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

Population-based screening study: feasibility and effects evaluation of prostate cancer (PCa) screening in Russia and evaluation of economic efficacy

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN12760113

Enrollment

3715

Registered

2014-09-22

Start date

2013-12-01

Completion date

Unknown

Last updated

2020-06-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prostate disease/prostate cancer Cancer

Interventions

1. All involved patients fill questionnaires (IPSS/QoL, SWOP - calculator 1,2 and 4) 2. Blood serum PSA level detection 3. Digital rectal examination (DRE)

Eligibility

Sex/Gender

Male

Inclusion criteria

Inclusion criteria: Men aged 45-65

Exclusion criteria

Exclusion criteria: Prostate cancer in anamnesis

Design outcomes

Primary

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

Secondary

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

Measure

Time frame

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

—

Countries

Russian Federation

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026