Status:
RECRUITING
bpMRI and Risk Based Shared Clinical Decision Making in Prostate Cancer Diagnosis
Lead Sponsor:
Turku University Hospital
Collaborating Sponsors:
Tampere University Hospital
Satakunta Central Hospital
Conditions:
Prostate Cancer
Eligibility:
MALE
18+ years
Phase:
NA
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 obj...
Detailed Description
Although most of the prostate cancers (PCas) are currently being diagnosed at early stage, at present, 30% of men are diagnosed with primarily metastatic disease. The need for better diagnostic method...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
February 17 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2041
Estimated Enrollment :
600 Patients enrolled
Trial Details
Trial ID
NCT04287088
Start Date
February 17 2020
End Date
December 31 2041
Last Update
November 23 2021
Active Locations (4)
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1
Central Finland Central Hospital
Jyväskylä, Finland, 40620
2
Satakunta Central Hospital
Pori, Finland, 28500
3
Tampere University Hospital
Tampere, Finland, 33520
4
Turku University Hospital
Turku, Finland, 20521