Prostate Cancer (Diagnosis) Clinical Trial
— SEPTAOfficial title:
SEPTA Trial: Stockholm3 Validation Study in a Multi-Ethnic Cohort for ProsTAte Cancer
Verified date | January 2023 |
Source | Karolinska Institutet |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Completed |
Enrollment | 2152 |
Est. completion date | July 15, 2023 |
Est. primary completion date | July 15, 2023 |
Accepts healthy volunteers | |
Gender | Male |
Age group | 45 Years to 75 Years |
Eligibility | 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 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 |
Country | Name | City | State |
---|---|---|---|
Canada | University Health Network | Toronto | Ontario |
United States | Montefiore Medical Center | Bronx | New York |
United States | Cook County Health System | Chicago | Illinois |
United States | John H. Stroger, Jr. Hospital of Cook County | Chicago | Illinois |
United States | Northwestern Medicine | Chicago | Illinois |
United States | Rush University Medical Center | Chicago | Illinois |
United States | University of Chicago | Chicago | Illinois |
United States | University of Illinois at Chicago | Chicago | Illinois |
United States | Urology Clinics of North Texas | Dallas | Texas |
United States | Los Angeles County | Los Angeles | California |
United States | University of Southern California | Los Angeles | California |
United States | Stanford University | Palo Alto | California |
United States | University of Texas Health Science Center San Antonio | San Antonio | Texas |
United States | Uropartners | Westchester | Illinois |
Lead Sponsor | Collaborator |
---|---|
Karolinska Institutet | Cook County Health, Cook County Health & Hospitals System, LAC+USC Medical Center, Montefiore Medical Center, Northwestern Medicine, Rush University Medical Center, Stanford University, The University of Texas Health Science Center at San Antonio, University Health Network, Toronto, University of Chicago, University of Illinois at Chicago, University of Southern California, Urology Clinics of North Texas, UroPartners |
United States, Canada,
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* Note: There are 17 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Secondary | National Comprehensive Cancer Network (NCCN) unfavorable intermediate risk prostate cancer or higher risk | National Comprehensive Cancer Network Unfavorable intermediate risk prostate cancer or higher risk. National Comprehensive Cancer Network risk stratification scores range from very low risk, low risk, intermediate risk, high risk and very high risk. Intermediate risk is stratified into favorable intermediate risk and unfavorable intermediate risk. The higher the risk the worse the outcome | On prostate biopsy immediately following PSA |
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