Prostate disease Screening Program in Novohopersk area of Voronezh region (Novohopersk)

Not Applicable

Completed

• Conditions: Prostate disease/prostate cancer; Cancer

• Registration Number: ISRCTN12760113
• Lead Sponsor: Federal State Research Institute of Urology of Ministry of Health Care of Russia (Russia)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2014-09-22
• Study Completion: 2015-01-01
• Last Update Posted: 8 June 2020

Recruitment & Eligibility

• Status: Completed
• Sex: Male
• Target Recruitment: 3715

Inclusion Criteria

Men aged 45-65

Exclusion Criteria

Prostate cancer in anamnesis

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<br> 1. Prostate cancer detection rate (%)<br> 2. Prostate cancer detection rate in age groups (%)<br> 3. Prostate cancer detection rate by stages (TNM system)<br> 4. PSA sensitivity, specificity, PPV and NPV (%)<br> 5. Prostate cancer detection costs in one patient in rubles<br> 6. Localized clinically significant (treatment needed) prostate cancer detection costs in one patient in rubles<br>

Secondary Outcome Measures

Name	Time	Method
<br> 1. Questionnaires (IPSS/QoL, SWOP ? calculator 1,2 and 4) - results registered in points and percents<br> 2. Blood serum PSA level detection (PSA) - ng/ml<br> 3. Digital rectal examination (DRE) - positive/negative<br> 4. Transrectal ultrasound scan (TRUS), (positive/negative) including determination of prostate volume in cc<br> 5. Prostate biopsy (standard 12 core) with morphological examination of tissue samples<br> 6. Cancer staging - registered in TNM system<br>