Prostate CancerSTHLM3ASNCT03956108
Active Surveillance for Low-risk Prostate Cancer - Evaluation of the Efficacy of Minimally Invasive Active Surveillance
A study testing MRI+targeted biopsies+Stockholm3-test and PSA + systematic biopsies in people with Prostate Cancer, run by Karolinska Institutet at 1 site in Sweden.
Trial summary
The STHLM3-AS study will evaluate the specificity of a new proposed protocol for active surveillance using the Stockholm3 test in combination with MRI targeted biopsies for prostate cancer detection in men with diagnosed low-risk prostate cancer undergoing active surveillance in comparison to conventional follow up… Read more about this study
- Who is it for?
- Ages 45 years and older, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- MRI+targeted biopsies+Stockholm3-test and PSA + systematic biopsies
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 280 participants
- Where
- 1 siteSweden
- Study dates
- 1 Aug 2018to 1 Mar 2020
- 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 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men in the STHLM3 study, diagnosed with a low risk prostate cancer and on AS
Who cannot join
- History of treatment for prostate cancer; surgery, radiation, chemotherapy or hormonal treatment.
- Severe illnesses such as metastatic cancers, severe cardio-vascular disease or dementia
- Contraindications for magnetic resonance imaging (MRI) e.g. pacemaker, magnetic cerebral clips, cochlear implants or severe claustrophobia.
Trial locations and contacts
1 site in 1 country.
About this study
The STHLM3-AS study will evaluate the specificity of a new proposed protocol for active surveillance using the Stockholm3 test in combination with MRI targeted biopsies for prostate cancer detection in men with diagnosed low-risk prostate cancer undergoing active surveillance in comparison to conventional follow up using PSA and systematic biopsies.
Read the detailed description
The study design is a cross-sectional study, using a paired design, evaluating our proposed protocol (Stockholm3+MRI+targeted biopsies) versus the standard protocol (PSA+systematic biopsies).
Men from the STHLM3 study, diagnosed with low risk prostate cancer and currently on AS will be invited to the study. Eligible individuals have to be alive without any severe comorbidity and without a history of initiating treatment; surgery, radiation, hormone therapy or chemotherapy. To avoid the need for additional biopsies, invitation will be synchronized with timing for planned follow-up within the AS program for each individual.
At baseline blood will be drawn for PSA and Stockholm3 analyses. The patient will be asked to fill out a study specific questionnaire with questions on anxiety and quality of life. Additionally, a bi-parametric MRI evaluated in line with PI-RADS v2 guidelines will be performed. For men with PIRADS ≥ 3 targeted and systematic biopsies will be performed. For men with PIRADS<3 only systematic biopsies will be performed.
Main outcome measurement will be number of detected significant cancers by each method. Further outcome measurements are the number of performed prostate biopsies with each method and level of anxiety and quality of life.
- Conditions
- Prostate Cancer
- Being tested
- MRI+targeted biopsies+Stockholm3-test, PSA + systematic biopsies
- Keywords
- Active Surveillance
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MRI+targeted biopsies+Stockholm3-testDiagnostic test
MRI, evaluation in accordance with PI-RADS v2, and targeted biopsies. Stockholm3-test.
PSA + systematic biopsiesDiagnostic test
Systematic biopsies and PSA test
| Study group | Role | What they receive |
|---|---|---|
| MRI/Fusion biopsies | Experimental | Stockholm3+MRI+targeted biopsies Receives: Diagnostic Test: MRI+targeted biopsies+Stockholm3-test |
| Systematic biopsies | Active comparator | PSA+systematic biopsies Receives: Diagnostic Test: PSA + systematic biopsies |
What is being measured
The primary outcome is the main question the study is designed to answer.
Specificity of minimally invasive active surveillance
Number of biopsies using the Stockholm3 test in combination with MRI/targeted biopsies vs. number of systematic biopsies at equal sensitivity for detecting Gleason Score ≥ 7 disease
Measured: Up to five years
Secondary outcomes (2)
Predictive value of Stockholm3 test velocity
Stockholm3 test velocity
Measured: Up to five years
Clinically significant cut off for Stockholm3 test as a monitoring test
Stockholm3 test cutoff (0-100% risk)
Measured: Up to five years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2019
- Study start1 Aug 2018
- Primary completion12 Dec 2019
- Study completion1 Mar 2020
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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 280 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karolinska Institutet
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Anna Lantz, Karolinska Institutet
- Investigators
- Anna Lantz, MD PhD, Principal investigator, Karolinska Institutet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03956108
- Sponsor's protocol ID
- 2018/276-31/2
- Acronym
- STHLM3AS
- Status last verified
- Sep 2020
- First submitted
- 15 May 2019
- Last updated
- 10 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Information obtained in the study will be collected in one database. The purpose of the database is to collect study data in a proper and safe way for a long time. All information about the participants will be treated with utmost confidentiality and with strong safeguards to preserve their anonymity. Information that can be used to identify the participant (such as name, address and social security numbers) is always kept separate from other data (such as survey responses and blood tests). All questionnaire data and test results will be treated to prevent unauthorized access to them. The samples will get a unique code so that outsiders cannot identify them. The participants' samples are treated in accordance with the Swedish Biobank Act. Everyone who works with STHLM3 are under confidentiality agreements. Results from the study are presented only as statistics in which individual answers cannot be traced.
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Active Surveillance for Low-risk Prostate Cancer - Evaluation of the Efficacy of Minimally Invasive Active Surveillance
- ClinicalTrials.gov ID
- NCT03956108
- Acronym / sponsor ID
- STHLM3AS / 2018/276-31/2
- Conditions
- Prostate Cancer
- Keywords
- Active Surveillance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 280 participants (actual)
- Lead sponsor
- Karolinska InstitutetUniversity, hospital or other
- Study start
- 1 Aug 2018 (actual)
- Primary completion
- 12 Dec 2019 (actual)
- Study completion
- 1 Mar 2020 (actual)
- First posted
- 20 May 2019 (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.
The STHLM3-AS study will evaluate the specificity of a new proposed protocol for active surveillance using the Stockholm3 test in combination with MRI targeted biopsies for prostate cancer detection in men with diagnosed low-risk prostate cancer undergoing active surveillance in comparison to conventional follow up using PSA and systematic biopsies.
Detailed description
The study design is a cross-sectional study, using a paired design, evaluating our proposed protocol (Stockholm3+MRI+targeted biopsies) versus the standard protocol (PSA+systematic biopsies).
Men from the STHLM3 study, diagnosed with low risk prostate cancer and currently on AS will be invited to the study. Eligible individuals have to be alive without any severe comorbidity and without a history of initiating treatment; surgery, radiation, hormone therapy or chemotherapy. To avoid the need for additional biopsies, invitation will be synchronized with timing for planned follow-up within the AS program for each individual.
At baseline blood will be drawn for PSA and Stockholm3 analyses. The patient will be asked to fill out a study specific questionnaire with questions on anxiety and quality of life. Additionally, a bi-parametric MRI evaluated in line with PI-RADS v2 guidelines will be performed. For men with PIRADS ≥ 3 targeted and systematic biopsies will be performed. For men with PIRADS<3 only systematic biopsies will be performed.
Main outcome measurement will be number of detected significant cancers by each method. Further outcome measurements are the number of performed prostate biopsies with each method and level of anxiety and quality of life.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MRI/Fusion biopsies | Experimental | Diagnostic Test: MRI+targeted biopsies+Stockholm3-testStockholm3+MRI+targeted biopsies |
| Systematic biopsies | Active comparator | Diagnostic Test: PSA + systematic biopsiesPSA+systematic biopsies |
Who may qualify
- Ages
- 45 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Men in the STHLM3 study, diagnosed with a low risk prostate cancer and on AS
Key exclusion criteria (3 listed)
- History of treatment for prostate cancer; surgery, radiation, chemotherapy or hormonal treatment.
- Severe illnesses such as metastatic cancers, severe cardio-vascular disease or dementia
- Contraindications for magnetic resonance imaging (MRI) e.g. 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 |
|---|---|---|
| MRI+targeted biopsies+Stockholm3-testMRI, evaluation in accordance with PI-RADS v2, and targeted biopsies. Stockholm3-test. | Diagnostic test | MRI/Fusion biopsies |
| PSA + systematic biopsiesSystematic biopsies and PSA test | Diagnostic test | Systematic biopsies |
Primary outcome
Specificity of minimally invasive active surveillance
Time frame: Up to five years
Number of biopsies using the Stockholm3 test in combination with MRI/targeted biopsies vs. number of systematic biopsies at equal sensitivity for detecting Gleason Score ≥ 7 disease
2 secondary outcomes
Predictive value of Stockholm3 test velocity
Time frame: Up to five years
Clinically significant cut off for Stockholm3 test as a monitoring test
Time frame: Up to five years
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 10 Sep 2020.
- Individual participant dataSharing planned: No. Information obtained in the study will be collected in one database. The purpose of the database is to collect study data in a proper and safe way for a long time. All information about the participants will be treated with utmost confidentiality and with strong safeguards to preserve their anonymity. Information that can be used to identify the participant (such as name, address and social security numbers) is always kept separate from other data (such as survey responses and blood tests). All questionnaire data and test results will be treated to prevent unauthorized access to them. The samples will get a unique code so that outsiders cannot identify them. The participants' samples are treated in accordance with the Swedish Biobank Act. Everyone who works with STHLM3 are under confidentiality agreements. Results from the study are presented only as statistics in which individual answers cannot be traced.
Related trials for Prostate Cancer
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
Active, not recruitingObservational study
MRI Fusion Biopsy vs. Micro-Ultrasound Guided Biopsy
Prostate Cancer
Enrolling by invitationObservational study
Natural History Study of Early Life Exposures in Agriculture (ELEA)
Prostate Cancer, Leukemia
Not yet recruitingPhase 1/2
STAR0602 With Nivolumab in Non Small Cell Lung Cancer and in Metastatic Castrate-Resistant Prostate Cancer, and STAR0602 Alone in Thymic Carcinoma
NSCLC, Non-Small Cell Lung Cancer
Recruiting
Rehabilitation and Sex Therapy to Optimize Recovery After Prostate Cancer Treatment
Prostate Cancer, Urinary Incontinence
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.
Anna Lantz, MD PhD principal investigator
Karolinska Institutet
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MRI+targeted biopsies+Stockholm3-test and PSA + systematic biopsies 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 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 10 Sep 2020. 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?
Specificity of minimally invasive active surveillance (time frame: Up to five years). 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 10 Sep 2020.