Prostate CancerSTHLM3NCT03639649
STHLM3 - Prostate Cancer Diagnostic Trial
A study testing STHLM3 in people with Prostate Cancer, run by Karolinska Institutet at 1 site in Sweden.
Trial summary
STHLM3 is a paired diagnostic 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 aggressive prostate cancer Read more about this study
- Who is it for?
- Ages 50 to 69 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- STHLM3
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 58,818 participants
- Where
- 1 siteSweden
- Study dates
- Aug 2013to Feb 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 69 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age 50-69
- Residential address in Stockholm County
Who cannot join
- Previous Prostate Cancer Diagnosis
- Not able to comprehend inform consent material
Trial locations and contacts
1 site in 1 country.
About this study
STHLM3 is a paired diagnostic 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 aggressive prostate cancer
- Conditions
- Prostate Cancer
- Being tested
- STHLM3
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
STHLM3Diagnostic test
| Study group | Role | What they receive |
|---|---|---|
| STHLM3 | Experimental | Not described Receives: Diagnostic Test: STHLM3 |
| PSA | Active comparator | Not described Receives: Diagnostic Test: STHLM3 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of biopsies
Measured: Recorded directly after biopsy
Secondary outcomes (3)
Number of Gleason Score ≥ 7
Measured: Recorded directly after biopsy
Number of Gleason Score 6
Measured: Recorded directly after biopsy
Number of benign
Measured: Recorded directly after biopsy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2018
- Study startAug 2013
- Primary completionFeb 2015
- Study completionFeb 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- More trials run by Karolinska InstitutetThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 58,818 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karolinska Institutet
- Sponsor type
- University, hospital or other
- Collaborators
- Region Stockholm
- Responsible party
- Principal investigator, Henrik Grönberg, Karolinska Institutet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03639649
- Sponsor's protocol ID
- Karolinska1
- Acronym
- STHLM3
- Status last verified
- Aug 2018
- First submitted
- 16 Aug 2018
- Last updated
- 21 Aug 2018
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- STHLM3 - Prostate Cancer Diagnostic Trial
- ClinicalTrials.gov ID
- NCT03639649
- Acronym / sponsor ID
- STHLM3 / Karolinska1
- Conditions
- Prostate Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 58,818 participants (actual)
- Lead sponsor
- Karolinska InstitutetUniversity, hospital or other
- Collaborators
- Region Stockholm
- Study start
- Aug 2013
- Primary completion
- Feb 2015 (actual)
- Study completion
- Feb 2015 (actual)
- First posted
- 21 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
STHLM3 is a paired diagnostic 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 aggressive prostate cancer
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| STHLM3 | Experimental | Diagnostic Test: STHLM3 |
| PSA | Active comparator | Diagnostic Test: STHLM3 |
Who may qualify
- Ages
- 50 to 69 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age 50-69
- Residential address in Stockholm County
Key exclusion criteria (2 listed)
- Previous Prostate Cancer Diagnosis
- Not able to comprehend inform consent material
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| STHLM3 | Diagnostic test | PSA, STHLM3 |
Primary outcome
Number of biopsies
Time frame: Recorded directly after biopsy
3 secondary outcomes
Number of Gleason Score ≥ 7
Time frame: Recorded directly after biopsy
Number of Gleason Score 6
Time frame: Recorded directly after biopsy
Number of benign
Time frame: Recorded directly after biopsy
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2018.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing STHLM3 in people with Prostate Cancer, run by Karolinska Institutet at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of biopsies (time frame: Recorded directly after biopsy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Aug 2018.