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

NCT ID: NCT06573736

Last Updated: 2024-08-27

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Total Enrollment: 500 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-10-01
• Study Completion Date: 2025-12-31

Brief 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.

Conditions

Prostate Cancer

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Interventions

Stockholm3

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

Intervention Type: DIAGNOSTIC_TEST

Eligibility 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.

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Karolinska Institutet

OTHER

Sponsor Role: lead

Responsible Party

Henrik Grönberg

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

2023-06092-01

Identifier Type: -

Identifier Source: org_study_id