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Trial Title:
Stockholm3 Use Prior to MRI for Prostate Cancer Detection in a Clinical Care Pathway: a Multi-centered Validation
NCT ID:
NCT06573736
Condition:
Prostate Cancer
Conditions: Official terms:
Prostatic Neoplasms
Study type:
Observational
Overall status:
Not yet recruiting
Study design:
Time perspective:
Prospective
Intervention:
Intervention type:
Diagnostic Test
Intervention name:
Stockholm3
Description:
Stockholm3 combines protein markers tPSA, fPSA, KLK2, PSP94 and GDF15, genetic markers
and clinical data to estimate risk for clinically significant prostate cancer.
Summary:
Men meeting local clinical standard of care to undergo a prostate MRI for suspicion of
prostate cancer will be included. Blood sample will be drawn on the day of MRI or
immediately prior to MRI for measurement of the prostate cancer biomarker Stockholm3.
Specifically, the Stockholm3 test will be performed in a retrospective manner and no
clinical decisions will be made based on the results. The patients will not receive the
results of the Stockholm3 assay. A Stockholm3 score will be reported for each patient.
The primary aim is to show superior specificity of Stockholm3 (at different thresholds)
for MRI selection compared to PSA (at different thresholds) (I.e., the proportion of men
with a negative Stockholm3 test or a negative PSA test among those with a normal MRI).
Additional aims:
1. To show non-inferior relative sensitivity in detection of csPC of Stockholm3
compared to PSA (The proportion of men with a positive Stockholm3 test (at different
thresholds) or a positive PSA test (at different thresholds) among those diagnosed
with csPC will be calculated).
2. To evaluate Stockholm3 risk thresholds to determine if it can be used to further
reduce MRI, biopsy and Gleason grade group 1 cancers without reducing sensitivity of
csPC detection.
Criteria for eligibility:
Study pop:
Men meeting local standard of care to undergo prostate MRI for suspicion of prostate
cancer
Sampling method:
Probability Sample
Criteria:
Inclusion Criteria:
- Men with age range (40.0 - 80.0 years)
- Already scheduled to undergo MRI for prostate cancer screening (both negative and
positive MRI included).
Exclusion Criteria:
- PSA < 1.5 ng/mL
- Any known diagnosis of prostate cancer (patient on active surveillance)
- Men that have undergone digital rectal exam (DRE) immediately before blood draw (DRE
within 5 days of study blood draw are excluded).
- Men who in the three (3) months prior to study participation received any invasive
urologic procedure such as thermotherapy, microwave therapy, laser therapy,
transurethral resection of the prostate (TURP), urethral catheterization, and lower
genitourinary tract endoscopy (cystoscopy)
- No history of new treatment for BPH in three (3) months prior to study
participation.
Gender:
Male
Minimum age:
40 Years
Maximum age:
80 Years
Healthy volunteers:
Accepts Healthy Volunteers
Start date:
October 1, 2024
Completion date:
December 31, 2025
Lead sponsor:
Agency:
Karolinska Institutet
Agency class:
Other
Source:
Karolinska Institutet
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06573736
