Prostate Cancer Clinical Trial
— STHLM3Official title:
STHLM3 - Prostate Cancer Diagnostic Trial
| NCT number | NCT03639649 |
| Other study ID # | Karolinska1 |
| Secondary ID | |
| Status | Completed |
| Phase | N/A |
| First received | |
| Last updated | |
| Start date | August 2013 |
| Est. completion date | February 2015 |
| Verified date | August 2018 |
| Source | Karolinska Institutet |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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
| Status | Completed |
| Enrollment | 58818 |
| Est. completion date | February 2015 |
| Est. primary completion date | February 2015 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | Male |
| Age group | 50 Years to 69 Years |
| Eligibility |
Inclusion Criteria: - Age 50-69 - Residential address in Stockholm County Exclusion Criteria: - Previous Prostate Cancer Diagnosis - Not able to comprehend inform consent material |
| Country | Name | City | State |
|---|---|---|---|
| Sweden | Karolinska Institutet | Stockholm |
| Lead Sponsor | Collaborator |
|---|---|
| Karolinska Institutet | Stockholm County Council, Sweden |
Sweden,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Number of biopsies | Recorded directly after biopsy | ||
| Secondary | Number of Gleason Score = 7 | Recorded directly after biopsy | ||
| Secondary | Number of Gleason Score 6 | Recorded directly after biopsy | ||
| Secondary | Number of benign | Recorded directly after biopsy |
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