Status:
NOT_YET_RECRUITING
Stockholm3 Use Prior to MRI for Prostate Cancer Detection in a Clinical Care Pathway: a Multi-centered Validation
Lead Sponsor:
Karolinska Institutet
Conditions:
Prostate Cancer
Eligibility:
MALE
40-80 years
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 me...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
October 1 2024
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 31 2025
Estimated Enrollment :
500 Patients enrolled
Trial Details
Trial ID
NCT06573736
Start Date
October 1 2024
End Date
December 31 2025
Last Update
August 27 2024
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