Improvement of Prostate Cancer Diagnosis: a Multi-center, Observational Evaluation of Pre-biopsy MRI-pathways
Recruiting
- Conditions
- Prostate cancer
- Registration Number
- NL-OMON22158
- Lead Sponsor
- /a
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 700
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.
Study & Design
- Study Type
- Observational non invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The follow-up of men in different mpMRI-‘first’ pathways with regard to detection rates of indolent- and csPCa and prostate biopsy rates during a follow-up period of three years.
- Secondary Outcome Measures
Name Time Method - For different biopsy strategies, the accuracy of the Gleason score (GS) of (MRDB) biopsies in predicting the definite GS at whole mount radical prostatectomy specimens.<br>- A cost-effectiveness assessment to analyze the different biopsy strategies.<br>- The histopathological results of biopsies in relation to mpMRI assessment.<br>- The value of the (MRI-based) risk calculator (e.g. ERSPC-RC3).<br>- The role of multidisciplinary team meetings in clinical shared-decision making.<br>- How to manage equivocal (PI-RADS 3) lesions.<br>- A comparison of targeted biopsy methods (MR-in bore, MR-TRUS fusion and MR-cognitive biopsies) and the additional value of systematic biopsy.