bpMRI and Risk Based Shared Clinical Decision Making in Prostate Cancer Diagnosis
multiIMPROD2
Prebiopsy Magnetic Resonance Imaging in Men With Suspicion of Prostate Cancer - A Multi-centre Trial on Clinical Utility of IMPROD bpMRI in a Shared Decision Making Setting
1 other identifier
interventional
600
1 country
4
Brief Summary
The shortcoming of the pre-biopsy prostate MRI approach is the recommendation to biopsy all men post-MRI even if there is no lesion seen in MRI, ie. risk of PCa is very low. Therefore, the primary objective of this trial is to compare if there is a difference between significant cancer detection rate in men undergoing prostate biopsies after MRI scan compared to men undergoing post-MRI prostate biopsies only after a shared decision-making based on prostate cancer risk estimation. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable prostate-cancer
Started Feb 2020
Longer than P75 for not_applicable prostate-cancer
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 17, 2020
CompletedFirst Submitted
Initial submission to the registry
February 25, 2020
CompletedFirst Posted
Study publicly available on registry
February 27, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2041
ExpectedNovember 23, 2021
November 1, 2021
1.9 years
February 25, 2020
November 15, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Gleason 4+3=7 prostate cancer, baseline
The proportion of men with clinically significant prostate cancer (Gleason 4+3 \[ISUP grade group, the GGG, 3\]) prostate cancer or higher) in the control and intervention arms after primary diagnostic pathway
baseline
Secondary Outcomes (6)
Gleason 3+4=7 or lower prostate cancer, baseline
baseline
Men undergoing biopsies
baseline
Biopsy related complications
baseline
Gleason 4+3=7 prostate cancer, follow-up
during the five years of follow-up
the Memorial Anxiety Scale for Prostate Cancer -questionnaire (MAX-PC)
baseline, 6months, 12months
- +1 more secondary outcomes
Other Outcomes (3)
Biopsy criteria outcome
baseline
Calibration of the model
Baseline
Calibration of the model using biomarkers
Baseline
Study Arms (2)
Control
NO INTERVENTIONAfter 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).
Intervention
EXPERIMENTALAfter 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.
Interventions
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
You may qualify if:
- Age: 18 years or older
- 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
You may not qualify if:
- previous diagnosis of prostate cancer
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Turku University Hospitallead
- Tampere University Hospitalcollaborator
- Satakunta Central Hospitalcollaborator
- Central Finland Hospital Districtcollaborator
- Memorial Sloan Kettering Cancer Centercollaborator
- Mount Sinai Hospital, New Yorkcollaborator
Study Sites (4)
Central Finland Central Hospital
Jyväskylä, 40620, Finland
Satakunta Central Hospital
Pori, 28500, Finland
Tampere University Hospital
Tampere, 33520, Finland
Turku University Hospital
Turku, 20521, Finland
Related Publications (1)
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.
PMID: 35428621DERIVED
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER GOV
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 25, 2020
First Posted
February 27, 2020
Study Start
February 17, 2020
Primary Completion
December 31, 2021
Study Completion (Estimated)
December 31, 2041
Last Updated
November 23, 2021
Record last verified: 2021-11
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP
- Time Frame
- Study protocol and SAP will be published during spring 2020. MRI scans, MRI reports, calculator risk scores and clinical data will be published at the time of the actual publication.
- Access Criteria
- Publicly available. Free access.
Study protocol and statistical analysis plan will be published in peer-reviewed journal. Also, all MRI scans (pseudoanonymised), MRI reports, calculator risk scores and relevant clinical data will be provided online and publicly available similarly to previous IMPROD studies, see Links below. Informed consent form and analytic code are shared upon request.