NL-OMON22158RecruitingNot Applicable
Improvement of Prostate Cancer Diagnosis: a Multi-center, Observational Evaluation of Pre-biopsy MRI-pathways
/a0 sites700 target enrollmentStarted: TBDLast updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Enrollment
- 700
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Observational
Eligibility Criteria
Inclusion Criteria
- •Biopsy-naïve men, aged 18-80 years.
- •- Clinical suspicion of prostate cancer (i.e. PSA = 3.0 ng/ml and/or abnormal DRE).
- •- Men must be able to comprehend and sign an informed consent and must be able to comprehend and sign an MRI screening form (to search for metal device/foreign bodies/claustrophobia).
Exclusion Criteria
- •- History of previous prostate biopsy.
- •- Already proven prostate cancer or history of PCa.
- •- Contraindications for an MRI scan (with gadolinium contrast).
- •- History of invasive treatments for BPH or lower urinary tract symptoms (LUTS), e.g. transurethral
- •resection of the prostate; heat, laser or ultrasound treatments in the last 12 months.
Investigators
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