Actively Recruiting
bpMRI and Risk Based Shared Clinical Decision Making in Prostate Cancer Diagnosis
Led by Turku University Hospital · Updated on 2021-11-23
600
Participants Needed
4
Research Sites
1141 weeks
Total Duration
On this page
Sponsors
T
Turku University Hospital
Lead Sponsor
T
Tampere University Hospital
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
bpMRI and Risk Based Shared Clinical Decision Making in Prostate Cancer Diagnosis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Able to speak Finnish
- Clinical suspicion of prostate cancer with PSA from 2.5 to 20 ng/ml and/or abnormal digital rectal examination
- Able to understand the study and its meaning
- Signed informed consent approved by the Ethics Committee
You will not qualify if you...
- Previous diagnosis of prostate cancer
- Contraindications for MRI
- Any condition compromising patient safety as judged by the urologist
- Bilateral hip prosthesis
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 4 locations
1
Central Finland Central Hospital
Jyväskylä, Finland, 40620
Actively Recruiting
2
Satakunta Central Hospital
Pori, Finland, 28500
Actively Recruiting
3
Tampere University Hospital
Tampere, Finland, 33520
Actively Recruiting
4
Turku University Hospital
Turku, Finland, 20521
Actively Recruiting
Research Team
P
Peter Boström, MD
CONTACT
O
Otto Ettala, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
DIAGNOSTIC
Number of Arms
2
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