Condition category
Cancer
Date applied
26/08/2014
Date assigned
22/09/2014
Last edited
22/10/2014
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

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

Trial website

Contact information

Type

Scientific

Primary contact

Prof Oleg Apolikhin

ORCID ID

Contact details

3d Parkovaya str
Moscow
105425
Russian Federation
+7 (0) 499 367 75 87
apolikhin.oleg@gmail.com

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

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

Acronym

SPiNAV

Study hypothesis

It is hypothesized that screening decreases mortality.

Ethics approval

Local ethical committee, 28/10/2013, ref. N98

Study design

12-months population-based study

Primary study design

Interventional

Secondary study design

Single-centre

Trial setting

Other

Trial type

Screening

Patient 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

Condition

Prostate disease/prostate cancer

Intervention

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)
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 type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

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 outcome measures

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

Overall trial start date

01/12/2013

Overall trial end date

01/01/2015

Reason abandoned

Eligibility

Participant inclusion criteria

Men aged 45-65

Participant type

Patient

Age group

Adult

Gender

Male

Target number of participants

3715

Participant exclusion criteria

Prostate cancer in anamnesis

Recruitment start date

01/12/2013

Recruitment end date

01/01/2015

Locations

Countries of recruitment

Russian Federation

Trial participating centre

3d Parkovaya str
Moscow
105425
Russian Federation

Sponsor information

Organisation

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

Sponsor details

3d Parkovaya str.
51
Moscow
105425
Russian Federation
+7 (0) 499 165 84 37
international.uro@gmail.com

Sponsor type

Government

Website

http://uro.ru

Funders

Funder type

Other

Funder name

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

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Healthcare Department of Voronezh Region (Russia)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

MBHI “Novohapersk Central Regional Hospital” (Russia)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

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

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

LLC “Beckman Coulter” (Russia)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes