STHLM3 - Prostate cancer diagnostic trial
Not Applicable
Completed
- Conditions
- Prostate cancerCancerMalignant neoplasm of prostate
- Registration Number
- ISRCTN84445406
- Lead Sponsor
- Karolinska Institutet (Sweden)
- Brief Summary
2015 Results article in http://www.ncbi.nlm.nih.gov/pubmed/26563502 results 2022 Results article in https://pubmed.ncbi.nlm.nih.gov/36185581/ (added 04/10/2022)
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Male
- Target Recruitment
- 140000
Inclusion Criteria
All men between 50 and 69 years of age who have a permanent postal address in Stockholm County Council or Region Gotland (N=260,000) will be asked whether they would like to take part in STHLM3.
Exclusion Criteria
Diagnosed with prostate cancer
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To increase the specificity of a combined prostate cancer test compared to the PSA test without decreasing the sensitivity of high risk of prostate cancers (defined as Gleason 7 or higher). The primary endpoint is number of prostate biopsies.
- Secondary Outcome Measures
Name Time Method <br> 1. To decrease the number of low risk prostate cancers diagnosed<br> 2. To increase the health related quality of life and knowledge of prostate cancer testing<br> 3. To assess the health economic consequences of implementing prostate cancer screening<br> 4. To improve the quality and effectiveness of prostate cancer diagnosis in the routine health care in Stockholm<br> 5. To assess the overall long-term mortality of prostate cancer in the Stockholm/Gotland area over a 10-15 year period<br> 6. To assess the combination of a blood based ?best biomarker panel? and urine biomarkers in men with initial negative prostate biopsy (separate study protocol STHLM3-Rebiopsy) and<br> 7. To facilitate inclusion in active surveillance protocol in men diagnosed with low risk prostate cancers<br>