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

Launched by KAROLINSKA INSTITUTET · Aug 23, 2024

Keywords

ClinConnect Summary

This clinical trial is looking at a new blood test called Stockholm3 to see how well it can help doctors decide whether to perform an MRI for prostate cancer. Men who are already scheduled for an MRI due to concerns about prostate cancer will be included in the study. On the day of the MRI, a blood sample will be taken to measure the Stockholm3 biomarker, but it's important to note that the results won't be shared with the participants, and no treatment decisions will be based on these results. The goal is to see if Stockholm3 can better identify men who should get an MRI compared to another common test called PSA.

To participate in this trial, men must be between 40 and 80 years old and already scheduled for an MRI. There are some exclusions, such as men with a very low PSA level, those who already have a prostate cancer diagnosis, or those who have had certain medical procedures in the last three months. Participants can expect to provide a blood sample and undergo their scheduled MRI, helping researchers learn more about the effectiveness of the Stockholm3 test in detecting prostate cancer.

Gender

MALE

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.