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Not yet recruitingNCT06573736S3M-MRIUpdated Aug 27, 2024

Stockholm3 Use Prior to MRI for Prostate Cancer Detection in a Clinical Care Pathway: a Multi-centered Validation

An observational study in Prostate Cancer, sponsored by Karolinska Institutet. Not yet recruiting. Open to male participants aged 40 Years to 80 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-08-27.

Sponsored by Karolinska Institutet · Observational

From the registry’s dates

  • Primary completion was expected by Dec 2025, 10 months ago, but the record still lists the study as not yet recruiting.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
500
Ages
40 Years to 80 Years
Sex
Male
01

Study 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.
02

Conditions studied

  • Prostate Cancer

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03

In context

Prostatic Neoplasms

6,370 studies on the registry are indexed under Prostatic Neoplasms; 1,397 are open to participants now.

This study's planned enrollment of 500 is above the median of 200 across 1,179 observational studies indexed under Prostatic Neoplasms.

Browse Prostatic Neoplasms studies →

Lead sponsor

Karolinska Institutet is the lead sponsor of 1,113 studies on the registry; 267 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
40 Years to 80 Years
Sexes eligible
Male
Accepts healthy volunteers
Yes
Sampling method
Probability sample

Study population

Men meeting local standard of care to undergo prostate MRI for suspicion of prostate cancer

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

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.
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
500 participants (estimated)
Patient registry
No

Interventions

  • Diagnostic testStockholm3

    Stockholm3 combines protein markers tPSA, fPSA, KLK2, PSP94 and GDF15, genetic markers and clinical data to estimate risk for clinically significant prostate cancer.

06

What researchers measure

Primary outcomes

  1. Abnormal MRI

    PIRADS ≥3

    Time frame: From enrollment up to 24 weeks

Secondary outcomes

  1. Clinically significant prostate cancer

    Grade group ≥2 prostate cancer

    Time frame: From enrollment up to 24 weeks

07

Study locations

No study locations are listed for this record.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 27, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06573736
Lead sponsor
Karolinska Institutet
Responsible party
Henrik Grönberg (Professor, Karolinska Institutet) — Principal investigator
First posted
Aug 27, 2024
Start date
Oct 1, 2024 (estimated)
Primary completion
Dec 1, 2025 (estimated)
Completion
Dec 31, 2025 (estimated)
Last update
Aug 27, 2024

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Aug 2024. You cannot join it, but the record below documents what was studied.

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Discussion

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