockholm3: Study Part 1
NCT03381105
Prostate Cancer
ACTIVE_NOT_RECRUITING
STHLM3 - Prostate Cancer Diagnostic Trial
NCT03639649
Prostate Cancer
COMPLETED
NA
Targeted Treatment for Metastatic Prostate Cancer, The PREDICT Trial
NCT06632977
Castration-Resistant Prostate Carcinoma
Stage IVB Prostate Cancer AJCC v8
RECRUITING
PHASE2
A Study of GSK5458514 Administered Alone or In Combination With Other Anti-Cancer Agents in Participants With Prostate Cancer
NCT06990880
Neoplasms, Prostate
RECRUITING
PHASE1/PHASE2
Supraphysiological Androgen to Enhance Treatment Activity in Metastatic Castration-Resistant Prostate Cancer, SPECTRA Study
NCT06039371
Castration-Resistant Prostate Carcinoma
Metastatic Prostate Adenocarcinoma
Stage IVB Prostate Cancer AJCC v8
RECRUITING
PHASE2
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Study Design and Procedures:
The research coordinator will explain the information contained within the consent. Additionally, patient's blood will be drawn prior to their biopsy.
Prior to the biopsy, blood will be collected in x2 ethylenediaminetetraacetic acid (EDTA) 4 ml tubes 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 1.5 ml of plasma). The decanted tube (with plasma) and the remaining EDTA tube (with whole blood) is then frozen and stored at the designated participating institutional site. It will be stored at -20 Celsius until being shipped. The SEPTA specific blood collection is followed by the following collaborators: Uropartners, University of Illinois at Chicago, University of Chicago, Rush Medical Center, Montefiore, University of Texas Health Science Center of San Antonio, Urology Clinics of North Texas, University of Southern California Keck School of Medicine, Los Angeles County Hospital, Stanford University.
Additional samples from University Health Network (Toronto), Northwestern Medicine, John H. Stroger, Jr. Hospital of Cook County, and Cook County Health System (Chicago) will be included from biobanked sources which were prospective collected meeting inclusion and exclusion criteria.
Patient data will be stored in a REDCap database, hosted on Sweden's secure server. Data will be stored for the duration of the study, and 5 years afterwards for data analysis purposes.
Consented patients will be tracked by patient logs by each participating institution. The medical record number will be collected to keep a consistent identifier for data collection by key site personnel. Once all the patient data is recorded the data will be exported from REDCap with the MRN removed. There will be no patient identifiers used at the Karolinska Institute or A3P lab. The following PHI and non-PHI information will be logged of the patient:
PHI:
Medical record number (MRN)
Non-PHI Demographic data
* Stockholm3 Identification number
* Race
* Zip code
Clinical data
* Total PSA
* Age on sampling date \[years\]
* Family history of prostate cancer
* Use of 5-alpha reductase inhibitors
* Earlier biopsy conducted
* Prostate volume \[Prostate volume as measure with US\]
* Digital rectal exam status \[Benign/normal, Nodule/induration felt, Asymmetry, Not performed\]
AND
Outcome data - Results from biopsy performed immediately after blood venipuncture, i.e.:
Results will be separated into targeted biopsy cores and systematic biopsy cores
* Gleason Score 1
* Gleason Score 2
* Gleason Sum
* Cancer length (mm) (total and highest grade)
* Number of cores
* Number of positive cores
* Time to perform biopsy after blood draw \[days\]
* Results from MRI, i.e. Prostate Imaging Reporting \& Data System (PIRADS) (0, 1, 2, 3, 4, 5)
Permitted use:
To run the Stockholm3 test defined by Gronberg et al AND Ancestry informative genetic markers
Samples will be shipped to the Uppsala based laboratory (A23 Laboratory) in Sweden for analysis. Each patient will have two blood samples (plasma and whole blood) and will be frozen at -20 Celsius. The blood samples will then be tested for quantitative levels of serum protein levels and DNA will be extracted from white blood cells and will be tested for gene and small nucleotide polymorphic (SNPs) germline mutations and variants .
Genotyping will be performed using custom genotyping assays. Plasma will be used for protein analysis. Plasma protein analysis will be performed using a custom protein assays including total and free PSA, human glandular kallikrein 2 (hK2), microseminoprotein-beta (MSMB), and Macrophage inhibitory cytokine 1 (MIC-1). PSA will be tested with a commercial assay.
Based on the results from the plasma protein analysis, the genetic analysis and clinical data, the Stockholm3 Risk Score will be calculated. The participants' samples will be treated in accordance with the regulations of Sweden at the laboratory based in Uppsala, Sweden.
Results of the tests will not be shared with the patient, nor will the results change or impact medical decisions.
Expected Risks/Benefits
Anticipated Risks:
As this is retrospective analysis of deidentified patient information as well as deidentified biospecimens, there are few anticipated risks. A confidentiality breach as well as loss of privacy are possible, however every effort will be made to minimize this risk.
Anticipated Benefits:
Participants will advance scientific and clinical knowledge. Participants will also receive a small payment for the time and involvement in the study.
Data Collection and Management Procedures
This study will utilize REDCap (Research Electronic Data Capture), a software toolset and workflow methodology for electronic collection and management of clinical and research data, to collect and store data. The Karolinska Institute Information Technology (KI-IT) Department will be used as a central location for data processing and management. REDCap is hosted by KI-IT in the Biomedicum (Solnavägen 9, Solna, Sweden 17165)
Data Analysis
Data analysis will be performed by the PI, co-investigators and/or key research personnel.
Quality Control and Quality Assurance
Key research personnel will be responsible for ensuring all data collected adheres to the protocol.
Data and Safety Monitoring
This study is minimal risk and all efforts will be made to ensure there are no confidentiality breaches as well as no loss of privacy.
Statistical Considerations
Power analysis This study is being conducted among several sites and thus pooled analysis will be performed. Based on the framework developed a two-sided alpha of 0.05, 250 men in each ethnicity gives 80% power to detect 10 percentage points differences in sensitivity and/or specificity of the Stockholm3 test across different ethnicities. Pooled data from several sites will allow for comparison between non-Hispanic White, Africa/Black, Asian, and Hispanic White men. Within each ethnicity group of 250 men, the same sample size gives a 90% power for detecting differences in area under curve (AUC) between Stockholm3 and PSA for detection of PC that are at least 10 percentage points (primary aim).
Goal accruement is 500 men within each race/ethnicity, interim analysis will be performed when 250 men in each race/ethnicity is enrolled.
Data Analysis Descriptive univariate statistics will be used to compare groups. Binary endpoints will be assessed with a logistic regression model. Statistical analysis will involve logistic regression modeling, AUC calculation, calibration analyses and calculation of basic performance characteristics (sensitivity, specificity and predictive values).
Regulatory Requirements
Informed Consent The participants indicate their consent to participate in the study by signing informed consents for accessing medical records, conducting genetic research and undergoing venipuncture for blood samples.
Subject Confidentiality Data used for this study will be stored in REDCaps and all data transferred between institutions will remain deidentified throughout the study.
Unanticipated Problems Any unanticipated problems will be immediately reported to the Site-specific ethical review board by designated research personnel.
The research coordinator will explain the information contained within the consent. Additionally, patient's blood will be drawn prior to their biopsy.
Prior to the biopsy, blood will be collected in x2 ethylenediaminetetraacetic acid (EDTA) 4 ml tubes 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 1.5 ml of plasma). The decanted tube (with plasma) and the remaining EDTA tube (with whole blood) is then frozen and stored at the designated participating institutional site. It will be stored at -20 Celsius until being shipped. The SEPTA specific blood collection is followed by the following collaborators: Uropartners, University of Illinois at Chicago, University of Chicago, Rush Medical Center, Montefiore, University of Texas Health Science Center of San Antonio, Urology Clinics of North Texas, University of Southern California Keck School of Medicine, Los Angeles County Hospital, Stanford University.
Additional samples from University Health Network (Toronto), Northwestern Medicine, John H. Stroger, Jr. Hospital of Cook County, and Cook County Health System (Chicago) will be included from biobanked sources which were prospective collected meeting inclusion and exclusion criteria.
Patient data will be stored in a REDCap database, hosted on Sweden's secure server. Data will be stored for the duration of the study, and 5 years afterwards for data analysis purposes.
Consented patients will be tracked by patient logs by each participating institution. The medical record number will be collected to keep a consistent identifier for data collection by key site personnel. Once all the patient data is recorded the data will be exported from REDCap with the MRN removed. There will be no patient identifiers used at the Karolinska Institute or A3P lab. The following PHI and non-PHI information will be logged of the patient:
PHI:
Medical record number (MRN)
Non-PHI Demographic data
* Stockholm3 Identification number
* Race
* Zip code
Clinical data
* Total PSA
* Age on sampling date \[years\]
* Family history of prostate cancer
* Use of 5-alpha reductase inhibitors
* Earlier biopsy conducted
* Prostate volume \[Prostate volume as measure with US\]
* Digital rectal exam status \[Benign/normal, Nodule/induration felt, Asymmetry, Not performed\]
AND
Outcome data - Results from biopsy performed immediately after blood venipuncture, i.e.:
Results will be separated into targeted biopsy cores and systematic biopsy cores
* Gleason Score 1
* Gleason Score 2
* Gleason Sum
* Cancer length (mm) (total and highest grade)
* Number of cores
* Number of positive cores
* Time to perform biopsy after blood draw \[days\]
* Results from MRI, i.e. Prostate Imaging Reporting \& Data System (PIRADS) (0, 1, 2, 3, 4, 5)
Permitted use:
To run the Stockholm3 test defined by Gronberg et al AND Ancestry informative genetic markers
Samples will be shipped to the Uppsala based laboratory (A23 Laboratory) in Sweden for analysis. Each patient will have two blood samples (plasma and whole blood) and will be frozen at -20 Celsius. The blood samples will then be tested for quantitative levels of serum protein levels and DNA will be extracted from white blood cells and will be tested for gene and small nucleotide polymorphic (SNPs) germline mutations and variants .
Genotyping will be performed using custom genotyping assays. Plasma will be used for protein analysis. Plasma protein analysis will be performed using a custom protein assays including total and free PSA, human glandular kallikrein 2 (hK2), microseminoprotein-beta (MSMB), and Macrophage inhibitory cytokine 1 (MIC-1). PSA will be tested with a commercial assay.
Based on the results from the plasma protein analysis, the genetic analysis and clinical data, the Stockholm3 Risk Score will be calculated. The participants' samples will be treated in accordance with the regulations of Sweden at the laboratory based in Uppsala, Sweden.
Results of the tests will not be shared with the patient, nor will the results change or impact medical decisions.
Expected Risks/Benefits
Anticipated Risks:
As this is retrospective analysis of deidentified patient information as well as deidentified biospecimens, there are few anticipated risks. A confidentiality breach as well as loss of privacy are possible, however every effort will be made to minimize this risk.
Anticipated Benefits:
Participants will advance scientific and clinical knowledge. Participants will also receive a small payment for the time and involvement in the study.
Data Collection and Management Procedures
This study will utilize REDCap (Research Electronic Data Capture), a software toolset and workflow methodology for electronic collection and management of clinical and research data, to collect and store data. The Karolinska Institute Information Technology (KI-IT) Department will be used as a central location for data processing and management. REDCap is hosted by KI-IT in the Biomedicum (Solnavägen 9, Solna, Sweden 17165)
Data Analysis
Data analysis will be performed by the PI, co-investigators and/or key research personnel.
Quality Control and Quality Assurance
Key research personnel will be responsible for ensuring all data collected adheres to the protocol.
Data and Safety Monitoring
This study is minimal risk and all efforts will be made to ensure there are no confidentiality breaches as well as no loss of privacy.
Statistical Considerations
Power analysis This study is being conducted among several sites and thus pooled analysis will be performed. Based on the framework developed a two-sided alpha of 0.05, 250 men in each ethnicity gives 80% power to detect 10 percentage points differences in sensitivity and/or specificity of the Stockholm3 test across different ethnicities. Pooled data from several sites will allow for comparison between non-Hispanic White, Africa/Black, Asian, and Hispanic White men. Within each ethnicity group of 250 men, the same sample size gives a 90% power for detecting differences in area under curve (AUC) between Stockholm3 and PSA for detection of PC that are at least 10 percentage points (primary aim).
Goal accruement is 500 men within each race/ethnicity, interim analysis will be performed when 250 men in each race/ethnicity is enrolled.
Data Analysis Descriptive univariate statistics will be used to compare groups. Binary endpoints will be assessed with a logistic regression model. Statistical analysis will involve logistic regression modeling, AUC calculation, calibration analyses and calculation of basic performance characteristics (sensitivity, specificity and predictive values).
Regulatory Requirements
Informed Consent The participants indicate their consent to participate in the study by signing informed consents for accessing medical records, conducting genetic research and undergoing venipuncture for blood samples.
Subject Confidentiality Data used for this study will be stored in REDCaps and all data transferred between institutions will remain deidentified throughout the study.
Unanticipated Problems Any unanticipated problems will be immediately reported to the Site-specific ethical review board by designated research personnel.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Prostate Cancer (Diagnosis)
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
Observational Model Type
COHORT
Study Time Perspective
PROSPECTIVE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Non-Hispanic/Latino White/Caucasian men
Self-identified as White Non-Hispanic men, with age range (45.0 - 75.0 years), without prior evidence of prostate cancer
The Stockholm3 test
Intervention Type
DIAGNOSTIC_TEST
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.
African/Black men
Self-identified as African or Black men, with age range (45.0 - 75.0 years), without prior evidence of prostate cancer
The Stockholm3 test
Intervention Type
DIAGNOSTIC_TEST
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.
Hispanic/Latino White/Caucasian men
Self-identified as White Hispanic men, with age range (45.0 - 75.0 years), without prior evidence of prostate cancer
The Stockholm3 test
Intervention Type
DIAGNOSTIC_TEST
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.
Asian men
Self-identified as Asian men, with age range (45.0 - 75.0 years), without prior evidence of prostate cancer
The Stockholm3 test
Intervention Type
DIAGNOSTIC_TEST
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.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
The Stockholm3 test
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.
Intervention Type
DIAGNOSTIC_TEST
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Diagnostic Test: Custom ancestry informative genetic markers
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* All men (age 45.0 - 75.0 years), regardless of race, presenting to a practicing urologist with symptoms that would lead to an evaluation for prostate cancer and who are scheduled to receive a needle biopsy of the prostate
* No prior diagnosis of prostate cancer
* No prior diagnosis of prostate cancer
Exclusion Criteria
* Men who in the three (3) months prior to study participation received any invasive urologic procedure such as biopsy, thermotherapy, microwave therapy, laser therapy, transurethral resection of the prostate (TURP), urethral catheterization, and lower genitourinary tract endoscopy (cystoscopy)
* Men who were subjected to DRE or prostate manipulation within five (5) days (120 hours) prior to blood sampling
* Men who were subjected to DRE or prostate manipulation within five (5) days (120 hours) prior to blood sampling
Minimum Eligible Age
45 Years
Maximum Eligible Age
75 Years
Eligible Sex
MALE
Accepts Healthy Volunteers
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
University of Illinois at Chicago
OTHER
Sponsor Role
collaborator
UroPartners
UNKNOWN
Sponsor Role
collaborator
University of Chicago
OTHER
Sponsor Role
collaborator
Rush University Medical Center
OTHER
Sponsor Role
collaborator
Montefiore Medical Center
OTHER
Sponsor Role
collaborator
The University of Texas Health Science Center at San Antonio
OTHER
Sponsor Role
collaborator
Cook County Health & Hospitals System
OTHER
Sponsor Role
collaborator
Cook County Health
OTHER_GOV
Sponsor Role
collaborator
Stanford University
OTHER
Sponsor Role
collaborator
Northwestern Medicine
OTHER
Sponsor Role
collaborator
University of Southern California
OTHER
Sponsor Role
collaborator
University Health Network, Toronto
OTHER
Sponsor Role
collaborator
Urology Clinics of North Texas
NETWORK
Sponsor Role
collaborator
LAC+USC Medical Center
OTHER
Sponsor Role
collaborator
Karolinska Institutet
OTHER
Sponsor Role
lead
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Henrik Grönberg
Professor
Responsibility Role
PRINCIPAL_INVESTIGATOR
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Henrik Grönberg, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Karolinska Institutet
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Los Angeles County
Los Angeles, California, United States
Site Status
University of Southern California
Los Angeles, California, United States
Site Status
Stanford University
Palo Alto, California, United States
Site Status
Northwestern Medicine
Chicago, Illinois, United States
Site Status
John H. Stroger, Jr. Hospital of Cook County
Chicago, Illinois, United States
Site Status
Rush University Medical Center
Chicago, Illinois, United States
Site Status
University of Illinois at Chicago
Chicago, Illinois, United States
Site Status
Cook County Health System
Chicago, Illinois, United States
Site Status
University of Chicago
Chicago, Illinois, United States
Site Status
Uropartners
Westchester, Illinois, United States
Site Status
Montefiore Medical Center
The Bronx, New York, United States
Site Status
Urology Clinics of North Texas
Dallas, Texas, United States
Site Status
University of Texas Health Science Center San Antonio
San Antonio, Texas, United States
Site Status
University Health Network
Toronto, Ontario, Canada
Site Status
Countries
Review the countries where the study has at least one active or historical site.
United States
Canada
References
Explore related publications, articles, or registry entries linked to this study.
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.
Reference Type
BACKGROUND
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.
Reference Type
BACKGROUND
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.
Reference Type
BACKGROUND
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.
Reference Type
BACKGROUND
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.
Reference Type
BACKGROUND
Siegel RL, Miller KD, Jemal A. Cancer statistics, 2018. CA Cancer J Clin. 2018 Jan;68(1):7-30. doi: 10.3322/caac.21442. Epub 2018 Jan 4.
Reference Type
BACKGROUND
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.
Reference Type
BACKGROUND
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.
Reference Type
BACKGROUND
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.
Reference Type
BACKGROUND
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.
Reference Type
BACKGROUND
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.
Reference Type
BACKGROUND
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.
Reference Type
BACKGROUND
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.
Reference Type
BACKGROUND
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.
Reference Type
BACKGROUND
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.
Reference Type
BACKGROUND
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.
Reference Type
BACKGROUND
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.
Reference Type
BACKGROUND
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.
Reference Type
DERIVED
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
KarolinskaI3
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.
Evaluation of Response to Abiraterone/Prednisone by Race/Ethnicity and Other Factors in Metastatic Hormone Naive Prostate Cancer
NCT03833921
RECRUITING
PHASE2
Follow-Up Study for Men Diagnosed With Prostate Cancer Through Participation in a Prostate Specific Antigen Screening Program
NCT00035217
COMPLETED
Ipatasertib Plus Abiraterone Plus Prednisone/Prednisolone, Relative to Placebo Plus Abiraterone Plus Prednisone/Prednisolone in Adult Male Patients With Metastatic Castrate-Resistant Prostate Cancer
NCT03072238
COMPLETED
PHASE3
Phase II Study of ASP3550 in Patients With Prostate Cancer
NCT00568516
COMPLETED
PHASE2
Apalutamide and Abiraterone Acetate in African American and Caucasian Men With Metastatic Castrate Resistant Prostate Cancer
NCT03098836
COMPLETED
PHASE2
Standard Systemic Therapy With or Without Definitive Treatment in Treating Participants With Metastatic Prostate Cancer
NCT03678025
RECRUITING
PHASE3
AZD0530 in Treating Patients With Prostate Cancer That Did Not Respond to Hormone Therapy
NCT00513071
COMPLETED
PHASE2
S1014 Abiraterone Acetate in Treating Patients With Prostate Cancer Who Have Undergone Initial Hormone Therapy
NCT01309672
COMPLETED
PHASE2
STHLM3 AS NorDCaP - a Followup Study of Men on Active Surveillance of Prostate Cancer
NCT04627948
COMPLETED
Systemic Therapy in Advancing or Metastatic Prostate Cancer: Evaluation of Drug Efficacy
NCT00268476
ACTIVE_NOT_RECRUITING
PHASE2/PHASE3
Sbrt±sTad for Unfavorable iNtermediate rIsk/High Risk Prostate caNcer
NCT05557604
RECRUITING
PHASE2
Testing the Addition of Docetaxel (Chemotherapy) to the Usual Treatment (Hormonal Therapy and Apalutamide) for Metastatic Prostate Cancer, ASPIRE Trial
NCT06931340
RECRUITING
PHASE3
Evaluation of Molecular Forms of PSA and Human Kallikrein 2 in a Cohort of Patients With Locally Resected Prostate Cancer But Biochemical Recurrence
NCT02070575
COMPLETED
Study of Tissue and Blood Samples From Patients With Recurrent Prostate Cancer Who Received Lapatinib on Clinical Trial ECOG-E5803
NCT00897351
COMPLETED
Observational Cohort Study of Patients With Castration-Resistant Prostate Cancer (CRPC)
NCT02380274
COMPLETED
Decision Impact Trial of the ExoDx Prostate (IntelliScore)
NCT03235687
UNKNOWN
NA
ProBio: A Biomarker Driven Study in Patients With Metastatic Prostate Cancer
NCT03903835
RECRUITING
PHASE3
A Phase 2 Study to Evaluate the Effects of ASP5541 in Participants With Prostate Cancer
NCT07005154
RECRUITING
PHASE2
Decision Aids in Improving Knowledge in Patients With Newly Diagnosed Prostate Cancer
NCT03103321
COMPLETED
PHASE3
Testing the Effect of M1774 on Hard-to-Treat Refractory SPOP-mutant Prostate Cancer
NCT05828082
ACTIVE_NOT_RECRUITING
PHASE2
Stereotactic Body Radiotherapy (SBRT) for Localized Prostate Cancer
NCT04489745
UNKNOWN
PHASE2
Hormone Therapy and Ipilimumab in Treating Patients With Advanced Prostate Cancer
NCT00170157
COMPLETED
PHASE2
Identification of Clinically Insignificant or Significant Prostate Cancer With the miR Scientific Sentinel™ Platform
NCT04100811
UNKNOWN
A Non-Interventional Study to Evaluate Time to Event and Healthcare Resource Utilisation for Prostate Cancer Participants Throughout the Disease Trajectories Until Progression or Death
NCT03619980
COMPLETED
S0032, Combination Chemotherapy Plus Hormone Therapy in Treating Patients With Metastatic Prostate Cancer
NCT00028769
COMPLETED
PHASE2