Active Surveillance for Low-risk Prostate Cancer - Evaluation of the Efficacy of Minimally Invasive Active Surveillance
NCT ID: NCT03956108
Last Updated: 2020-09-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
280 participants
INTERVENTIONAL
2018-08-01
2020-03-01
Brief Summary
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Detailed Description
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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
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Study Design
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NON_RANDOMIZED
PARALLEL
DIAGNOSTIC
NONE
Study Groups
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MRI/Fusion biopsies
Stockholm3+MRI+targeted biopsies
MRI+targeted biopsies+Stockholm3-test
MRI, evaluation in accordance with PI-RADS v2, and targeted biopsies. Stockholm3-test.
Systematic biopsies
PSA+systematic biopsies
PSA + systematic biopsies
Systematic biopsies and PSA test
Interventions
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MRI+targeted biopsies+Stockholm3-test
MRI, evaluation in accordance with PI-RADS v2, and targeted biopsies. Stockholm3-test.
PSA + systematic biopsies
Systematic biopsies and PSA test
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* 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.
45 Years
MALE
No
Sponsors
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Karolinska Institutet
OTHER
Responsible Party
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Anna Lantz
Principal Investigator
Principal Investigators
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Anna Lantz, MD PhD
Role: PRINCIPAL_INVESTIGATOR
Karolinska Institutet
Locations
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Karolinska Institutet
Stockholm, Solna, Sweden
Countries
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Provided Documents
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Document Type: Informed Consent Form
Other Identifiers
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2018/276-31/2
Identifier Type: -
Identifier Source: org_study_id
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