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

ISRCTN ISRCTN12760113
DOI https://doi.org/10.1186/ISRCTN12760113
Secondary identifying numbers N/A
Submission date
26/08/2014
Registration date
22/09/2014
Last edited
29/05/2020
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Cancer
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year

Plain English summary of protocol

Background and study aims
Prostate cancer in men is very common. However, it usually develops slowly with the first signs of the disease being problems with urinating once the prostate is large enough to press against the urethra (the tube that takes urine from the bladder to the penis). If caught early, this form of cancer is very treatable and many countries have screening programmes to detect it. Early stage prostate cancer can be diagnosed using a blood test called the prostate-specific antigen (PSA) test. An increased amount of PSA can, in some cases, happen due to prostate cancer. In Russia, the number of men with prostate cancer is rather high, is increasing and has a high mortality rate (high number of men dying from the disease). The high mortality rate is a result of a large number of cases not being diagnosed until the disease is at an advanced stage and has already spread to other parts of the body. A PSA test cannot be used to definitely detect the condition as it can also be raised due to, for example, non-cancerous growths and urinary tract diseases. However, Russia healthcare services do need a method to detect prostate cancer earlier. Here, we are going to look at how possible it is to have a PSA test screening programme in Russia, how well it would perform and whether it would be worth spending money on such a programme. We want to estimate how many men in a particular region have the disease, at what stage the cancer is detected and how useful a PSA test might be in screening for the disease, particularly for men aged 45-54 (as this age group is less likely to be included in PSA screening programmes). We also want to calculate how much a screening programme would cost and whether it would be worth the money involved, taking into account the relatively short male life expectancy in Russia.

Who can participate?
Men aged 45-65 in the Novohopersk area of the Voronezh Region (VO)

What does the study involve?
After gathering clinical information for all the participants (from the state medical compulsory insurance system), they are invited for a PSA test at a study centre. They then have a physical examination to check for prostate cancer and undergo a transrectal ultrasound scan (TRUS) to see how large the prostate gland is. In those cases where prostate cancer is found, the affected participants undergo further tests to see how far the cancer has progressed (pelvic MRI, bone scintigraphy and possible abdominal, peritoneal and thoracic CT scans).

What are the possible benefits and risks of participating?
The major benefits to participants taking part in the study are a high quality medical examination and early detection of prostate cancer. The risks involve infections and other complications and side-effects of biopsy.

Where is the study run from?
1. Federal State Research Scientific Institute of Urology of the Health Ministry of Russia (Russia)
2. Healthcare Department of Voronezh Region (Russia)
3. MBHI “Novohapersk Central Regional Hospital” (Russia)
4. VO BHI “Voronezh Regional Clinical Hospital N1” (Russia)

When is the study starting and how long is it expected to run for?
December 2013 to January 2015.

Who is funding the study?
1. Federal State Research Scientific Institute of Urology of the Health Ministry of Russia (Russia)
2. Healthcare Department of Voronezh Region (Russia)
3. MBHI “Novohapersk Central Regional Hospital” (Russia)
4. VO BHI “Voronezh Regional Clinical Hospital N1” (Russia)
5. LLC “Beckman Coulter” (Russia)

Who is the main contact?
Professor Oleg Apolikhin
Apolikhin.oleg@gmail.com

Contact information

Prof Oleg Apolikhin
Scientific

3d Parkovaya str
Moscow
105425
Russian Federation

Phone +7 (0) 499 367 75 87
Email apolikhin.oleg@gmail.com

Study information

Study design12-months population-based study
Primary study designInterventional
Secondary study designSingle-centre
Study setting(s)Other
Study typeScreening
Participant information sheet Not available in web format, please use the following contact details to request a patient information sheet: Federal State Budget Scientific Research Institute of Urology, Ministry of Health Care of Russian Federation, Moscow 105425 3d Parkovaya 51, phone +7 499 367 75 87, email: apolikhin.oleg@gmail.com or international.uro@gmail.com
Scientific titlePopulation-based screening study: feasibility and effects evaluation of prostate cancer (PCa) screening in Russia and evaluation of economic efficacy
Study acronymSPiNAV
Study objectivesIt is hypothesized that screening decreases mortality.
Ethics approval(s)Local ethical committee, 28/10/2013, ref. N98
Health condition(s) or problem(s) studiedProstate disease/prostate cancer
Intervention1. All involved patients fill questionnaires (IPSS/QoL, SWOP - calculator 1,2 and 4)
2. Blood serum PSA level detection
3. Digital rectal examination (DRE)
4. Transrectal ultrasound scan (TRUS)
5. Pelvic MRI (1 month after prostate biopsy)
6. Bone scintigraphy (PSA level ≥ 20 ng/ml)
7. Thorax CT, X ray
8. Abdominal, peritoneal and thoracic CT scan (by indications)
Intervention typeOther
Primary outcome measure1. 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 outcome measures1. 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
Overall study start date01/12/2013
Completion date01/01/2015

Eligibility

Participant type(s)Patient
Age groupAdult
SexMale
Target number of participants3715
Key inclusion criteriaMen aged 45-65
Key exclusion criteriaProstate cancer in anamnesis
Date of first enrolment01/12/2013
Date of final enrolment01/01/2015

Locations

Countries of recruitment

  • Russian Federation

Study participating centre

3d Parkovaya str
Moscow
105425
Russian Federation

Sponsor information

Federal State Research Institute of Urology of Ministry of Health Care of Russia (Russia)
Government

3d Parkovaya str., 51
Moscow
105425
Russian Federation

Phone +7 (0) 499 165 84 37
Email international.uro@gmail.com
Website http://uro.ru
ROR logo "ROR" https://ror.org/01p8ehb87

Funders

Funder type

Other

Federal State Research Institute of Urology of the Ministry of Health Care of Russia, Moscow (Russia)

No information available

Healthcare Department of Voronezh Region (Russia)

No information available

MBHI “Novohapersk Central Regional Hospital” (Russia)

No information available

VO BHI “Voronezh Regional clinical hospital N1” (Russia)

No information available

LLC “Beckman Coulter” (Russia)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Editorial Notes

29/05/2020: No publications found.