Stockholm3 Use Prior to MRI for Prostate Cancer Detection in a Clinical Care Pathway: a Multi-centered Validation (S3M-MRI)

August 23, 2024 updated by: Henrik Grönberg, Karolinska Institutet

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

500

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

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

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Abnormal MRI
Time Frame: From enrollment up to 24 weeks
PIRADS ≥3
From enrollment up to 24 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinically significant prostate cancer
Time Frame: From enrollment up to 24 weeks
Grade group ≥2 prostate cancer
From enrollment up to 24 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Karolinska Institutet

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

October 1, 2024

Primary Completion (Estimated)

December 1, 2025

Study Completion (Estimated)

December 31, 2025

Study Registration Dates

First Submitted

August 21, 2024

First Submitted That Met QC Criteria

August 23, 2024

First Posted (Actual)

August 27, 2024

Study Record Updates

Last Update Posted (Actual)

August 27, 2024

Last Update Submitted That Met QC Criteria

August 23, 2024

Last Verified

August 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2023-06092-01

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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