Prostate cancer
Conditions
Interventions
None listed
Sponsors
None listed
Eligibility
Inclusion 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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| - 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. - A cost-effectiveness assessment to analyze the different biopsy strategies. - The histopathological results of biopsies in relation to mpMRI assessment. - The value of the (MRI-based) risk calculator (e.g. ERSPC-RC3). - The role of multidisciplinary team meetings in clinical shared-decision making. - How to manage equivocal (PI-RADS 3) lesions. - A comparison of targeted biopsy methods (MR-in bore, MR-TRUS fusion and MR-cognitive biopsies) and the additional value of systematic biopsy. | — |
Contacts
Public ContactB. Israël
Radboudumc
Outcome results
None listed