Prostate Cancer
Conditions
Brief summary
STHLM3 is a paired diagnostic trial aiming to assess whether a panel of biomarkers for prostate cancer can substantially reduce the proportion of men referred to biopsy whilst maintaining sensitivity for aggressive prostate cancer
Interventions
DIAGNOSTIC_TESTSTHLM3
Sponsors
Region Stockholm
Karolinska Institutet
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
MALE
Age
50 Years to 69 Years
Healthy volunteers
Yes
Inclusion criteria
* Age 50-69 * Residential address in Stockholm County
Exclusion criteria
* Previous Prostate Cancer Diagnosis * Not able to comprehend inform consent material
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of biopsies | Recorded directly after biopsy |
Secondary
| Measure | Time frame |
|---|---|
| Number of Gleason Score ≥ 7 | Recorded directly after biopsy |
| Number of Gleason Score 6 | Recorded directly after biopsy |
| Number of benign | Recorded directly after biopsy |
Countries
Sweden
Outcome results
None listed