Condition category
Cancer
Date applied
14/11/2012
Date assigned
03/01/2013
Last edited
19/07/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Prostate cancer is a leading cause of cancer death among men in the Western world. A PSA test looks for raised levels of PSA in the blood that may be a sign of prostate cancer in its early stages. Although PSA screening has been shown to prevent deaths, it can also lead to over-diagnosis (diagnosis of disease that would not have caused symptoms or death) and performing unnecessary biopsies (where a sample of the prostate is taken for diagnosis). The aim of this study is to assess whether a new biomarker test for prostate cancer can reduce how many men are referred to biopsy whilst still detecting high-risk prostate cancer. The study will also assess whether the new test decreases the number of low-risk prostate cancers diagnosed and improves the quality and effectiveness of prostate cancer diagnosis in routine health care in Stockholm.

Who can participate?
Men aged 50 to 69 living in Stockholm County Council or Region Gotland who have not previously been diagnosed with prostate cancer

What does the study involve?
Participants are randomly allocated to one of two groups. One group are referred to biopsy based on the PSA test result only. The other group are referred to biopsy based on their age, their genes, their family history and biomarkers.

What are the possible benefits and risks of participating?
There are no benefits for the participants other than a free prostate cancer test. There is a low risk of over-diagnosis of low-risk cancers.

Where is the study run from?
Karolinska Institutet (Sweden)

When is the study starting and how long is it expected to run for?
January 2013 to December 2014

Who is funding the study?
Stockholm County Council (Sweden)

Who is the main contact?
Prof. Henrik Grönberg

Trial website

http://sthlm3.se

Contact information

Type

Scientific

Primary contact

Prof Henrik Grönberg

ORCID ID

Contact details

Nobels väg 12
Stockholm
17177
Sweden

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

STHLM3 - Prostate cancer diagnostic randomized trial

Acronym

STHLM3

Study hypothesis

STHLM3 [STHLM relates to the city of Stockholm, Number 3 relates to that this is the third study within the same setting] is a randomized controlled trial aiming to assess whether a panel of biomarkers for prostate cancer can substantially reduce the proportion of men referred to biopsy whilst maintaining sensitivity for high risk prostate cancer.

Ethics approval

Stockholm Ethical Review Board, 09/05/2012, ref: r DNR 2012/572-31/1

Study design

Two-armed randomized controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Diagnostic

Patient information sheet

Patient information in Swedish can be found at http://sthlm3.se/dokument/

Condition

Prostate cancer

Intervention

The two study arms will be:

Control/PSA arm, where referral to biopsy will be based on Prostate-specific antigen (PSA) only with PSA ≥ 3 as the level of referral to prostate biopsy

Intervention/Best biomarker panel (BBP) arm, where referral to biopsy will be determined by a risk prediction model based on age, an array of single-nucleotide polymorphism (SNPs), family history and protein-based biomarkers.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

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

1. To decrease the number of low risk prostate cancers diagnosed
2. To increase the health related quality of life and knowledge of prostate cancer testing
3. To assess the health economic consequences of implementing prostate cancer screening
4. To improve the quality and effectiveness of prostate cancer diagnosis in the routine health care in Stockholm
5. To assess the overall long-term mortality of prostate cancer in the Stockholm/Gotland area over a 10-15 year period
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
7. To facilitate inclusion in active surveillance protocol in men diagnosed with low risk prostate cancers

Overall trial start date

01/01/2013

Overall trial end date

31/12/2014

Reason abandoned

Eligibility

Participant 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.

Participant type

All

Age group

Adult

Gender

Male

Target number of participants

140,000

Participant exclusion criteria

Diagnosed with prostate cancer

Recruitment start date

01/01/2013

Recruitment end date

31/12/2014

Locations

Countries of recruitment

Sweden

Trial participating centre

Nobels väg 12
Stockholm
17177
Sweden

Sponsor information

Organisation

Karolinska Institutet (Sweden)

Sponsor details

Department of Medical Epidemiology and Biostatistics
PO Box 281
Stockholm
17177
Sweden

Sponsor type

Research organisation

Website

http://ki.se/ki/jsp/polopoly.jsp?l=en&d=9600

Funders

Funder type

Government

Funder name

Stockholm County Council (Sweden)

Alternative name(s)

Stockholm County Council

Funding Body Type

government organisation

Funding Body Subtype

government non-federal

Location

Sweden

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

2015 results in: http://www.ncbi.nlm.nih.gov/pubmed/26563502

Publication citations

Additional files

Editorial Notes

19/07/2016: Plain English summary added. 04/05/2016: Publication reference added.