Prostate CancerNCT02788825
STHLM3-MR: Comparing Standard With Targeted Prostate Biopsies
A study testing Targeted biopsies using Magnetic Resonance Imaging guiding in people with Prostate Cancer, run by Karolinska Institutet at 2 sites in 2 countries.
Trial summary
Prostate cancer is a leading cause of cancer death among men in the Western world. Early detection of prostate cancer has been shown to decrease mortality, but has limitations with low specificity leading to unnecessary biopsies and over-diagnosis of low-risk cancers. Read more about this study
- Who is it for?
- Ages 45 to 75 years, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- Targeted biopsies using Magnetic Resonance Imaging guiding
- Type of treatment
- Surgery or procedure
- How many people
- 687 participants
- Where
- 2 sitesin 2 countries
- Study dates
- Apr 2016to Aug 2017
- 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 45 to 75 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men age 45-75 years referred to any of the participating urological centers for prostate biopsies
Who cannot join
- A prior diagnosis of prostate cancer (ICD-9 C61)
- Severe illnesses such as metastatic cancers, severe cardio-vascular disease or dementia
- Contraindications for magnetic resonance imaging (MRI) eg pacemaker, magnetic cerebral clips, cochlear implants or severe claustrophobia.
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
About this study
Prostate cancer is a leading cause of cancer death among men in the Western world. Early detection of prostate cancer has been shown to decrease mortality, but has limitations with low specificity leading to unnecessary biopsies and over-diagnosis of low-risk cancers. The STHLM3 trial has paved the way for improved specificity in early detection of prostate cancer using the blood-based STHLM3 test for identifying men at increased risk of harbouring significant prostate cancer.
Targeted prostate biopsies based on MRI images have been shown to increase sensitivity of high-grade cancers compared to the currently used systematic biopsies, but existing evidence are contradictory and not free from methodological flaws.
Read more
The primary aim of STHLM3-MR/Fusion is to increase the specificity in early detection of prostate cancer without decreasing the sensitivity of aggressive prostate cancers by introducing targeted prostate biopsies and comparing to traditional prostate biopsies. The primary endpoints are the number of performed biopsies and the number of detected high-grade prostate cancers defined as Gleason 7 or higher. Secondary endpoints include the number of low risk prostate cancers diagnosed and the proportion of patients with up-or downgraded disease after assessment of prostatectomy specimen. Additional aims include to assess the health economic consequences of implementing MRI based prostate cancer diagnostics and to improve the quality and effectiveness of prostate cancer diagnosis in the routine health care in Stockholm.
The STHLM3-MR/Fusion project will be performed in two separate phases, analyzed separately. Based on power calculations, approximately 500 planned for prostate biopsies will be included in the first phase. Men who have previously been diagnosed with prostate cancer may not take part in the study. The study period of Phase 1 is March 2016 to January 2017. The second phase will start in autumn 2016 and end by December 2017.
- Conditions
- Prostate Cancer
- Being tested
- Targeted biopsies using Magnetic Resonance Imaging guiding
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Targeted biopsies using Magnetic Resonance Imaging guidingProcedure or surgery
Prostate biopsies targeted by findings on MRI where findings are classified according to PI-RADS v2.
What is being measured
The primary outcome is the main question the study is designed to answer.
Estimated number of targeted biopsies needed to maintain Gleason sum 7 sensitivity as compared with systematic biopsies.
Measured: Assessed after 500 (paired) biopsies are performed in Stockholm. Timeframe: from April 2016 to April 2017, up to 1 year
Total number Gleason sum ≥7 tumours detected by targeted and systematic biopsies, respectively
Measured: Assessed after 500 (paired) biopsies are performed in Stockholm. Timeframe: from April 2016 to April 2017, up to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2016 (estimated)
- Study startApr 2016
- Primary completionAug 2017
- Study completionAug 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 687 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karolinska Institutet
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tobias Nordström, Karolinska Institutet
- Investigators
- Tobias Nordström, MD PhD, Principal investigator, Dpt Medical Epidemiology and Biostatistics, Karolinska Institutet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02788825
- Sponsor's protocol ID
- STHLM3MR-1
- Status last verified
- Aug 2017
- First submitted
- 11 May 2016
- Last updated
- 22 Aug 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
Lantz A, Haug ES, Picker W, Crippa A, Jaderling F, Mortezavi A, Nordstrom T. Effect of information on prostate biopsy history on biopsy outcomes in the era of MRI-targeted biopsies. World J Urol. 2021 Apr;39(4):1153-1159. doi: 10.1007/s00345-020-03277-x. Epub 2020 May 29.
PubMed 32472278
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- STHLM3-MR: Comparing Standard With Targeted Prostate Biopsies
- ClinicalTrials.gov ID
- NCT02788825
- Acronym / sponsor ID
- STHLM3MR-1
- Conditions
- Prostate Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 687 participants (actual)
- Lead sponsor
- Karolinska InstitutetUniversity, hospital or other
- Study start
- Apr 2016
- Primary completion
- Aug 2017 (actual)
- Study completion
- Aug 2017 (actual)
- First posted
- 2 Jun 2016 (estimated)
- 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.
Prostate cancer is a leading cause of cancer death among men in the Western world. Early detection of prostate cancer has been shown to decrease mortality, but has limitations with low specificity leading to unnecessary biopsies and over-diagnosis of low-risk cancers. The STHLM3 trial has paved the way for improved specificity in early detection of prostate cancer using the blood-based STHLM3 test for identifying men at increased risk of harbouring significant prostate cancer.
Targeted prostate biopsies based on MRI images have been shown to increase sensitivity of high-grade cancers compared to the currently used systematic biopsies, but existing evidence are contradictory and not free from methodological flaws.
The primary aim of STHLM3-MR/Fusion is to increase the specificity in early detection of prostate cancer without decreasing the sensitivity of aggressive prostate cancers by introducing targeted prostate biopsies and comparing to traditional prostate biopsies. The primary endpoints are the number of performed biopsies and the number of detected high-grade prostate cancers defined as Gleason 7 or higher. Secondary endpoints include the number of low risk prostate cancers diagnosed and the proportion of patients with up-or downgraded disease after assessment of prostatectomy specimen. Additional aims include to assess the health economic consequences of implementing MRI based prostate cancer diagnostics and to improve the quality and effectiveness of prostate cancer diagnosis in the routine health care in Stockholm.
The STHLM3-MR/Fusion project will be performed in two separate phases, analyzed separately. Based on power calculations, approximately 500 planned for prostate biopsies will be included in the first phase. Men who have previously been diagnosed with prostate cancer may not take part in the study. The study period of Phase 1 is March 2016 to January 2017. The second phase will start in autumn 2016 and end by December 2017.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 45 to 75 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Men age 45-75 years referred to any of the participating urological centers for prostate biopsies
Key exclusion criteria (3 listed)
- A prior diagnosis of prostate cancer (ICD-9 C61)
- Severe illnesses such as metastatic cancers, severe cardio-vascular disease or dementia
- Contraindications for magnetic resonance imaging (MRI) eg pacemaker, magnetic cerebral clips, cochlear implants or severe claustrophobia.
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 |
|---|---|---|
| Targeted biopsies using Magnetic Resonance Imaging guidingProstate biopsies targeted by findings on MRI where findings are classified according to PI-RADS v2. | Procedure or surgery | – |
Primary outcome
Estimated number of targeted biopsies needed to maintain Gleason sum 7 sensitivity as compared with systematic biopsies.
Time frame: Assessed after 500 (paired) biopsies are performed in Stockholm. Timeframe: from April 2016 to April 2017, up to 1 year
Total number Gleason sum ≥7 tumours detected by targeted and systematic biopsies, respectively
Time frame: Assessed after 500 (paired) biopsies are performed in Stockholm. Timeframe: from April 2016 to April 2017, up to 1 year
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 22 Aug 2017.
- Derived from this study: PubMed 32472278Lantz A, Haug ES, Picker W, Crippa A, Jaderling F, Mortezavi A, Nordstrom T. Effect of information on prostate biopsy history on biopsy outcomes in the era of MRI-targeted biopsies. World J Urol. 2021 Apr;39(4):1153-1159. doi: 10.1007/s00345-020-03277-x. Epub 2020 May 29.
- Website STHLM3 projectsLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
Related trials for Prostate Cancer
RecruitingPhase 1/2
Docetaxel and SX-682 in Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma, Salivary Gland Carcinoma, and Advanced Prostate Cancer
Head and Neck Cancer, Head and Neck Squamous Cell Carcinoma
Enrolling by invitationObservational study
Natural History Study of Early Life Exposures in Agriculture (ELEA)
Prostate Cancer, Leukemia
RecruitingPhase 2
Testing the Effectiveness of Two Immunotherapy Drugs (Nivolumab and Ipilimumab) With One Anti-cancer Targeted Drug (Cabozantinib) for Rare Genitourinary Tumors
Bladder Adenocarcinoma, Bladder Clear Cell Adenocarcinoma
RecruitingObservational study
cfDNA Assay Prospective Observational Validation for Early Cancer Detection and Minimal Residual Disease
Brain Cancer, Breast Cancer
RecruitingPhase 3
Diagnostic Performance of [18F]PSMA-1007 PET/CT Imaging in Patients With Newly-Diagnosed Prostate Cancer
Prostate Cancer
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.
Tobias Nordström, MD PhD principal investigator
Dpt Medical Epidemiology and Biostatistics, Karolinska Institutet
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Targeted biopsies using Magnetic Resonance Imaging guiding in people with Prostate Cancer, run by Karolinska Institutet at 2 sites in 2 countries.
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 1 inclusion and 3 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 22 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Norway, 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?
Estimated number of targeted biopsies needed to maintain Gleason sum 7 sensitivity as compared with systematic biopsies. (time frame: Assessed after 500 (paired) biopsies are performed in Stockholm. Timeframe: from April 2016 to April 2017, up to 1 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02788825, which also lists 1 linked publication.
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 22 Aug 2017.