Stockholm3 Validation Study in a Multi-Ethnic Cohort (SEPTA)
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ClinicalTrials.gov Identifier: NCT04583072 |
Recruitment Status :
Completed
First Posted : October 12, 2020
Last Update Posted : September 13, 2023
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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.
Condition or disease | Intervention/treatment |
---|---|
Prostate Cancer (Diagnosis) | Diagnostic Test: The Stockholm3 test |
Study Type : | Observational |
Actual Enrollment : | 2152 participants |
Observational Model: | Cohort |
Time Perspective: | Prospective |
Official Title: | SEPTA Trial: Stockholm3 Validation Study in a Multi-Ethnic Cohort for ProsTAte Cancer |
Actual Study Start Date : | December 15, 2019 |
Actual Primary Completion Date : | July 15, 2023 |
Actual Study Completion Date : | July 15, 2023 |
Group/Cohort | Intervention/treatment |
---|---|
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
|
Diagnostic Test: 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.
Other Name: Diagnostic Test: Custom ancestry informative genetic markers |
African/Black men
Self-identified as African or Black men, with age range (45.0 - 75.0 years), without prior evidence of prostate cancer
|
Diagnostic Test: 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.
Other Name: Diagnostic Test: Custom ancestry informative genetic markers |
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
|
Diagnostic Test: 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.
Other Name: Diagnostic Test: Custom ancestry informative genetic markers |
Asian men
Self-identified as Asian men, with age range (45.0 - 75.0 years), without prior evidence of prostate cancer
|
Diagnostic Test: 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.
Other Name: Diagnostic Test: Custom ancestry informative genetic markers |
- Gleason Grade Group 2 Prostate Cancer [ Time Frame: On prostate biopsy immediately following PSA ]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.
- National Comprehensive Cancer Network (NCCN) unfavorable intermediate risk prostate cancer or higher risk [ Time Frame: On prostate biopsy immediately following PSA ]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
Biospecimen Retention: Samples With DNA
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.
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Ages Eligible for Study: | 45 Years to 75 Years (Adult, Older Adult) |
Sexes Eligible for Study: | Male |
Gender Based Eligibility: | Yes |
Gender Eligibility Description: | Biologic XY sex |
Sampling Method: | Probability Sample |
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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04583072
United States, California | |
Los Angeles County | |
Los Angeles, California, United States, 90033 | |
University of Southern California | |
Los Angeles, California, United States, 90033 | |
Stanford University | |
Palo Alto, California, United States, 94304 | |
United States, Illinois | |
Northwestern Medicine | |
Chicago, Illinois, United States, 60611 | |
John H. Stroger, Jr. Hospital of Cook County | |
Chicago, Illinois, United States, 60612 | |
Rush University Medical Center | |
Chicago, Illinois, United States, 60612 | |
University of Illinois at Chicago | |
Chicago, Illinois, United States, 60612 | |
Cook County Health System | |
Chicago, Illinois, United States, 60615 | |
University of Chicago | |
Chicago, Illinois, United States, 60637 | |
Uropartners | |
Westchester, Illinois, United States, 60154 | |
United States, New York | |
Montefiore Medical Center | |
Bronx, New York, United States, 10467 | |
United States, Texas | |
Urology Clinics of North Texas | |
Dallas, Texas, United States, 75231 | |
University of Texas Health Science Center San Antonio | |
San Antonio, Texas, United States, 78229 | |
Canada, Ontario | |
University Health Network | |
Toronto, Ontario, Canada |
Principal Investigator: | Henrik Grönberg, MD, PhD | Karolinska Institutet |
Responsible Party: | Henrik Grönberg, Professor, Karolinska Institutet |
ClinicalTrials.gov Identifier: | NCT04583072 |
Other Study ID Numbers: |
KarolinskaI3 |
First Posted: | October 12, 2020 Key Record Dates |
Last Update Posted: | September 13, 2023 |
Last Verified: | January 2023 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Prostatic Neoplasms Neoplasms Genital Neoplasms, Male Urogenital Neoplasms Neoplasms by Site |
Genital Diseases, Male Genital Diseases Urogenital Diseases Prostatic Diseases Male Urogenital Diseases |