bpMRI and Risk Based Shared Clinical Decision Making in Prostate Cancer Diagnosis
NCT ID: NCT04287088
Last Updated: 2021-11-23
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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RECRUITING
NA
600 participants
INTERVENTIONAL
2020-02-17
2041-12-31
Brief Summary
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The trial will enrol 600 patients. The primary outcome measure is the the proportion of men with CSPCa (Gleason 4+3 prostate cancer or higher) between the control and intervention arms at baseline. Eligible men are randomised 1:1 in two groups. In control arm in all men prostate biopsies are performed after MRI whereas in intervention arm prostate biopsies are performed only after a shared decision-making between urologist and the patient and the discussion is based on risk estimation.
Detailed Description
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The trial will enrol 600 patients from four hospital districts: Varsinais-Suomi, Satakunta, Pirkanmaa and Keski-Suomi. Key inclusion criteria are suspicion of prostate cancer based on elevated PSA and/or abnormal digital rectal examination. Men with previous PCa diagnosis and contraindications for MRI are excluded. The primary outcome measure is the comparison of the proportion of men with CSPCa (Gleason 4+3 prostate cancer or higher) between the control and intervention arms at baseline.
Using PSA as strata, eligible men are randomised 1:1 in two groups. After randomisation MRI examination is performed and interpreted by one experienced uro-radiologist using Likert and PI-RADS2.1 classifications. In control arm in all men prostate biopsies are performed after MRI whereas in intervention arm prostate biopsies are performed only after a shared decision-making between urologist and the patient and the discussion is based on risk estimation. Men with negative biopsies or with no biopsies performed are all assigned for five-year follow-up with semi-annual PSA. Long-term follow-up based on health records and national registries is performed for additional 15 years for all patients.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
DIAGNOSTIC
NONE
Study Groups
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Control
After IMPROD bpMRI all men undergo prostate biopsies. In men with Likert scores of 1-2, TRUS guided systematic biopsies are performed. In men with Likert 3-5 score, in addition to systematic biopsies, two targeted biopsies are taken from each lesion (up to two lesions).
No interventions assigned to this group
Intervention
After IMPROD bpMRI prostate biopsies are performed according to shared decision-making by the treating urologist and the patient. If biopsies are to be performed, in men with IMPROD bpMRI likert scores of 1-2, 12-core systematic TRUS guided biopsies are performed and in men with Likert 3-5 score lesions systematic biopsies are performed and two targeted biopsies are taken from each lesion (up to two lesions). If biopsies are not performed, men are referred for a PSA follow-up.
A shared decision making
Based on prostate cancer risk calculation (age, usage of 5-ARI medication, baseline PSA, IMPROD bpMRI Likert, prostate volume) a shared decision making whether to perform prostate biopsies or not
Interventions
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A shared decision making
Based on prostate cancer risk calculation (age, usage of 5-ARI medication, baseline PSA, IMPROD bpMRI Likert, prostate volume) a shared decision making whether to perform prostate biopsies or not
Eligibility Criteria
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Inclusion Criteria
* Language spoken: Finnish
* Clinical suspicion of prostate cancer, based on: serum level of PSA from 2,5 ng/ml to 20 ng/ml and/or abnormal digital rectal examination according to the referral physician
* Mental status: Patients must be able to understand the meaning of the study
* Informed consent: The patient must sign the appropriate Ethics Committee (EC) approved informed consent documents in the presence of the designated staff
Exclusion Criteria
* any contraindications for MRI
* any other conditions that might compromise patient's safety, based on the clinical judgment of the responsible urologist
* bilateral hip prosthesis
18 Years
MALE
No
Sponsors
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Tampere University Hospital
OTHER
Satakunta Central Hospital
OTHER
Central Finland Hospital District
OTHER
Memorial Sloan Kettering Cancer Center
OTHER
Mount Sinai Hospital, New York
OTHER
Turku University Hospital
OTHER_GOV
Responsible Party
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Locations
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Tampere University Hospital
Tampere, , Finland
Turku University Hospital
Turku, , Finland
Central Finland Central Hospital
Jyväskylä, , Finland
Satakunta Central Hospital
Pori, , Finland
Countries
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Central Contacts
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Facility Contacts
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Heikki Seikkula, MD
Role: primary
Marjo Seppänen, MD
Role: primary
Antti Kaipia, MD
Role: primary
Otto Ettala, MD
Role: primary
Peter Boström, MD
Role: backup
References
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Ettala O, Jambor I, Montoya Perez I, Seppanen M, Kaipia A, Seikkula H, Syvanen KT, Taimen P, Verho J, Steiner A, Saunavaara J, Saukko E, Loyttyniemi E, Sjoberg DD, Vickers A, Aronen H, Bostrom P. Individualised non-contrast MRI-based risk estimation and shared decision-making in men with a suspicion of prostate cancer: protocol for multicentre randomised controlled trial (multi-IMPROD V.2.0). BMJ Open. 2022 Apr 15;12(4):e053118. doi: 10.1136/bmjopen-2021-053118.
Related Links
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multi-IMPROD trial
IMPROD trial
Other Identifiers
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T326/2019
Identifier Type: -
Identifier Source: org_study_id