Stockholm3 Use Prior to MRI for Prostate Cancer Detection in a Clinical Care Pathway: a Multi-centered Validation
- Conditions
- Prostate Cancer
- Registration Number
- NCT06573736
- Lead Sponsor
- Karolinska Institutet
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Not yet recruiting
- Sex
- Male
- Target Recruitment
- 500
Inclusion Criteria:<br><br> - Men with age range (40.0 - 80.0 years)<br><br> - Already scheduled to undergo MRI for prostate cancer screening (both negative and<br> positive MRI included).<br><br>Exclusion Criteria:<br><br> - PSA < 1.5 ng/mL<br><br> - Any known diagnosis of prostate cancer (patient on active surveillance)<br><br> - Men that have undergone digital rectal exam (DRE) immediately before blood draw (DRE<br> within 5 days of study blood draw are excluded).<br><br> - Men who in the three (3) months prior to study participation received any invasive<br> urologic procedure such as thermotherapy, microwave therapy, laser therapy,<br> transurethral resection of the prostate (TURP), urethral catheterization, and lower<br> genitourinary tract endoscopy (cystoscopy)<br><br> - No history of new treatment for BPH in three (3) months prior to study<br> participation.
Not provided
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Abnormal MRI
- Secondary Outcome Measures
Name Time Method Clinically significant prostate cancer